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JSS UNIVERSITY

SRI SHIVARATHREESHWARA NAGAR

MYSORE – 570 015

REGULATIONS AND SYLLABUS

Revised Regulations - 2012

MASTER OF PHARMACY (M.PHARM) COURSE

March- 2012

1

Master of Pharmacy (M.Pharm) course

SHORT TITLE AND COMMENCEMENT

These regulations shall be called ―THE REGULATIONS FOR THE M. PHARM COURSE

OF THE JSS UNIVERSITY, MYSORE‖. They shall come into force from the academic year

2012-2013 session. The regulation and syllabi are subject to modifications by the authorities

of the university from time to time.

SECTION I - REGULATIONS

1. ELIGIBILITY

A candidate who has passed B.Pharm degree examination of any recognized University and

has secured not less than 50% of the maximum marks (aggregate of four years) prescribed for

the qualification examination shall be eligible for the admission to the M.Pharm course.

1.1 Eligibility certificate

The Candidate who has passed the qualifying examination as specified in Regulation No.1

above from any other Universities other than the JSS University, before seeking admission to

any one of the constituent colleges shall obtain an Eligibility Certificate from the University

by remitting the prescribed fees along with application form, which shall be downloaded

from the University web site.

1.2 Physical fitness certificate

Every candidate before admission to the course shall submit to the Principal of the Institution

a Certificate of Medical Fitness from an authorized Medical Officer that the candidate is

physically fit to undergo the academic course and does not suffer from any disability or

contagious disease.

2. REGISTRATION

A Candidate admitted to the Master of Pharmacy course in any one of the constituent

colleges of the JSS University, Mysore, shall submit the prescribed application form for

registration duly filled along with prescribed fee and declaration in the format, to this

University through the constituent colleges within 60 days from the cut-off date prescribed

for Master of Pharmacy course for admission.

3. DURATION OF THE COURSE

The course of study including submission of dissertation shall be of 24 months (two years)

duration from the commencement of academic term. The study of M.Pharm course shall be of

annual system that includes M.Pharm part-I, extending for twelve months from the

commencement of academic term and M.Pharm part-II of twelve months duration.

No exemption shall be given from this period of study and training for any other experience

gained prior to the admission to the course.

2

4. MEDIUM OF INSTRUCTION

English shall be the medium of instruction for all the subjects of study for examinations of

the M. Pharm course.

5. WORKING DAYS IN AN ACADEMIC YEAR

Each academic year shall consist of not less than 220 working days.

6. COURSE OF STUDY

Table-I Branches in M.Pharm course

SI.No. Branch Code

1 Industrial Pharmacy MIP

2 Pharmaceutical Analysis MPA

3 Pharmaceutical Biotechnology MBT

4 Pharmaceutical Chemistry MPC

5 Pharmaceutics MPH

6 Pharmacognosy MPG

7 Pharmacology MPL

8 Phytopharmacy and Phytomedicine MPM

9 Pharmacy Practice MPP

10 Pharmaceutical Quality Assurance MQA

11 Pharmaceutical Regulatory Affairs MRA

12 Clinical Practice and Research MCP

3

Subjects to be studied in M.Pharm part-I in all the branches, the number of teaching

hours for theory and practical subjects are given in Table-II. All M.Pharm courses will have 4

theory and 4 practical subjects except for Clinical Practice and Research (CPR) which has 5

theory and 3 practicals.

Table-II: Subjects to be studied in different branches of M.Pharm course

SI. No. Branch of

specialization Paper Name of the Subject

Subject

Code

Hrs of study

Theory Practical

1 Industrial

Pharmacy I

Modern Analytical

Techniques MAT01 75 100

II Advanced Industrial

Pharmacy MIP02 75 100

III Biopharmaceutics &

Pharmacokinetics MIP03 75 100

IV Novel Drug Delivery

Systems MIP04 75 100

2 Pharmaceutical

Analysis I

Modern Analytical


II Quality Control and

Quality Assurance MPA02 75 100

III Advanced

Pharmaceutical Analysis MPA03 75 100

IV Food and Cosmetic

Analysis MPA04 75 100

3 Pharmaceutical

Biotechnology I

Bioinformatics and

Computational

Biotechnology

MBT01 75 100

II Microbial and Cellular

Biology MBT02 75 100

III Bioprocess Technology MBT03 75 100

IV

Advances in

Pharmaceutical

Biotechnology

MBT04 75 100

4 Pharmaceutical

Chemistry I

Modern Analytical


II Organic Chemistry MPC02 75 100

III Medicinal Chemistry and

Drug Design MPC03 75 100

IV Chemistry of Natural

Products MPC04 75 100

5 Pharmaceutics I Modern Analytical


II Advanced Pharmaceutics MPH02 75 100

III Biopharmaceutics and

Pharmacokinetics MPH03 75 100

IV Novel Drug Delivery

Systems MPH04 75 100

4

6 Pharmacognosy I Modern Analytical


II

Advanced

Pharmacognosy and

Phyto chemistry

MPG02 75 100

III Medicinal Plant

Biotechnology MPG03 75 100

IV Natural Products of

Medicinal Interest MPG04 75 100

7 Pharmacology I Modern Analytical


II Advanced Pharmacologv MPL02 75 100

III

Pharmacologica1 &

Toxicological Screening

Methods

MPL03 75 100

IV Drug Design and

Molecular Pharmacology MPL04 75 100

8 Phytopharmacy

and Phytomedicine I

Modern Analytical


II

Advanced

Pharmacognosy and

Phytochemistry

MPM02 75 100

III

Herbal Drug

Development and

Standardization

MPM03 75 100

IV Indian Systems of

Medicine MPM04 75 100

9 Pharmacy Practice I Clinical Pharmacy

Practice MPP01 75 100

II Pharmacotherapeutics-I MPP02 75 100

III Pharmacotherapeutics-II MPP03 75 100

IV

Hospital & Community

Pharmacy and Clinical

Research

MPP04 75 100

10 Pharmaceutical

Quality Assurance I

Modern Analytical


II

Pharmaceutical

Technology and Quality

management

MQA 02 75 100

III Pharmaceutical

Validation MQA 03 75 100

IV Quality Control and

Quality Assurance

MPA 04 75 100

5

11 Pharmaceutical

Regulatory Affairs I

Pharmaceutical Quality

Management MRA01 75 100

II Pharmaceutical

Regulations in India MRA02 75 100

III

International

Pharmaceutical

Regulations-I

MRA03 75 100

IV

International

Pharmaceutical

Regulations-II

MRA04 75 100

12 Clinical Practice

and Research I

Clinical Pharmacy

Practice MCP01 75 100

II Pharmacotherapeutics MCP02 75 100

III Clinical Research MCP03 75 100

IV

Clinical Development,

Guidelines and

regulations

MCP04 75 ----

V Research Methodology

and Biostatistics MCP05 75 ----

6

7. ATTENDANCE AND MONITORING PROGRESS OF STUDIES

i. Candidate pursuing M.Pharm Course shall study in the concerned department of

the institution for the entire period as a full time student. No candidate is

permitted to work as an employee in any laboratory/college/industry/ pharmacy,

etc., while studying postgraduate course.

ii. Each year shall be taken as a unit for the purpose of calculating attendance.

iii. Every student shall attend symposia, seminars, conferences, journal review

meetings and lectures during each year as prescribed by the

department/college/university and not absent himself/herself without valid

reason

iv. Candidate who has put in a minimum of 80% of attendance in the theory and

practical assignments separately shall be permitted to appear for M.Pharm part-I

examination.

v. Candidate who has put in a minimum of 80% of attendance in M.Pharm part -II

shall only be eligible to submit the dissertation.

vi. Any student who fails to complete the course in the manner stated above shall

not be permitted to appear for the University examinations.

vii. There shall be no condonation of lack of attendance in Post-Graduate courses.

viii. Every candidate shall maintain a laboratory work diary and record of his /her

participation in the training programmes conducted by the department such as

journal reviews, seminars, etc. The work diary/record shall be scrutinised and

certified by the Head of the Department and Head of the Institution.

8. EXAMINATION

There shall be an examination for M.Pharm part-I at the end of one academic year. For

M.Pharm Part-II, the examination shall be an evaluation of dissertation and viva-voce at the

end of the academic year.

9. SCHEME OF EXAMINATION

A. Sessional Examination

There shall be minimum of three sessional examinations in each subject of specialization

conducted by the colleges at regular intervals, both in theory and in practical which include

seminars.

The sessional marks shall be awarded out of a maximum of 50 for theory and practical

as follows:

Theory

a) Written examination : 30 marks (average of best two) 1.5 Hours Duration

b) Seminar : 20 marks

Total : 50 marks

Practical

a) Practical examination : 30 marks (average of best two) 04 Hours Duration

b) Lab work : 20 marks

Total : 50 marks

The candidates are required to score a minimum of 50% marks in each of the subjects

(Theory and practicals separately) in the sessional examination to be eligible to appear for

annual university examination in the respective subject.

III

1

1

1

1

1

1

1

1

7

B. University Examination (M.Pharm part-I)

There shall be two examinations (annual and supplementary) conducted by the university.

The examination shall be of written and practical. Each theory examination shall be of 03 hrs

duration and practical of 06 hrs duration. Scheme of examination for all the branches of

M.Pharm Part-I is given Table-III, IV and V.

C. Criteria for Pass

M.Pharm Part I

A candidate who secures 50% of marks in each subject in theory and practical separately

including Sessional marks and university examination marks together shall be declared to

have passed in M.Pharm part I examination. Candidate, who fails in theory or practical exam

in a subject, shall appear for both theory and practical in the subsequent examination in that

subject.

Candidates who fail in M.Pharm part-I examination shall be permitted to continue M.Pharm

part-II course and appear for the examination. However, the results of M. Pharm part-II of

such candidates shall not be declared unless the candidate passes M.Pharm part - I

examination.

M.Pharm. Part-II

Dissertation

i. Every candidate pursuing M. Pharm course is required to carry out work on a selected

research project under the guidance of a recognized postgraduate teacher. The results

of such a work shall be submitted in the form of a dissertation.

ii. The dissertation is aimed to train a postgraduate student in research methods and

techniques. It includes identification of the problem, formulation of a hypothesis,

review of literature, getting acquainted with recent advances, designing of a research

study, collection of data, critical analysis, and comparison of results and drawing

conclusions.

iii. The dissertation should be written under the following headings

1. Introduction

2. Aims or Objectives of study

3. Review of literature

4. Material and Methods

5. Results

6. Discussion

7. Conclusion

8. Summary

9. References

10. Tables

11. Annexure

iv. The written text of dissertation shall be not less than 50 pages and shall not exceed

150 pages excluding references, tables, questionnaires and other annexure. It should

be neatly typed with double line spacing on one side of the bond paper (A4size, 8.27"

x 11.69‖) and bound properly. Spiral binding should be avoided. The dissertation

shall be certified by the guide and co-guide if any, Head of the Department and Head

of the Institution. The dissertation shall be submitted at least one month before the

end of M. Pharm Part II term.

8

v. A guide shall be a full time post graduate teacher of the institution for supervision of

dissertation work. However a co - guide can be opted wherever required.

D. Submission of Dissertation

Three copies of the dissertation duly certified by the guide, head of the department and the

principal shall be submitted to the university for evaluation.

E. Viva-Voce Examination

The Viva-Voce examination shall aim at assessing the depth of knowledge, logical reasoning,

confidence and oral communication skills.

The Viva-Voce examination shall be held after the submission of dissertation. If any

candidate fails to submit the dissertation on or before the date prescribed, his/her Viva-Voce

shall be conducted during the subsequent examination which shall not be earlier than six

months from the date fixed in the first instance.

Examiners: There shall be at least two examiners in each branch of specialization, out of

them one shall be external examiner and the other one shall be the internal examiner (the

guide).

F. Distribution of Marks for M. Pharm Part-II Examination

Total- 200 marks, Dissertation-150 marks, Viva- Voce-50 marks.

The dissertation and viva-voce shall be valued, by the examiners together appointed by the

university.

9

M.PHARM PART – I EXAMINATION

Table – III: Scheme of Examination for all Branches (Except M.Pharm Clinical Practice & Research)

Subject Theory Examination

Total

Marks

Practical Examination

Total

Marks

Sessional

Marks

Annual Sessional

Marks

Annual

Duration

(Hrs)

Marks Duration

(Hrs)

Marks

Paper – I

50 03 100 150 50 06 100 150

Paper – II

50 03 100 150 50 06 100 150

Paper – III

50 03 100 150 50 06 100 150

Paper – IV

50 03 100 150 50 06 100 150

Total 600 600

10

M.PHARM PART – I EXAMINATION

Table – IV: Scheme of Examination for M.Pharm Clinical Practice & Research

Subject Theory Examination

Total

Marks

Practical Examination

Total

Marks

Sessional

Marks

Annual Sessional

Marks

Annual

Duration

(Hrs)

Marks Duration

(Hrs)

Marks

Paper – I

50 03 100 150 50 06 100 150

Paper – II

50 03 100 150 50 06 100 150

Paper – III

50 03 100 150 50 06 100 150

Paper – IV

50 03 100 150 -- -- -- --

Paper –V

50 03 100 150 -- -- -- --

Total 750 450

Table –V: Consolidated marks for M.Pharm Part – I and Part – II

Part - I Part – II Grand Total

1200 200 1400

11

G. Minimum marks for passing M.Pharm Part-II

The minimum marks for pass in M.Pharm Part II shall be 50% of the marks of dissertation

and viva voce and an aggregate of 100 marks out of 200 marks.

H. Class shall be declared on the basis of the aggregate of marks scored in M.Pharm

part-I and part-II as follows:

(1) 75% and above -- Distinction.

(2) 60% & above but less than 75% -- First class.

(3) 50% & above but less than 60% -- Second class.

I. Revaluation / Retotaling of answer paper

There shall be no revaluation of the answer papers of failed candidates in any Post-Graduate

examination. However, the failed candidate shall apply for re-totaling through their College.

10. NUMBER OF APPEARANCE(S)

A Candidate registered for Two years M. Pharmacy Post-Graduate Degree course must

qualify in the Examinations within four years of the date of his / her admission.

11. DURATION FOR COMPLETION OF THE COURSE OF STUDY

The duration for the completion of the course shall be fixed as double the time of the course

and the students have to pass within the said period otherwise they have to get fresh

admission.

12. RE-ADMISSION AFTER BREAK OF STUDY

Re-admission shall be made as per the University Common Regulations duly condoning the

break of study for all courses.

13. AUTHORITY TO ISSUE TRANSCRIPT

The Registrar shall be the Authority for issuing Transcript of marks after remitting the

prescribed fee to the University.

13

Course Contents

SI.No. Branch Code Page

No.

1 Industrial Pharmacy MIP 15-26

2 Pharmaceutical Analysis MPA 27-36

3 Pharmaceutical Biotechnology MBT 37-49

4 Pharmaceutical Chemistry MPC 51-61

5 Pharmaceutics MPH 63-74

6 Pharmacognosy MPG 75-85

7 Pharmacology MPL 87-98

8 Phytopharmacy and Phytomedicine MPM 99-111

9 Pharmacy Practice MPP 113-125

10 Pharmaceutical Quality Assurance MQA 127-136

11 Pharmaceutical Regulatory Affairs MRA 137-145

12 Clinical Practice and Research MCP 147-162

15

M.Pharm - Industrial Pharmacy (MIP)

Paper Subject Code

I Modern Analytical Techniques MAT 01

II Advanced Industrial Pharmacy MIP 02

III Biopharmaceutics & Pharmacokinetics MIP 03

IV Novel Drug Delivery Systems MIP 04

16

PAPER - I

Modern Analytical Techniques

Scope

This subject deals with various advanced analytical instrumental techniques for

identification, characterization and quantification of drugs. Instruments dealt are NMR,

Mass spectrometer, IR, HPLC, GC etc.

Objectives After completion of course student is able to know,

the analysis of various drugs in single and combination dosage forms

theoretical and practical skills of the instruments

interpretation of the NMR, Mass and IR spectra of various organic compounds

THEORY 75 HOURS

1. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated

with UV-Visible spectroscopy, Choice of solvents and solvent effect,

Spectrophotometric titrations, Wood ward – Fiesure rule, Applications of UV-

Visible spectroscopy.

06 Hrs

2. Spectroflourimetry: Theory of Fluorescence, Factors affecting fluorescence,

Quenchers, Instrumentation and Applications of fluorescence spectrophotometer. 04 Hrs

3. Flame emission spectroscopy and Atomic absorption spectroscopy: Principle,

Instrumentation, Interferences and Applications. 04 Hrs

4. IR spectroscopy: Theory, Modes of Molecular vibrations, Sample handling,

Instrumentation of Dispersive and Fourier - Transform IR Spectrometer, Factors

affecting vibrational frequencies, ATR-IR, Interpretation and Applications of IR

spectroscopy

08 Hrs

5. NMR spectroscopy: Quantum numbers and their role in NMR, Principle,

Instrumentation, Solvent requirement in NMR, Relaxation process, NMR signals in

various compounds, Chemical shift, Factors influencing chemical shift, Spin-Spin

coupling, Coupling constant, Nuclear magnetic double resonance, Brief outline of

principles of FT-NMR with reference to 13

CNMR: Spin spin and spin lattice

relaxation phenomenon. 13

C NMR, 1-D and 2-D NMR, NOESY and COSY

techniques, Interpretation and Applications of NMR spectroscopy.

14 Hrs

6. Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy,

Different types of ionization like electron impact, chemical, field, FAB and

MALDI, Analyzers of Quadrupole and Time of Flight, Mass fragmentation and its

rules, Fragmentation of important functional groups like alcohols, amines, carbonyl

groups and alkanes, Meta stable ions, Mc Lafferty rearrangement, Ring rule,

Isotopic peaks, Tandem Mass Instruments, Interpretation and Applications of Mass

spectroscopy.

10 Hrs

7. Chromatography: Principle, apparatus, instrumentation, chromatographic

parameters, factors affecting resolution and applications of the following:

a) Paper chromatography b) Thin Layer chromatography

c) Ion exchange chromatography d) Column chromatography

e) Gas chromatography f) GC-MS

g) High Performance Liquid chromatography h) LC-MS

i) High Performance Thin Layer chromatography

k) Super critical fluid chromatography l) Affinity chromatography

10 Hrs

17

8. Electrophoresis: Principle, Instrumentation, Working conditions, factors affecting

separation and applications of the following:

a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis d)

Zone electrophoresis e) Moving boundary electrophoresis f) Iso electric focusing

06 Hrs

9. X ray Crystallography: Production of X rays, Different X ray methods, Bragg‘s

law, Rotating crystal technique, X ray powder technique, Types of crystals,

Interpretation of diffraction patterns and applications of X-ray diffraction.

03 Hrs

10. Optical Rotatory Dispersion: Principle, Plain curves, Cotton effect, Circular

Dichroism, Measurement of rotaion angle in ORD and applications 03 Hrs

11. Radioimmunoassay: Importance, various components, Principle, Different

methods, Limitation and Applications of Radio immuno assay. 03 Hrs

12. Statistical Analysis: Introduction, Significance of statistical methods, normal

distribution, probability, degree of freedom, standard deviation, correlation,

variance, accuracy, precision, classification of errors, reliability of results,

confidence interval, test for statistical significance – Students T test, F test, Chi

square test, Correlation and regression.

REFERENCES 1. Spectrometric Identification of Organic compounds - Robert M Silverstein,

Sixth edition, John Wiley & Sons, 2004.

2. Fundamentals of Statistics – Elhance, Kitab Mahal.

3. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler,

Timothy A. Nieman, 5th

edition, Eastern press, Bangalore, 1998.

4. Vogel‘s Text book of quantitative chemical analysis - Jeffery, Basset,

Mendham, Denney, 5th

edition, ELDS, 1991.

5. Instrumental methods of analysis – Willards, 7th

edition, CBS

publishers.

6. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th

edition, CBS Publishers, New Delhi, 1997.

7. Organic Spectroscopy - William Kemp, 3rd

edition, ELBS, 1991.

8. Quantitative analysis of Pharmaceutical formulations by HPTLC - P D

Sethi, CBS Publishers, New Delhi.

9. Pharmacutical Analysis - Higuchi, Brochmman and Hassen, 2nd

Edition,

Wiley – Interscience Publications, 1961.

10. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi,

3rd

Edition, CBS Publishers, New Delhi, 1997.

11. Pharmaceutical Analysis- Modern methods – Part B - J W Munson,

Volume 11, Marcel Dekker Series

12. Analytical Profiles of Drug substances – Klaus Florey, Volume 1 – 20,

Elsevier, 2005

13. Analytical Profiles of Drug substances and Excipients – Harry G Brittain,

Volume 21 – 30, Elsevier, 2005.

Journals:

1. Indian Journal of Pharmaceutical Sciences

2. Indian Drugs

3. Indian Journal of Pharmaceutical Education and Research

4. Asian Journal of Chemistry

5. Indian Journal of Chemical Technology

6. Journal of Chromatographic Science

04 Hrs

18

Modern Analytical Techniques (Practicals) 75 Hrs

Minimum 15 experiments to be conducted

1. Use of UV Vis spectrophotometer for analysis of pharmacopoeial compounds and their

formulations (4 Experiments).

2. Simultaneous estimation of multi component containing formulations by UV

spectrophotometry. (4 Experiments).

3. Effect of pH and solvent on UV spectrum of certain drugs.

4. Experiments based on HPLC and Gas Chromatography (2 Experiments)

5. Experiments on factors affecting the absorbance/fluorescence in UV

spectroscopy/Fluorimetry.

6. Separation and quantitative analysis of various components by TLC and HPTLC

techniques (1 Experiment in each technique)

7. Interpretation of IR, NMR and MASS spectra (2 compound each)

8. Gradient elution and other technique in column Chromatography (Minor Experiment)

9. Separation by electrophoresis

19

PAPER - II

Advanced Industrial Pharmacy

Scope: Course designed to impart advanced knowledge and skills required to learn various

aspects and concepts at pharmaceutical industries

Objectives: At completion of this course it is expected that students will be able to –

understand the elements of preformulation studies & Pilot Plant Scale up Technique.

understand the Inventory, Material & Maintenance Management.

learn Human Resource Development and Project management.

understand cGMP and Validation concepts.

study ISO 9000, ISO 14000, ISO 22000 series and Stability studies.

THEORY 75 HOURS

1. Preformulation Studies:

Introduction, organoleptic properties, purity, particle size, shape and surface area.

Solubility, methods to improve solubility of drugs: Surfactants & its importance,

co-solvency. Techniques for the study of crystal properties and polymorphism.

Preformulation stability studies.

05 Hrs

2. Pilot Plant Scale up Techniques, Pharmaceutical Production Planning and

Control

Significance of pilot plant scale up study, Large scale manufacturing techniques

(formula, equipment, process, stability and quality control) of solids, liquids,

semisolid and parenteral dosage forms, Guidelines USFDA-SUPAC (Scale up

post approve changes)

General principles, Types of production systems, calculation of standard costs,

production or process planning, Routing, Loading, Scheduling, Dispatching of

records, Production control.

08Hrs

3. Pharmaceutical Pre-approval inspections, Post operational activities

Evaluation of FDA, Pre-new drug application approval inspection, FDA risk

based approach to inspections, Critical role Pharmaceutical scientist in product

development and preparing for pre-approval inspection, Training requirements in

product development, System based pre-approval inspection, cGMP risk

assessment, and Management strategy, concepts in quality by design for drug

development manufacture, Equipment cleaning during pharmaceutical product

development and its importance to pre-approval inspection

Distribution , Recalled products, Returned products, Complaints and adverse

effects, Drug product salvaging documents and formats

07Hrs

4. Principle of Management, Material Management & Inventory

Management, Out sourcing

Functions of management, Decision making, Styles of management,

Management by objectives.

Value analysis, Centralized & Decentralized purchasing, Vendor development,

Buying techniques, Purchasing cycles and procedures, Stores management,

Salvaging and Disposing of scrap & Surplus.

Inventory categories, Selective inventory control, Lead time, Stock out, Safety

stock, Reorder quantity methods & EOQ, Reorder time methods, Modern

inventory management systems, costs in inventory, Evaluation of inventory

performance.

08

Hrs

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Manufacturing and packaging out sourcing, Analytical out sourcing, other

services out sourcing.

5. Validation, Stability Studies

Validation – Concepts of TQM, Process, Analytical method and cleaning method

validation, validation master plan. ICH and WHO guidelines for validation and

calibration of equipments, Validation of computer systems, Validation of specific

dosage forms, Calibration of master plan, Documents & formats.

Accelerated stability testing & shelf life calculation, WHO and ICH stability

testing guideline, Stability zones, Photostability testing guidelines, ICH stability

guidelines for biological and biotechnological products, Stress testing

programmes: Drug substance characterization studies, Drug substances solid state

characterization and stability.

06 Hrs

6. Human Resource Management, Pharmaceutical Project Management

Organizational context, Job design and Job analysis, Human resource planning,

recruitment, Selections, Placement, Job evaluations, Performance appraisal,

globalization & Human resource management, Total quality & human resource

management, Recent techniques in human resource management, Job

enlargement and enrichment.

Project management of chemical, analytical and formulation development, Project

planning from basic concept to system applications, Strategic project management

at the project level & portfolio level, Project management and out sourcing drug

development, Project management functions

09

Hrs

7. ISO 9000, ISO 14000, ISO 22000 series, CTD and eCTD, Accreditation

&Regulatory aspects

ISO 9000, ISO 14000, ISO 22000series - Salient features

CTD &eCTD –Salient features & Concepts

NABL accreditation and accreditation procedure, Patent regime and

intellectual property rights

Regulatory aspects related to Pharma Industries in India, UD FDA and

European commission, ANDA and NDA

07

Hrs

8. Current Good manufacturing practices Manufacturing facilities for tablets, capsule, liquid orals, semisolids and

parenterals as per schedule M. Certification for pharmaceutical industries, US

federal standard 209 E: Class designation, testing and monitoring reports,

calibrations, URS, FAT, DQ, SAT, IQ, OQ, PQ of machines and equipment,

WHO GMP minimum document check list, Schedule U and U1. Master formula

record as per WHO GMP and US FDA. Drug Master files US FDA, Preparation

for WHO GMP audit, preparation of Site Master File, environment management

system clauses. Technology transfer guidance.

10

Hrs

9. Equipment, Compaction of powders, Compression of tablets and Quality

Control Design, Size, Location & Construction of equipments, Equipment identification,

Equipment log, Cleaning & Maintenance, Automatic, Mechanical & Electronic

equipments , Planned preventive maintenance program, Documents and formats

Compaction of powders and measurement of forces within the powder mass.

Compression physics of tablet compression and effect of particle size, moisture

content, Lubrication etc on strength of tablets

Evaluation of tablets, capsules, semisolid dosage forms, liquid orals, transdermal

and controlled release products.

04

Hrs

21

10. Environmental Pollution, Pollution control and Effluent analysis, Industrial

Hazards and Plant safety.

Water pollution, Water pollution and abatement and Effluent treatment, Air

pollution, Air pollution control devices, Solid waste management, Noise pollution

and abatement, Effluent analysis and Treatment methods, Effluent treatment in

formulation plants, synthetic drug industry, Fermentation industry.

Accidents and Industrial Psychology, Chemical hazards, Management of over-

exposure to chemicals, Gas hazards and handling of gases, Dust explosion,

Control of dust explosion, Fire and explosion, Safety management, Elements of

safety program, Drinking water standards as per EPA, USA, WHO and BIS.

REFERENCES:

1. Evans, Anderson, Sweeney and Williams. Applied production and

operations management 3rd

edition, West publishing company Ltd. St. Paul.

2. Peter F. Drucker. Management (task, responsibility and practices) Allied

publication. Bangalore.

3. HWTomski. A Text of Pharmacy management Kogan Page Ltd. London.

4. Harold Koonz, Cyril a Donnell, Heinz, Weihrich Essentials of

Management McGraw Hill Book Company. New Delhi.

5. Lachman L Liberman. Theory and Practice of Industrial Pharmacy by 3rd

edition

6. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good

Manufacturing of Pharmaceuticals (A Plan for total quality control). 3rd

Edition. Bhalani publishing house Mumbai.

7. ISO 9000 and 14000 Series

8. The Pharmaceuticl Sciences; the Pharma Path way ‗Pure and applied

Pharmacy‘ by D.A Sawant, Pragathi Books Pvt Ltd.

9. Pharmaceutical Production and management by C.V.S. Subrahmanyam,

Vallabh Prakashan.

10. Pharmaceutical Pre-approval ingredients by Martin D Haynes-III. 2nd

edition, Informal Health Care, Newyork.

11. Pharmaceutical project management by Tony Kennedy.

12. Pharmaceutical Quality Assurance by Manohar A Potdar, 2010 Nirali

Prakshan, Pune.

Journals


2. Indian Drugs

3. Journal of Scientific and Industrial Research

4. Drug Development and Industrial Pharmacy

08

Hrs

22

Advanced Industrial Pharmacy (Practicals) 75 Hrs

Suggested practical experiments (at least 15 experiments to be conducted)

1. To study the effect of pH on the solubility of drugs, (2 experiments)

2. Accelerated stability of drugs in solution dosage forms(2 experiments)

3. Effect of pH on the stability of drugs in solution at elevated temperature

(2 experiments)

4. Improved solubility of drugs using surfactant systems (2 experiments)

5. Improved solubility of drugs using co-solvency method (2 experiments)

6. GMP in three different formulations (Tablets, liquid orals and semi solids)

(2 experiments)

7. Effluent treatment from bulk drug and formulation industry. (2 experiments)

8. Equipment validation (4 Equipments) (2 experiments)

Case studies & Assignments

1. Production planning (Weekly and monthly)

2. Human resource development (Industrial case to be discussed)

3. Production scheduling (pertaining to particular industry)

4. Layout plan for different dosage form.

5. Production protocol for tablets liquids and semisolid dosage forms.

GC .

.\:

IE

23

PAPER - III

Biopharmaceutics and Pharmacokinetics

Scope

This course is designed to impart knowledge and skills necessary for dose calculations, dose

adjustments and to apply biopharmaceutics theories in practical problem solving. Basic

theoretical discussions of the principles of biopharmaceutics and pharmacokinetics are

provided to help the students‘ to clarify the concepts.

Objectives At completion of this course it is expected that students will be able to –

define the basic concepts in biopharmaceutics and pharmacokinetics.

use raw data and derive the pharmacokinetic models and parameters the best describe

the process of drug absorption, distribution, metabolism and elimination.

critically evaluate biopharmaceutic studies involving drug product equivalency.

design and evaluate dosage regimens of the drugs using pharmacokinetic and

biopharmaceutic parameters.

detect potential clinical pharmacokinetic problems and apply basic pharmacokinetic

principles to solve them

THEORY 75 HRS

1. Absorption of Drugs: Structure of Cell membrane, Gastro-intestinal

absorption of drugs, mechanisms of drug absorption, Factors affecting drug

absorption: Biological, Physiological, Physicochemical, pharmaceutical.

Absorption of drugs from non-peroral routes, Methods of determining

absorption: In-vitro, in-situ and In-vivo methods.

10 Hrs

2. Bioavailability: Objectives and considerations in bioavailability studies,

Concept of equivalents, measurement of bioavailability, Determination of the

rate of absorption, Bioequivalence and its importance, bioequivalence

studies.

08 Hrs

3. Dissolution: Noyes - Whitney's dissolution rate law, Study of various

approaches to improve dissolution poorly soluble drugs, In-vitro dissolution

testing models, In-vitro - In-vivo correlation.

08 Hrs

4. Drug Distribution: Factors affecting drug distribution, Volume of

distribution, Protein binding – factors affecting, significance and kinetics of

protein binding.

04 Hrs

5. Biotransformation: Phase I (Oxidative, reductive and hydrolytic reactions)

and Phase II reactions (conjugation), Factors affecting biotransformation. 05 Hrs

6. Pharmacokinetics: Basic considerations, Pharmacokinetic models,

Compartment modeling: One compartment model- IV bolus, IV infusion,

Extra-vascular; Multi Compartment models; Two compartment - model - IV

bolus, IV infusion, Extra-vascular, Three Compartment model in brief,

Application of pharmacokinetics in new drug development and designing of

dosage forms and Novel drug delivery systems.

20 Hrs

7. Non-Linear Pharmacokinetics: Cause of non-linearity, Michaelis - Menten

equation, Estimation Kmax and Vmax. 05 Hrs

24

8. Excretion Of Drugs: Renal and non-renal excretion, Concept of clearance -

Renal clearance, Organ clearance & Hepatic clearance. 05 Hrs

9. Dosage Regimen: Multiple dosing with respect to IV and oral route, Concept

of loading dose, maintenance dose, Accumulation index, Adjustment of

dosage in renal and hepatic impairment, Individualization of therapy,

Therapeutic Drug Monitoring.

10 Hrs

REFERENCES

1. Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi, 4th edition,

Philadelphia, Lea and Febiger, 1991

2. Biopharmaceutics and Pharmacokinetics, A. Treatise, D .M. Brahmankar and Sunil B.

J aiswal., Vallab Prakashan, Pitampura, Delhi

3. Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land YuABC, 2nd

edition, Connecticut Appleton Century Crofts, 1985

4. Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R. Hiremath,

Prism Book

5. Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel Dekker Inc.,

New York, 1982

6. Current Concepts in Pharmaceutical Sciences: Biopharmaceutics, Swarbrick. J, Lea

and Febiger, Philadelphia, 1970

7. Clinical Pharmacokinetics, Concepts and Applications 3rd edition by Malcolm

Rowland and Thom~ N. Tozer, Lea and Febiger, Philadelphia, 1995

8. Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack Publishing

Company, Pennsylvania 1989

9. Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 4th edition,

revised and expande by Robert. E. Notari, Marcel Dekker Inc, New York and Basel,

1987.

10. Biopharmaceutics and Relevant Pharmacokinetics by John. G Wagner and M.

Pemarowski, 1st edition, Drug Intelligence Publications, Hamilton, Illinois, 1971.

11. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G.

Boylan, Marcel Dekker Inc, New York, 1996.

Biopharmaceutics and Pharmacokinetics (Practicals) 75 Hrs

Suggested Practical Exercises: (At least 15 experiments to be conducted)

1. Improvement of dissolution characteristics of slightly soluble drugs by Various Solid

dispersion techniques and solvent deposition systems (4 experiments).

2. Comparison of dissolution of two different marketed products /brands (2

experiments).

3. Influence of polymorphism on solubility and dissolution (2 experiments).

4. Protein binding studies of a highly protein bound drug & poorly protein bound drug.

(2 experiments).

5. Bioavailability studies of Paracetamol by salivary data (1 experiment).

6. Calculation of Ka, Ke, t 1/2, Cmax and Tmax for two sets of data (2 experiments).

7. Calculation of bioavailability from the given urinary excretion data for two drugs (2

experiments)

8. Calculation of AUC and bioequivalence from the given data for two drugs (2

experiment).

25

PAPER - IV

Novel Drug Delivery Systems

Scope

This course is designed to impart knowledge on the area of advances in novel drug delivery

systems.

Objectives

Upon completion of the course student shall be able to

understand various approaches for development of novel drug delivery systems.

understand the criteria for selection of drugs and polymers for the development of

Novel drug delivery systems, their formulation and evaluation.

THEORY 75 HOURS

1. Sustained Release Formulations: Introduction, terminology/definitions and

rationale, advantages and disadvantages. Types of control release products,

factors influencing the design and performance of SR formulations.

Physicochemical and biological properties of drugs relevant to sustained

release formulations.

06 Hrs

2. Polymer Science: Introduction, classification, properties, advantages and

application of polymers in formulation of controlled drug delivery systems. 06 Hrs

3. Concept and System Design for the Rate-Controlled Drug Delivery: Introduction, classification, fundamental concepts and technical principles of

rate-pre-programmed DDS, activation- modulated DDS, feedback-regulated

DDS. Effects of system parameters on controlled release drug delivery.

06 Hrs

4. Oral Drug Delivery and Delivery Systems: Introduction, development of

novel DDS for oral controlled release drug administration, modulation of GI

transit time. Approaches to extend GI transit time of DDS.

08 Hrs

5. Mucosal Drug Delivery: Introduction, Principles of muco adhesion, concepts,

advantages and disadvantages, transmucosal permeability, formulation and

evaluation of buccal, nasal and pulmonary drug delivery systems.

08 Hrs

6. Ocular Drug Delivery Systems: Introduction, controlled ocular drug delivery-

requisites & approaches for ocular drug delivery devices-matrix type, capsular

type & implantable types.

06 Hrs

7. Transdermal Drug Delivery Systems: Introduction, Permeation through skin,

factors affecting permeation, permeation enhancers, basic components of

TDDS formulation and evaluation of transdermal drug delivery systems.

07 Hrs

8. Parenteral Drug Delivery Systems: Definition, advantages and

disadvantages, Approaches for injectable controlled release formulations with

examples, formulation and evaluation of Implantable drug delivery systems.

06 Hrs

9. Intrauterine Drug Delivery Systems: Introduction, Development of intra

uterine devices (IUDs), advantages and disadvantages, types, copper IUDs,

hormone-releasing IUDs.

06 Hrs

10. Targeted Drug Delivery Systems: Concept. Advantages and disadvantages,

biological processes and event involved in drug targeting, drug targeting

through various systems like nanoparticles, liposomes, resealed erythrocytes,

microspheres, magnetic microspheres, ethosomes, aquasomes, niosomes,

phytosomes and monoclonal antibodies.

08 Hrs

26

11. Protein and Peptide Drug Delivery: Manifestation of protein instability and

stability. Drug delivery systems for proteins and peptides with special reference

to oral & nasal routes.

04 Hrs

12. Hydrogels: Structure and properties, classification- diffusion controlled,

swelling controlled, chemically controlled and environmentally controlled.

Applications.

04Hrs

REFERENCES

1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded,

Marcel Dekker, Inc., New York, 1992.

2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker,

Inc., New York, 1992.

3. Encyclopedia of controlled delivery, Editor- Edith Mathiowitz, Published by Wiley

Interscience Publication, John Wiley and Sons, Inc, New York! Chichester/Weinheim

4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New

Delhi, First edition 1997 (reprint in 2001).

5. S.P.Vyas and R.K.Khar, Controlled Drug Delivery - concepts and advances, Vallabh

Prakashan, New Delhi, First edition 2002.

Journals

1. Indian Journal of Pharmaceutical Sciences (IPA)

2. Indian drugs (IDMA)

3. Journal of controlled release (Elsevier Sciences) desirable

4. Drug Development and Industrial Pharmacy (Marcel & Decker) desirable

Novel Drug Delivery Systems (Practicals)

Suggested practical experiments (at least 15 experiments to conducted)

1. Preparation and evaluation of albumin microspheres

2. Preparation and evaluation of microcapsules by different microencapsulation

techniques

3. Preparation and evaluation of matrix tablets using various polymers

4. Study of diffusion of drugs through various polymeric membranes

5. Preparation and in vitro evaluation of buccal mucoadhesives

6. Preparation and evaluation of transdermal films

7. Preparation and evaluation of hydrodynamically balanced tablets

8. Study of in vitro dissolution of various sustained release formulations of marketed

products

27

M. Pharm - Pharmaceutical Analysis (MPA)

Paper Subject Code

I Modern Analytical Techniques MAT01

II Quality control and Quality Assurance MPA02

III Advanced Pharmaceutical Analysis MPA03

IV Food and cosmetic analysis MPA04

28

PAPER - I


Scope

This subject deals with various advanced analytical instrumental techniques for identification,

characterization and quantification of drugs. Instruments dealt are NMR, Mass spectrometer,

IR, HPLC, GC etc.

Objectives

After completion of course student is able to know,




THEORY 75 HOURS

1. UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation

associated with UV-Visible spectroscopy, Choice of solvents and solvent effect,



06 Hrs








spectroscopy

08 Hrs


Instrumentation, Solvent requirement in NMR, Relaxation process, NMR signals

in various compounds, Chemical shift, Factors influencing chemical shift, Spin-

Spin coupling, Coupling constant, Nuclear magnetic double resonance, Brief

outline of principles of FT-NMR with reference to 13

CNMR: Spin spin and spin

lattice relaxation phenomenon. 13



14 Hrs




rules, Fragmentation of important functional groups like alcohols, amines,

carbonyl groups and alkanes, Meta stable ions, Mc Lafferty rearrangement, Ring

rule, Isotopic peaks, Tandem Mass Instruments, Interpretation and Applications of

Mass spectroscopy.

10 Hrs









10 Hrs

29





06 Hrs




03 Hrs










REFERENCES 1. Spectrometric Identification of Organic compounds - Robert M Silverstein,










edition, CBS publishers.


edition,

CBS Publishers, New Delhi, 1997.



8. Quantitative analysis of Pharmaceutical formulations by HPTLC - P D Sethi,

CBS Publishers, New Delhi.


Edition, Wiley

– Interscience Publications, 1961.

10. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd


11. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume

11, Marcel Dekker Series


Elsevier, 2005



Journals


2. Indian Drugs





04 Hrs

30
















31

PAPER – II

Quality Control and Quality Assurance

Scope

This course deals with the various aspects of quality control and quality assurance aspects of

pharmaceutical industries. It covers the important aspects like cGMP, QC tests,

documentation, quality certifications, GLP and regulatory affairs.

Objectives

At the completion of this subject it is expected that the student will be able to know

the cGMP aspects in a pharmaceutical industry

to appreciate the importance of documentation

to understand the scope of quality certifications applicable to Pharmaceutical industries

to understand the responsibilities of QA & QC departments.

THEORY 75 HOURS

1. Definition - Quality control and Quality assurance, concept and philosophy of

TQM, GMP, ICH, Brief study of ICH common technical documents – Q1-Q11,

Quality by design, six sigma concept, ISO 9000 & 14000.

07 Hrs

2. Organization and personnel responsibilities, training, hygiene and personal

records, drug industry location, design, construction and plant lay out,

maintenance, sanitation, environmental control, utilities and maintenance of

sterile areas, control of contamination and Good Warehousing Practice.

09 Hrs

3. Equipments and raw materials: Equipments selection, purchase specifications,

maintenance, clean in place, purchase specifications and maintenance of stores for

raw materials, selection of vendors.

07 Hrs

4. Quality control test for containers, closures and secondary packing materials 06 Hrs

5. Document maintenance in pharmaceutical industry: Batch Formula Record,

Master Formula Record, Quality audit reports and documents, quality reports,

distribution records, Common Technical Document and Drug Master Files,

Medical Devices, Electronic Common Technical Documentation, complaints and

evaluation of complaints, Handling of return good, recalling and waste disposal.

08 Hrs

6. In process quality control and finished products quality control for following

formulation in pharma industry: tablets, capsules, ointments, suppositories,

creams, parenterals, ophthalmic and surgical products.

08 Hrs

7. Production controls: Written procedures, change control, contamination control,

sterile products, aseptic process control, packaging. 05 Hrs

8. Manufacturing operations and controls: Sanitation of manufacturing premises,

mix-ups and cross contamination, processing of intermediates and bulk products,

packaging operations, IPQC, release of finished product, process deviations,

charge-in of components, time limitations on production, drug product inspection,

expiration dating, calculation of yields, production record review

10 Hrs

9. GLP: Scope of GLP, Quality assurance unit, SOP, protocols for conduct of

clinical & non clinical testing, control on animal house, report preparation and

documentation.

08 Hrs

10. NABL certification and accreditation procedure, Patent regime and intellectual

property rights. 07 Hrs

=

32

REFERENCES 1. Quality Assurance Guide by organization of Pharmaceutical Procedures of India, 3

rd

revised edition, Volume I & II, Mumbai, 1996.

2. Good Laboratory Practice Regulations, 2nd

Edition, Sandy Weinberg Vol. 69, Marcel

Dekker Series, 1995.

3. Quality Assurance of Pharmaceuticals- A compedium of Guide lines and Related

materials Vol I & II, 2nd

edition, WHO Publications, 1999.

4. How to Practice GMP‘s – P P Sharma, Vandana Publications, Agra, 1991.

5. The International Pharmacopoeia – vol I, II, III, IV & V - General Methods of

Analysis and Quality specification for Pharmaceutical Substances, Excepients and

Dosage forms, 3rd

edition, WHO, Geneva, 2005.

6. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel Dekker

Series, 1989.

7. ICH guidelines

8. ISO 9000 and total quality management

9. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4th

edition, Susmit

Publishers, 2006.

10. QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000.

11. Good Manufacturing Practices for Pharmaceuticals a plan for total quality control –

Sidney H. Willig, Vol. 52, 3rd

edition, Marcel Dekker Series.

Quality Control and Quality Assurance (Practicals) 75 Hrs


1. In process quality control tests for tablets, capsules, parenterals and creams

2. Quality control tests for secondary packing materials

3. Assay of raw materials as per official monographs

4. Testing of related and foreign substances in drugs and raw materials

5. Planning and design of plant layouts

33

PAPER - III

Advanced Pharmaceutical Analysis

Scope

This subject deals with the various aspects of reagents, quantitative analysis of functional

group used in the analytical method development. It also covers the important aspects of

liquid and solid extraction procedure for bioanalytical samples.

Objectives

After the completion of the course, it is expected that the student shall be able to know

appropriate analytical skills required for the analytical method development.

principles of various reagents used in functional group analysis that renders necessary

support in research methodology and demonstrates its application in the practical

related problems.

THEORY 75 HOURS

1. Analytical principle, procedure and applications of the following reagents:

a) Ninhydrin b) 3-Methyl-2- benzthiazolinone hydrazone [MBTH] c) Folin –

Ciocaltau [FC] d) Para-dimethyl-amino benzaldehyde [PDAB] e) Para-dimethyl-

amino cinnamaldehyde [PDAC] f) 2, 6- Dichloroquinone chlorimide g) 1,2-

napthaquinone-4-sulfonate h) 2,3,5-Triphenyltetrazolium i) 2,4-Dinitro Phenyl

hydrazine [DNPH] j) Bratton – Marshall reagent k) 3,5- Dinitro salicylic acid

[DNSA]

10 Hrs

2. Calibration and validation of the following instruments used in pharmaceutical

industry:

a) HPLC b) HPTLC c) GC d) IR e) UV

07 Hrs

3. Principles and procedure involved in quantitative estimation of following functional

groups in drugs:

a) Hydroxyl b) Amine c) Carboxyl d) Carbonyl f) Ester g) Methoxyl

08 Hrs

4. Analytical Principle and procedure involved in the analysis of drugs containing the

following classes:

a). Alkaloids (Ephedrine, Reserpine and Ergotamine)

b). Glycosides (Digoxin and Strophanthin)

c). Antibiotics (Penicillin, Chloramphenicol and Erythromycin)

d). Steroids (Cholesterol, Progesterone and Androgen)

e). Vitamins (A, B1, B2, B12 and C)

10 Hrs

5. Analytical determination of the following elements:

a) Sodium b) Potassium c) Calcium d) Halogens e) Phosphorus e) Sulphur 08 Hrs

6. Biological tests and assays of the following:

a. Adsorbed Tetanus vaccine b. Adsorbed Diphtheria vaccine

c. Human anti haemophilic vaccine d. Rabies vaccine

e. Tetanus Anti toxin f. Tetanus Anti serum

g. Oxytocin h. Heparin sodium IP i. Antivenom

12 Hrs

7. General principle and procedure involved in the bio-analytical methods such as

Protein precipitation, Liquid - Liquid extraction and Solid phase extraction with

special emphasis on Therapeutic Drug Monitoring and Bioequivalence studies.

10 Hrs

8. Analytical principle and procedure involved in the assay of following methods with

special emphasize on official drugs in IP:

a) Complexometric titration b) Non aqueous titration c) Redox titration

d) Diazotization titration e) UV – Visible method f) HPLC

06 Hrs

9. Validation of water supply system with emphasis of demineralised water, distilled

water and water for injection. 04 Hrs

34

REFERENCES

1. Vogel‘s textbook of quantitative chemical analysis - Jeffery J Bassett, J. Mendham, R.

C. Denney, 5th


2. Practical Pharmaceutical Chemistry - Beckett and Stenlake, Vol II, 4th

Edition, CBS

publishers, New Delhi, 1997.

3. Textbook of Pharmaceutical Analysis - K A Connors, 3rd

Edition, John Wiley &

Sons, 1982.

4. Pharmaceutical Analysis - Higuchi, Brochmman and Hassen, 2nd

Edition, Wiley –

Inter science Publication, 1961.

5. Quantitative Analysis of Drugs in Pharmaceutical formulation – P D Sethi, 3rd

Edition, CBS Publishers New Delhi, 1997.

6. Pharmaceutical Analysis- Modern methods - J W Munson – Part B, Volume 11,

Marcel Dekker Series.

7. The Quantitative analysis of Drugs - D C Carratt, 3rd

edition, CBS Publishers,

NewDelhi, 1964.

8. Indian Pharmacopoeia Vol I , II & III 2006, 2010.

9. Methods of sampling and microbiological examination of water, first revision, BIS

10. Practical HPLC method development – Snyder, Kirkland, Glajch, 2nd

edition, John

Wiley & Sons.

11. Analytical Profiles of drug substances – Klaus Florey, Volume 1 – 20, Elsevier, 2005

12. Analytical Profiles of drug substances and Excipients – Harry G Brittan, Volume 21

– 30, Elsevier, 2005.

13. The analysis of drugs in biological fluids - Joseph Chamberlain, 2nd

edition, CRC

press, London.

Journals

1. Journal of Analytical Chemistry

2. Analytical Sciences

3. Talanta

Advanced Pharmaceutical Analysis (Practicals) 75 Hrs

1) Assay of official compounds by different titrations and instrumental techniques.

2) Calibration and validation of different analytical equipments like pH meter,

flourimeter, flame photometer, IR, UV and HPLC.

3) Quantitative determination of different functional groups.

4) Colorimetric determination of drugs by using different reagents.

35

PAPER - IV

Food and Cosmetic Analysis

Scope

This subject deals with the study of analysis of food and cosmetics by various

instrumental and chemical methods. This subject gives emphasis to various national and

international standards priscribed regarding food and cosmetic analysis.

Objectives At the end of the year studant is able to understand

Various chemical methods of analysis of food and cosmetics

Common adulterant and their analysis

Modern analytical rechniqued use in the analysis of food and cosmetics

Volunteer and mandatory National and International standards for food and cosmetics

THEORY 75 HRS

1. General analytical methods for the food constituents such as carbohydrates,

proteins and fats with special emphasis in the determination of moisture, ash,

nitrogen and physical constituents.

07 Hrs

2. General methods of analysis for oils and fats such as Iodine value,

Saponification value, Acid value, Rancidity and special tests for individual oils

like Arachis oil, sesame oil, sunflower oil, cotton seed oil, fish oil and fat

soluble vitamins.

08 Hrs

3. General Analytical methods for milk, milk constituents and milk products like

ice cream, milk powder, butter, margarine, cheese including adulterants and

contaminants of milk.

10 Hrs

4. Analysis of fermentation products like wine, spirits, beer and vinegar. 07 Hrs

5 Analysis of hazardous substances, trace elements and pesticides in food such as

volatile denaturants in alcoholic products, fluoride, lead, methanol, phenol,

cadmium, copper, nickel, iron, antimony, arsenic, mercury, organophosphorous

pesticides and organo chlorine pesticides.

10 Hrs

6 Legislation regulations of food products with special emphasis on BIS and

Agmark, US-FDA. 07 Hrs

7 General study of raw materials used in the cosmetic industry including quality

control tests.

08 Hrs

8 Safety legislation to cosmetic products and different toxicity tests for the

cosmetics. 08 Hrs

9 In process quality control tests and Indian standard specifications laid down for

sampling and testing of various cosmetics in finished forms such as baby care

powders, skin care products, dental products, personal hygiene preparations, lips

sticks, hair products and skin creams by the Bureau Indian Standards.

10 Hrs

36

REFERENCES

1. The chemical analysis of foods – David Pearson, Seventh edition,

Churchill Livingstone, Edinburgh London, 1976

2. Introduction to the Chemical analysis of foods – S. Nielsen, Jones &

Bartlett publishers, Boston London, 1994.

3. Official methods of analysis of AOAC International, sixth edition,

Volume I & II, 1997.

4. Analysis of Food constituents – Multon, Wiley VCH.

5. Indian Standard specification for various cosmetic preparations, BIS,

New Delhi.

6. Harry‘s Cosmeticology – Wilkinson, Moore, seventh edition, George

Godwin, 1982.

7. Dr.William Horwitz, Official methods of analysis of AOAC

International, 18th edition, 2005.

Food and Cosmetic Analysis (Practicals) 75 Hrs

1) Assay of food constituents by different titrations and instrumental methods

2) Estimation of food contaminants by different analytical methods

3) Quantitative determination of cosmetics

4) Quality control tests of cosmetics

37

M. Pharm - Pharmaceutical Biotechnology (MBT)

Paper Subject Code

I Bioinformatics and Computational

Biotechnology MBT01

II Microbial and Cellular Biology MBT02

III Bioprocess Technology MBT03

IV Advances in Pharmaceutical Biotechnology MBT04

38

Paper – I

Bioinformatics and Computational Biotechnology

Scope

This paper has been designed to provide the advanced knowledge to the biotechnology

students in invaluable areas of advanced bioinformatics which plays a crucial role in

determining its future use and applications in medicine, drug discovery and in pharmaceutical

industry.

Objective

Students will get an idea about the usage of insilico technique, tools and their uses in

drug discovery.

to study the genomic arrangement, its manipulation to useful products and to correct

the accidental manipulation to prevent the occurrence and the treatment of disease

related to genetic.

THEORY 75 HRS

1. Introduction To Bioinformatics: Definition and History of Bioinformatics,

Internet and Bioinformatics, Introduction to Data Mining, Applications of Data

Mining to Bioinformatics Problems and Applications of Bioinformatics.

Bioinformatics Software‘s: Clustal V, Clustal W 1.7, RasMol, Oligo,

Molscript, Treeview, Alscript, Genetic Analysis Software, Phylip.

Biocomputing: Introduction to String Matching Algorithms, Database Search

Techniques, Sequence Comparison and Alignment Techniques, Use of

Biochemical Scoring Matrices, Introduction to Graph Matching Algorithms,

Automated Genome Comparison and its Implication, Automated Gene

Prediction, Automated Identification of Bacterial Operons and Pathways;

Introduction to Signaling Pathways and Pathway Regulation. Markov chains

and applications: Machine Learning Methods, Hidden Markov models,

Applications of HMM in gene identification and Profiles HMMs, Neural

Networks and Support Vector machines.

15 Hrs

2. Databases: Nucleic Acid Sequences, Genomes, Protein Sequence and

Structures, Access to Molecular Biology Data Bases: Entrez, Sequence

Retrieval System (SRS), Protein Identification Resource (PIR)

10 Hrs

3. Analytical Techniques

Infrared Spectroscopy: Instrumentation and principles and working

associated with IR spectroscopy.

Nuclear magnetic resonance (NMR)- Principle, instrumentation and

workings of NMR and its applications

Mass Spectroscopy- Instrumentation, principle and its application , GC-MS,

LC-MS.

X ray Crystallography: Production of X rays, Different X ray methods,

Braggs law, Rotating crystal technique, X ray powder technique, Types of

crystals, Interpretation of diffraction patterns and applications of X-ray

diffraction.

Electrophoresis: Principle, Instrumentation, Working conditions, factors

affecting separation and applications of the following: a) Paper electrophoresis

b) Gel electrophoresis c) Capillary electrophoresis d) one electrophoresis e)

Moving boundary electrophoresis f) Iso electric focusing

ELISA: Working Principles, Instrumental designs, Tests, Kits

PCR: Working Principles, Instrumental designs, Tests, Kits

10 Hrs

39

Radioimmunoassay: Importance, various components, Principle, Different

methods, Limitation and Applications of Radio immuno assay

4. Genoinformatics Diversity of Genomes: Prokaryotic and Eukaryotic Genomes: Structure,

Organization, Gene Families. Genome Analysis: Introduction, Gene prediction

methods, Gene mapping and applications- Genetic and Physical Mapping,

Integrated map ; Sequence assembly and gene expression, Completed

Genomes: Bacterium, Nematode, Plant and Human, Evolution of Genome:

Lateral or Horizontal Transfer among Genomes, Transcriptome and Proteome-

General Account, Phylogenetic analysis: Evolutionary Change in Nucleotide

Sequences, Rates and Patterns of Nucleotide Substitution, Models for

Nucleotide Substitution and Methods for Phylogenetic analysis: Sequence

Alignment, Software‘s (SSearch, BLAST, FASTA, CLUSTAL), Construction

of Phylogenetic Tree, Genome Annotation- Introduction

15 Hrs

5. Prediction of Protein Structure and Modeling

Amino Acids, Peptides and Proteins: Structure of Proteins: Primary,

Secondary, Tertiary and Quaternary; Protein Folding; Structure-Conformation

Function relationship, Protein Secondary Structure Prediction Methods,

Statistical Methods of Chou and Fasman, Garnier-Osguthorpe-Robson,

Stereochemical Method of Lim and Neural Network Method, etc, Fold

Recognition and Threading Methods, Profiles, Motifs – Regular Expressions,

Position Specific Scoring Matrices, Repeat Finding and pattern Recognition,

Classification of Three Dimensional Structures of Proteins, Prediction of

Structural Classes, Motifs, Folds and Domains, Classification of Three

Dimensional Structures in Brookhaven Protein Data Bank (HSSP, SCOP,

FSSP, CATH). Protein Structure Prediction: Structural Alignment Methods,

Homology Modeling Dynamical Programming, Molecular Simulation,

Rational Drug design and Docking

15 Hrs

6. APPLICATIONS OF BIOINFORMATICS

Bioinformatics in pharmaceutical industries, Bioinformatics in

immunology, Bioinformatics in agriculture, Bioinformatics in forestry, and

Biosensing.

REFERENCES 1. Lesk, A.M. 2002 Introduction to Bioinformatics. Oxford University

Press.

2. Mont, D.W., Bioinformatics: Sequence and Genome Analysis

3. Letovsky, S.I. 1999 Bioinformatics. Kluwer Academic Publishers.

4. Baldi, P. and Brunak, S. 1998 Bioinformatics. The MIT Press.

5. Setubal, J. and Meidanis, J. 1996 Introduction to Computational

Molecular Biology. PWS Publishing Co., Boston.

6. Fogel, G.B. and Corne, D.W., Evolutionary Computation in

Bioinformatics

7. Evens, W.J. and Grant, G.R., Statistical Methods in Bioinformatics: An

Introduction.

8. Liu, B.H., Statistical Genomics: Linkage Mapping and QTL Analysis

9. Murray et. al., 2003 Harpers Illustrated Biochemistry. Prentice Hall Int.

10. Nelson, D.L. & Cox, M.M., 2004 Lehninger‘s Principles of

Biochemistry 4th Edition. Macmillan UK, Worth Publishers, USA.

10 Hrs

40

11. Berg, J.M., Tymoczko, J.L., Stryer, L., 2002 Biochemistry 5th Edition.

W.H. Freeman & Co. New York.

12. Date, C.J. An Introduction to Database Systems, Vol I & II. Addison

Wesley.

13. Ullman, J.D. Principles of Database Systems. Galgotia, New Delhi.

14. Wilkins, M.R., Williams, K.L., Appel, R.D., Hochstrasser, D.F.

(Editors) 1997 Proteome Research: New Frontiers in Functional

Genomics. Springer Verlag Berlin Heidelberg.

15. Baxevanis, A. and Ouellette, F.B.F (Editors) 1998 Bioinformatics: A

Practical Guide to the Analysis of Genes and Proteins. John Wiley and

Sons, New York.

16. Dale and Schartz 2003 From Genes to Genomes. Humana.

17. Hawley and Mori 1999 The Human Genome. Academic.

18. Primrose and Twyman 2003 Principles of Genome Analysis &

Genomics. Blackwell.

19. Jerome, P.E. 2002 Mathematics for Genome Analysis. Cambridge.

20. Wilkins, M.R., Williams, K.L., Appel, R.D., Hochstrasser, D.F.

(Editors) 1997 Proteome Research: New Frontiers in Functional

Genomics. Springer Verlag Berlin Heidelberg.

21. Baxevanis, A.D. and Francis Ouellette, B.F. 2004 Bioinformatics: A

Practical Guide to the Analysis of Genes and Proteins. Second Edition,

Wiley.

22. Graur, D. and Li, W-H. 2000 Fundamentals of Molecular Evolution.

Sinauer Ass., USA.

23. Tisdall, D., 2003 Mastering Perl for Bioinformatics. O‘Reilly.

24. Jan Drenth Principles of Protein X-ray Crystallography (Springer

Advanced Texts in Chemistry), Springer-VerlagTelos.

25. Bovey, F,A., Mirau, P.A. and Gutowsky, H.S., Nuclear Magnetic

Resonance Spectroscopy (2nd Edition). Academic Press.

26. Gasteiger, 2003 Chemoinformatics A Text Book.

27. Lengauer, T. et. al. 2001 Bioinformatics: From Genomes to Drugs.

Wiley-VCH.

28. Tudor, I.O., Mannhold, R. Kubinyi, H. and Folkers, G. Chemo

Informatics in Drug Discovery (Methods and Principles in Medicinal

Chemistry.

29. Jensen, F. Introduction to Computational Chemistry. John Wiley &

Sons.

30. Instrumental methods of analysis – Willards, 7th edition, CBS

publishers.


Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.

32. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.

41

Bioinformatics and Computational Biotechnology (Practical) 75Hrs

1. Exploring the ExPASy sites and write information received in your record.

2. retrieving metabolic pathways using KEGG PATHWAY Database

3. retrieving metabolic pathways using Reactom

4. Retrieving Protein and DNA Sequences using Entrez at NCBI

5. Retrieving Protein and DNA Sequences using SRS at EBI

6. Web browsing at SwisProt

7. Web browsing at PIR PSD

8. Web browsing at UniProtKB

9. Nucleotide BLAST – Search nucleotide database using nucleotide query

10. Protein BLAST – Search Protein database using protein query

11. Multiple Sequence Alignment – CLUSTALW

12. ProtParam - Physico-chemical parameters of a protein sequence (amino-acid and

atomic compositions, isoelectric point, extinction coefficient, etc.)

13. Molecular Weight (Mw) from a UniProt Knowledgebase entry or for a user sequence

14. ScanSitepI/Mw - Compute the theoretical pI and Mw, and multiple hosphorylation

states

15. Use visualization tools like Swiss-PdbViewer, Jmol, MolMol, PyMol, Rasmol, VMD

16. Download protein and DNA from PDB and display using above programs and analyze

the structural features

17. APSSP - Advanced Protein Secondary Structure Prediction Server

18. GOR - The GOR (Garnier-Osguthorpe-Robson) method uses both information theory

and Bayesian statistics for predicting the secondary structure of protein.

19. Homology modeling - SWISS-MODEL - An automated knowledge-based protein

modelling server

20. Threading - Phyre (Successor of 3D-PSSM) - The PHYRE automatic fold recognition

server for predicting the structure and/or function of your protein sequence

21. Ab initio - HMMSTR - Prediction of protein structure from sequence Assessing

tertiary structure prediction

22. PROCHECK - Verification of the stereochemical quality of a protein structure

23. What If - Protein structure analysis program for mutant prediction, structure

verification, molecular graphics

42

Paper-II

Microbial and Cellular Biology

Scope

This paper has been designed to provide the advanced knowledge to the

biotechnology students in invaluable areas of advanced microbiology which plays a crucial

role in determining its future use and applications in medicine, drug discovery and in

pharmaceutical industry.

Objective

Students will get an idea about the usage of microbiological technique, tools and their

uses in drug discovery in respect of cellular and molecular aspect.

THEORY 75 HRS

1. Microbiology Introduction – Prokaryotes and Eukaryotes Bacteria, fungi and

virus, structure, chemistry and morphology, cultural, physiological and

reproductive features. Methods of isolation, cultivation and maintenance,

nomenclature, general classification, molecular and genotypic taxonomy.

Nutrition and Growth.

10 Hrs

2. Bioenergetics Basic aspects of cell regulation Bioenergetics and metabolism-

biochemical mechanisms of generating ATP, fuelling reactions of aerobic and

anaerobic organisms, Production of secondary metabolites and its applications.

12 Hrs

3. Molecular Genetics Structure – Replication – synthesis and types of DNA and

RNA Transcription, translation, Genetic code. 08Hrs

4. Microbial Genetics: Genetic organization of prokaryotes and eukaryotic cells,

mutagenesis and repair mechanisms, types of mutants, application of mutagenesis

in stain improvement, gene mapping of plasmids- types purification and

application Transformation, conjugation and transduction, Phage genetics-

genetic organization, phage mutation and lysogeny.

10 Hrs

5. Animal Biotechnology Growth of Microorganisms in culture pertaining in

bacteria, principles of microbial nutrition, physical and chemical environment for

microbial growth, batch continuous and synchronous cultures. Stability and

degeneration of microbial cultures. Growth of animal cells in culture, general

procedure for cell culture, Nutrient composition, Primary, established and

transformed cell cultures, applications of cell cultures in pharmaceutical industry

and research. Growth of viruses in cell culture propagation and enumeration In

vitro screening techniques- anti-tumor, anti-viral, cytotoxicity

15 Hrs

6. Immunology Cellular basis of immune response, immunity to viruses, bacteria

and fungi, immuno deficiency disease – hypersensitivity reactions, auto immune

disease – immunization- active and passive.

10 Hrs

7. Pathogenesis and Chemotherapy identifying the features of pathogenic

bacteria, virus and fungi. Mechanism of microbial pathogenicity, etiology and

pathology of common microbial diseases, currently recommended therapy for

common bacterial, fungal and viral infections, mechanism of action of

antimicrobial agents and possible sites of chemotherapy.

10 Hrs

43

REFERENCES 1. Molecular Biology by Freifeider

2. Culture of animal cells – A manual of Basic techniques by R. Ian

Freshney

3. General Microbiology by R.Y Stainer

4. Essential and application of microbiology by Judy Kandal.

5. Microbiology by pelczar, Reid and Chan.

6. Microbial genetics – David Freifeider.

7. Immunology by Weir

8. Immunology by ivanRoitt, David male.

9. Medicinal Microbiology by Mackie and McCartney.

10. Principles of Gene maupulating- RW Old and Primrose.

11. Molecular cell biology by David Baltimore

12. Therapeutic peptide and proteins; formulation, processing and delivery

systems by Ajay K. Danga.

13. Cell biology vol-I,II,III by Julio E.Cells

Microbial and Cellular Biology (Practical) 75Hrs 1. Fumigation of the laboratory

2. Isolation and Purification of microorganism from the soil

3. Water analysis

4. Determination of Minimum Inhibitory concentration by gradient plate technique

5. UV- survival curve.

6. Dark repair

7. Determination of Minimum inhibitory concentration by serial dilution method.

8. Production of Pigment

9. Sterility test for injectable preparations

10. Estimation of microbial load

11. Bacterial endotoxin test.(Lal test)

12. Animal Tissue culture

13. Subculture/ Transfer/Passaging

14. Cell counting

15. Cytotoxic assay.

44

Paper - III

Bioprocess Technology

Scope


students in invaluable areas of advanced bioprocess technology areas which plays a crucial

role in determining its future use and applications in medicine, drug discovery and in


Objective

At completion of this course it is expected that students will be able to –

get an idea about the usage of Bioprocess technique, tools and their uses in drug

discovery.

to study the Bioprocessing areas, its manipulation to useful products and to correct

the accidental manipulation to prevent the occurrence and the treatment of disease

related to process and industrial productions..

THEORY 75 HRS

1. Introduction to fermentation processes

a) Basic principles of fermentation

b) Detailed study of the design and operation of bioreactor, ancillary parts

and function, impeller design and agitation, power requirements on

measurements and control of dissolved oxygen, carbon dioxide,

temperature, pH and foam

c) Types of bioreactor - CSTR, tower, airlift, bubble column, packed glass

bead, hollow fiber, configuration and application

d) Computer control of fermentation process: system configuration and

application

12 Hrs

2. Mass transfer and Rheology

a) Mass transfer - theory, diffusional resistance to oxygen requirements of

microorganisms, measurements of mass transfer coefficient and factor

affecting them, effects of aeration and agitation on mass transfer, supply

of air, air compressing, cleaning and sterilization of air and plenum

ventilation, air sampling and testing standards for air purity

b) Rheological properties of fermentation system and their importance in

bioprocessing

12 Hrs

3. Microbial growth kinetics

Reaction kinetics, michaelis - menten constant and monod equation-

derivation for biomass estimation, lineweaver - burke plot, thermal death

kinetics

05 Hrs

4 Cultivation and immobilized culture system

Cultivation system - batch culture, continuous culture, fed batch culture.

Graphical plot representing the above systems.

a) Introduction to immobilization, techniques, immobilization of whole

cell, use of immobilized culture system to prepare fine chemicals.

12 Hrs

5 Scale up of fermentation process

Principles, theoretical considerations, techniques used, media for

fermentation, HTST sterilization, advantage and disadvantage, liquid

sterilization.

10 Hrs

45

6. Scale down of fermentation process

Theory, equipment design and operation, methods of filtration, solvent

extraction, chromatographic separation, crystallization turbidity analysis

and cell yield determination, metabolic response assay, enzymatic assay,

bio autographic techniques and disruption of cells for product recovery.

a) Isolation, screening: primary and secondary, maintenance of stock

culture, strain improvement for increased yield.

b) Actinomyces - methods of isolation, cultivation and maintenance,

nomenclature, general classification, molecular and genotypic

taxonomy and application of industrially important microbes.

12Hrs

7 i) Bioprocessing of the following industrially important microbial

metabolites Organic solvents - Alcohol, Glycerol and acetone-butanol

a. Organic acids - Citric acids, Lactic acids, Itaconic acid, acetic

acid and Gluconic acid

b. Antibiotics - Penicillin, Streptomycin, Griseofulvin,

Cephalosporins,

c. Amphotercin B, Rifampicin, Mitimycin C and Tetracyclines

d. Vitamins - Vit - B12, Riboflavin and Vit C

e. Amino acids - Glutamic acids, Lysine, Cyclic AMP and GMP

ii) Biosynthetic pathways for some secondary metabolites, microbial

transformation of steroids and alkaloids

10 Hrs

8 Regulation governing the manufacturing of biological products

REFERENCES 1. Principles of fermentation technology by Peter F. Stanbury, Allan

Whitaker, Stephen J. Hall

2. Industrial microbiology by I. F. Casida

3. Industrial microbiology by B. M. Miller and W. Liteky

4. Microbial technology, volume I and II by H. Peppler

5. Industrial biotechnology by Vedpal S. Malik and Padma Sridhar

6. Biochemistry of industrial microorganisms by C. Rainbow and Rose

7. Biochemical engineering by F.C. Webb

8. Biochemical engineering by R. Steel

9. Biochemical engineering fundamentals by Balley and Ollis

10. Current protocols in molecular biology, volume I and II by F.M.

Asubel, John Wiley Publishers

11. Biotechnology of antibiotics and other bioactive microbial

metabolites by CianearioLancini and Rolando Lorenzetti

12. Biological reaction engineering by I.J. Dunn, E. Heinzle, J. Ingham,

J.E. Prenosil

13. Bioreactor design and product yield by Butterworth and Helhemann

14. Enzyme assays - a practical approach by Robert Elsenthal and

Michael J. damson

15. Fermentation and biochemical engineering handbook by Henry C.

Vogel

16. Industrial microbiology by A. H. Patel

02 Hrs

46

Bioprocess Technology (Practicals) 75Hrs

1. Isolation and secondary screening of industrially important microorganisms

2. Strain improvement for increased yield by stress inducers

3. Preparation, calibration and standardization of bioreactor

4. Power calculations, KLa determinations and MTR calculations of a typical bioprocess

5. Construction of growth curve and determination of specific growth rate and doubling

time

6. Biomass estimation by monitoring protein synthesis and sugar depletion

7. Isolation and purification of extra cellular enzyme by

a. Precipitation- Acetone, ethanol and ammonium sulphate

b. Dialysis

c. Column chromatography.

8. Enzyme kinetic study

a. Effect of metal ion concentration

b. Effect of pH

c. Effect of temperature

d. Effect of varying substrate concentration

e. Kinetic parameter calculations

9. Protein separation by aqueous two- phase partitioning

10. Fermentation process of alcohol and wine production

11. Fermentation of vitamins and antibiotics

12. Whole cell immobilization engineering

a. Using various polymer

b. Study of physical characteristics

c. Comparison of efficacy of immobilized and free cells

13. Scale down processing

a. Methods of cell disruption

b. Typical isolation process for antibiotics

c. Purification by chromatographic techniques

14. Microbiological assay of antibiotics

15. Thermal death kinetics of bacteria and its applications

47

Paper - IV

Advances in Pharmaceutical Biotechnology

Scope


students in invaluable areas of advanced areas in Pharmaceutical biotechnology which plays a

crucial role in determining its future use and applications in medicine, drug discovery and in


Objective

At completion of this course it is expected that students will be able to –

get an idea about the latest technology development in biotechnology technique, tools

and their uses in drug and vaccine development.

to study the Enzymetic, DNA sequencing, gene therapy areas to useful products and

to correct the gene manipulation to prevent the occurrence and the treatment of

disease related to diseases.

THEORY 75Hrs

1. Enzymology Introduction, Classification, Source, Extraction, Purification, Enzyme

specificity, Enzyme catalysis Industrial applications

05 Hrs

2. Recombinant DNA Technology Introduction: Cutting and Joining of DNA molecules, Genetic engineering

techniques of Gene manipulation, chemical synthesis of DNA, analysis of DNA

sequences, whole genome sequencing, site directed mutagenesis. Signal

transduction, oncogenes and their proteins. Application of genetic engineering

in the production of regulatory protein like interferon, Erythropoietin, Hepatitis-

B and Insulin

10 Hrs

3. Gene Biology a. Importance of Gene cloning- the early development of genetics –the advent

of gene cloning- specialized tools and techniques- impact or recombinant

DNA techniques on research and biotechnology

b. Vehicles – Plasmids, Cosmid, Plasmids, Bacteriophage and other advanced

vectors.

c. Purification of DNA from living cells- preparation of total DNA Plasmid

DNA-preparation of Bacteriophage DNA

d. Manipulation of purified DNA- the range of DNA manipulative enzymes-

Enzymes for cutting DNA- restriction endonucleases-Ligation- Joining of

DNA molecules together

e. Introduction of DNA into living cells-Transformation – the Uptake of

DNA by the bacterial cells- Identification of recombinant- Introduction of

phage DNA into bacterial cells.

f. Cloning vectors for E. Coli- Based on E.Coli Plasmids- M13

Bacteriophage- λ-Bacteriophage- other high capacity vectors enable

genomic libraries to be constructed- vectors for other organisms other then

E. Coli

10 Hrs

4. Application of cloning in gene analysis a. Obtaining a clone of specific gene –the Problem of selection- Direct

selection-Identification of clone from a gene library- Methods for clone

identification.

10 Hrs

48

b. Studying of gene and genome structure- study about the location of the

cloned gene – Working out the structure of gene- study of genome

structure using cloned gene.

c. Studying of gene expression- Lacoperon –TrpOperon—Transcriptional

regulations by alternative σ factors

d. The Polymerase chain reaction- and its application – Molecular markers-

RFLP (Restriction Fragment Length Polymorphism) Random amplified

polymeric DNA (RAPDs). Blotting techniques.

5. Gene cloning in research and Biotechnology

a. Production of proteins from the cloned genes- Special vectors for

expression of foreign genes in E. coli- General problems with the

production of recombinant protein in E. coli- production of recombinant

protein by eukaryotic cells.

b. Gene cloning in medicine – Production of recombinant pharmaceuticals-

Identification of genes responsible for the human disease – gene therapy.

c. Synthesis of commercial products by recombinant microorganisms –

synthesis of amino acids- removal of lipids- cloning antibiotic biosynthesis

gene- synthesis of novalnatibiotica and peptide antibiotics- biopolymer

such as Xanthan gum production, animal adhesive biopolymer-

polyhydroxyalkonates

10 Hrs

6. Gene transfer to animal cell

Introduction, DNA medicated transformation, Gene transfer by viral

transduction, summary of expression systems for animal cells, Genetic

manipulation of mammals, DNA transfer to other vertebrates.

05 Hrs

7. Human Molecular Genetics:

Modes of human inheritance- Genetic linkage and Gene mapping- Detection

and estimation of genetic linkage in humans- genetic mapping of Human

chromosomes, genetic polymorphism- comprehensive human linkage maps

mapping of genetic disease locus to a chromosome location- whole genome

BAC map- radiation hybrid mapping- Human Genome sequence- detection of

mutation in human genes- single strand conformational analysis- hetero

duplex analysis- chemical mismatch cleavage- direct DNA sequencing and

determining the gene function

10 Hrs

8. Transgenic animals

Transgenic mice- methodology- retroviral vector method- DNA micro

injection method- Engineered stem cell method, Genetic modification with the

Cre-Lox P recombinant system- transgeneis with high capacity vectors- its

application model for Alzheimer disease – as a test system- conditional

regulation of Gene expression and cell death

05 Hrs

9. Bioremediation and Biomass Utilization

Microbial Degradation of Xenobiotics, Genetic engineering of Biodegradative

pathways- Manipulation of transfer plasmids- Manipulation by gene

alterations- Utilization of starch and sugars- Utilization of cellulose.- Isolation

of Prokaryotic and Eukaryotic cellulose gene and manipulation of cellulose

gene.

05 Hrs

10. Immuno Biotechnology

Hybridoma technology, Fusion methods for Myloma cells and B-

Lymphocytes, selection and screening techniques. Production and

purification of Monoclonal antibodies and their applications in clinical

diagnosis, Immunotherapy and pharmaceutical research. Immuno diagnosis

of infectious diseases Vaccinology- immuno potentiation, adjuvants, living

05 Hrs

49

and non- living antigen, newer delivery system and naked DNA vaccines.

New and improved vaccines against Hepatitis A, Malaria, Typhoid,

Experimental HIV-I vaccines,

REFERENCES 1. Instant notes in molecular biology- by P.C. Turner, A.G. Mclennan A.D Bates and

M.R.H. White

2. Molecular Biotechnology, Principles and applications or Recombinant DNA by

Bernard R.Glick, Jack J. Pasternak.

3. Gene cloning an Introduction by T.A Brown

4. Genomes by T.A Brown

5. Principles of rDNA technology by Old M. Primrose.

6. Bio informatics, Gene, Proteins and computers by C.A orengi, D.T.Jones and J.M.

Thornton

7. Genetics analysis of Genes and Genomes- Jones and Bartlett

8. Molecular genetics, an introductory narrative – Richard calendar

9. Molecular biology and biotechnology – by J.M. Walker and E.B. Gingold

10. Biotechnology – U. Satyanarayana

11. Biotechnology – Purohit and Mathur

12. Biotechnologby B.D. Singh

13. Pharmaceutical biotechnology by Muller

14. Molecular biology of cell – Watson, Hopkins , Steitz, Weiner

Advances in Pharmaceutical Biotechnology (Practicals) 75Hrs 1. Replica plating.

2. Bio-autography.

3. Isolation and estimation of DNA.

4. Recovery of DNA fragments.

5. Agarose gel electrophoresis.

6. Isolation and estimation of RNA.

7. Isolation of plasmids

8. Isolation of extra cellular proteins and its estimation.

9. Restriction of DNA

10. Ligation

11. Isolation of Bacteriophage

12. Transformation

13. SDS – polyacrylamide gel electrophoresis for proteins

14. Silver staining

15. Polymerase chain reaction technique.

16. Determination of MIC by Gradient plate techniques.

17. Purification of enzymes by ammonium sulphate precipitation, dialysis, and column

chromatography.

18. Western Blotting

19. Immunoelectrophoresis

20. Immunoglobulin purification

51

M. Pharm- Pharmaceutical Chemistry (MPC)

Paper Subject Code


II Advanced Organic Chemistry MPC02

III Advanced Medicinal Chemistry MPC03

IV Natural Products of Medicinal Interest MPC04

52

PAPER - I


Scope




Objectives





THEORY 75 HRS


associated with UV-Visible spectroscopy, Choice of solvents and solvent effect,



06 Hrs








spectroscopy

08 Hrs


Instrumentation, Solvent requirement in NMR, Relaxation process, NMR signals

in various compounds, Chemical shift, Factors influencing chemical shift, Spin-

Spin coupling, Coupling constant, Nuclear magnetic double resonance, Brief

outline of principles of FT-NMR with reference to 13

CNMR: Spin spin and spin

lattice relaxation phenomenon. 13



14 Hrs




rules, Fragmentation of important functional groups like alcohols, amines,

carbonyl groups and alkanes, Meta stable ions, Mc Lafferty rearrangement, Ring

rule, Isotopic peaks, Tandem Mass Instruments, Interpretation and Applications of

Mass spectroscopy.

10 Hrs









10 Hrs

53





06 Hrs




03 Hrs










REFERENCES

1. Spectrometric Identification of Organic compounds - Robert M Silverstein,












edition, CBS Publishers, New Delhi, 1997.



8. Quantitative analysis of Pharmaceutical formulations by HPTLC - P D

Sethi, CBS Publishers, New Delhi.


Edition,

Wiley – Interscience Publications, 1961.

10. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi,

3rd


11. Pharmaceutical Analysis- Modern methods – Part B - J W Munson,

Volume 11, Marcel Dekker Series


Elsevier, 2005



Journals:


2. Indian Drugs





04 Hrs

54

Modern Analytical Techniques (Practicals) 75Hrs















55

PAPER II

Organic Chemistry

Scope The subject is designed to provide detail information about advances in Organic chemistry

and Different techniques of organic synthesis and their application to medicinal chemistry.

Objective

Upon completion of course, the student shell be able to

understand the principle and applications of stereochemistry & chiral drugs synthesis

know the concept of Green Chemistry & combinatorial synthesis.

understand the mechanism behind the various named reactions

apply the concept of disconnection approach to develop synthetic route for small

target molecule.

THEORY 75 Hrs

1 Basic Aspects of Organic Chemistry

a) Organic intermediates: carbocations, carbanions, free radicals, carbenes and

nitrenes. Formation, stability and synthetic applications of organic

intermediates

b) Various types of reaction mechanisms and methods of determining them.

08 Hrs

2 Study of reaction mechanisms, relative reactivity and orientations.

a. Substitution reactions: aliphatic nucleophilic (SN1 and SN2), aromatic

electrophilic, aliphatic electrophilic, aromatic nucleophilic and free radical

substitions.

b. Addition reactions (across both carbon-carbon and carbon-heteroatom

multiple bonds).

c. Elimination reactions (E1,E2 and Hoffman Saytzeff‘s)

d. Rearrangement reactions. Type of rearrangement reactions. Mechanism of

Pinacol rearrangements, Benzilic acid Rearrangement, Beckman

rearrangement, Hoffmann rearrangement.

e. Rearrangement reactions.

f. Oxidation – reduction reactions and the reagents used for such reactions.

g. Protection and deprotection of various groups.

12 Hrs

3 Stereochemistry

a. Chirality and the importance of chiral drugs.

b. Methods of asymmetric synthesis, enantiopure separation and Stereo

selective synthesis with examples

c. Symphoria: Introduction, neighbouring group effects with reference to

stereo chemistry, intra molecular neucleophilic attack, rate of reaction,

anchimeric assistance.

06 Hrs

4 Synthetic methodologies for obtaining drugs

a) Introduction to Disconnection approach

b) Selective functional group interconversions (FGI) with examples.

c) Retrosynthetic analysis of some drugs.

08 Hrs

5 Heterocyclic Chemistry

General methods of synthesis of five, six membered and fused heterocylces

such as imidazole, pyrazole, triazole, pyrimidine, quinoline, acridine,

phenothiazine and purine. Study of synthesis of few representative drugs

containing these heterocyclic moieties.

08 Hrs

56

6 Photochemical Reactions

Basic principles of photochemical reactions. Photo-oxidation, photo-addition,

photo rearrangements and photo-fragmentation.

05 Hrs

7 Phase Transfer Catalysis

General principles of phase transfer catalysis. Types of PT catalysts with

examples. Synthetic applications of PTC

05 Hrs

8 Pericyclic reactions

Mechanism, Types of pericyclic reactions such as cyclo addition, elctrocyclic

reaction and sigmatrophic rearrangement reactions with examples.

05 Hrs

9 Study of the following reactions with reference to their mechanisms and

synthetic applications

a. Birch reduction.

b. Mannich reaction.

c. Meerwin-Pondroff‘s reduction.

d. Oppeneaur oxidation.

e. Wolf Kishner reduction.

f. Grignard reaction.

g. Diel‘s alder reaction.

h. Perkin Reaction.

i. Reformatsky reaction.

j. Michael reaction.

10 Hrs

10 Introduction to the combinatorial chemistry

Introduction, development, techniques like solid support and solution phase

synthesis and applications of combinatorial synthesis

04 Hrs

11 Microwave irradiated organic synthesis

Introduction, instrumentation, synthetic application and limitations

04 Hrs

REFERENCES

1. ―Advanced Organic chemistry, Reaction, mechanisms and structure‖, J. march, John

Wiley and sons, New York.

2. ―Mechanism and structure in organic chemistry‖, E.S.Gould, Hold Rinchart and

Winston,NewYork.

3. ―The Organic Chemistry of Drug Design and Action‖ R.B.Silverman, Academic press

Inc., San Diego, 1992.

4. ―Chitotechnology‖ R.A. Steldon, Marcell Dekker Inc., Newyork 1993.

5. ―Asymmetric synthesis‖, R.A. Aitken and S.M.Kilengi, Ed., Blackie Academic and

professional London, 1992.

6. ―Organic Chemistry‖ Clayden, Greeves, Warren and Woihers., Oxford University

Press 2001.

7. ―Organic Chemistry‖ Vol I and II. I.L. Finar. ELBS, Sixth ed., 1995.

8. A guide to mechanisms in Organic Chemistry – Peterskyes (Orient Longman, New

Delhi).

9. Reactive intermediates in organic chemistry – Tandom and Gowel.

10. Molecular reaction and Photochemistry – C.H. Depuy and O.L.Chapman.

11. Combinational Chemistry – Synthesis and applications – Stephen R. Wilson

&Anthony W. Czarnik.

12. A. Carey, Organic chemistry, 5th edition (Viva Books Pvt. Ltd.)

13. Organic synthesis-the disconnection approach, S. Warren, Wily India

14. Principles of organic synthesis, R.O.C.Norman and J.M.Coxan, Nelson thorns

57

Organic Chemistry (Practicals) 75Hrs

1. Synthesis of Heterocyclic compounds Compounds containing five membered, six membered and Fused ring – (Each two)

2. To perform the following reactions of synthetic importance

a) Any two reduction reaction

b) Any one Oxidation reaction

c) Any two rearrangement reaction

d) Any two Named reaction

e) Photo chemical reaction.

3. To perform the Microwave irradiated reactions of synthetic importance (Any

two)

58

PAPER- III

Medicinal Chemistry and Drug Design

Scope The subject is designed to impart knowledge about recent advances in the field of medicinal

chemistry at the molecular level including different techniques for the rational drug design

and synthesis.

Objective

Upon completion of course, the student shell be able to

understand various strategies to design and develop new drug like molecules

understand the strategies of scale up of APIs

work with simple molecular modelling softwares to design drugs

understand the in silico and in vitro screening techniques

understand IPR issues related to the drug discovery and development

THEORY 75 HOURS

1 Quantitative analysis of Structure Activity Relationship

a. History and development of QSAR.

b. Physicochemical parameters.

c. Hansch analysis, Fee Wilson analysis, relationship between them.

d. Statistical methods – regression analysis, partial least square analysis

(PLS) and other multivariate statistical methods.

e. 3D QSAR approaches

10 Hrs

2 Molecular Modeling in Drug Design

a. Molecular Mechanics and quantum mechanisms.

b. Energy Minimization Methods

c. Conformational Analysis

d. Molecular docking and drug receptor interaction

e. De novo drug design

f. In silico drug design and virtual screening techniques- Molecular similarity

methods, Druglikeness screening, Pharmacophore screening.

11 Hrs

3 Stereochemistry and Drug action

Realization that stereo selectivity is a pre-requisite for evolution. Role of

chirality in selective and specific therapeutic agents. Case studies, Enantio

selectivity in drug adsorption, metabolism, distribution and elimination.

08 Hrs

4 Analog Design from Lead Molecule

Introduction, Bioisosteric replacement, rigid analogs, alteration of chain

branching, changes in ring size, ring position isomers, design of stereo isomers

and geometric isomers, fragments of a lead molecule, variation in inter atomic

distance.

08 Hrs

5 Prodrug Design

Basic concept, Prodrugs of functional group, Prodrugs to improve patient

acceptability, Drug solubility, Drug absorption and distribution, site specific

drug delivery and sustained drug action. Rationale of prodrug design and

practical consideration of prodrug design.

06 Hrs

6 Approaches to the Rational Design of Enzyme Inhibitors

Enzyme inhibitors in medicine, Enzyme inhibitors in basic research, rational

design of non-covalently and covalently binding enzyme inhibitors.

08 Hrs

7 Combating drug resistance

Causes for drug resistance, strategies to combat drug resistance in antibiotics and

anticancer therapy.

03 Hrs

59

8 Large Scale manufacturing

Introduction, Synthetic strategy, Stages of scale up process-bench, pilot and

large scale process. In-process control and validation of large scale process.

06 Hrs

9 In vitro screening procedures involving the following vital organs:

Heart for Autoradiographic localization of Angiotension converting enzymes.

Brain for Histamine receptor binding.

Kidney for Isolated perfused kidney.

Liver for Isolated perfused liver.

05 Hrs

10 Study the Polymorphism of APIs

Principle and general methods of Preparation of polymorphs, hydrates, solvates

and amorphous APIs, with special emphasis on Chloramphenicol palmitate,

Penicillin G, Cortisone acetate, Theophylline-Ethylenediamine salt and

Ampicillin.

05 Hrs

11 Intellectual Property Rights

Concept of IPR, Scope and nature of patents, Patentability, Patent Applications.

Commercialization and Licensing, Abbreviated New Drug Application (ANDA)

and Investigational New Drug Application (INDA).

05 Hrs

REFERENCES: 1. Medicinal Chemistry by Burger, 6

th edition, Vol I – IV.

2. Wilson and Gisvold‘s Text book of Organic Medicinal and Pharmaceutical Chemistry.

3. Comprehensive Medicinal Chemistry – Corwin and Hansch.

4. Computational and structural approaches to drug design edited by Robert M Stroud and

Janet. F Moore

5. Introduction to Quantitative Drug Design by Y.C. Martin.

6. Principles of Medicinal Chemistry by William Foye.

7. Drug Design Volumes by Arienes.

8. Principles of Drug Design by Smith.

9. The Organic Chemistry of the Drug Design and Drug action by Richard B.Silverman.

10. An Introduction to Medicinal Chemistry –Graham L.Patrick, (III Edition.)

11. Biopharmaceutics and pharmacokinetics by DM.Brahmankar, Sunil B .Jaiswal.

12. Pharmaceutical Manufacturing Encyclopedia, Two Volumes.

13. Drug Discovery & Evaluation, Pharmacological Assays, by Hans Gerhard Vogel, Two

Volumes (III Edition)

14. Polymorphism in Pharmaceutical Solids .Dekker Series Volume 95 Ed:HG

Brittain(1999)

Medicinal Chemistry and Drug Design (Practical) 75 Hrs

1. Synthesis of medicinally important compounds involving more than one steps along

with purification and Characterization using TLC, melting point and IR spectroscopy

(10 experiments)

2. Determination of partition coefficient of drugs

3. Determination of log P, MR, hydrogen bond donors and acceptors of selected drugs

using softwares (3 experiments)

4. Iin vitro screening of medicinally important compounds for antioxidant, antimicrobial,

DNA binding study (03 experiments)

5. In silico QSAR based experiments (5 experiments)

6. Preparation of polymorphs for two drugs (2 experiments)

60

PAPER - IV

Chemistry of Natural Products

Scope The subject is designed to provide detail knowledge about chemistry of medicinal compounds

from natural origin and general methods of structural elucidation of such compounds. It also

emphasizes on isolation, purification and characterization of medicinal compounds from

natural origin.

Objectives

Upon completion of course, the student shall be able to understand

different types of natural compounds and their chemistry and medicinal importance

the importance of natural compounds as lead molecules for new drug discovery

the concept of rDNA technology tool for new drug discovery

general methods of structural elucidation of compounds of natural origin

and isolate, purify and characterize simple chemical constituents from natural source

THEORY 75 HOURS

1 Study of Natural products as leads for new pharmaceuticals for the following

class of drugs:

a. Drugs Affecting the Central Nervous System: Morphine Alkaloids

b. Anticancer Drugs: Paclitaxel and Docetaxel, Etoposide, and Teniposide

c. Cardiovascular Drugs: Lovastatin, Teprotide and Dicoumarol

d. Neuromuscular Blocking Drugs: Curare alkaloids

e. Antiasthma Drugs: Khellin and Sodium Cromoglycate, Ephedrine

f. Antiparasitic Drugs: Artemisinin, Quinine.

12 Hrs

2 Alkaloids- General introduction, classification, isolation and purification of alkaloids,

general methods of structural determination of alkaloids, structural elucidation of

ephedrine and morphine

08 Hrs

3 Steroids- General introduction, chemistry of sterols, sapogenin and cardiac glycosides.

Stereochemistry and nomenclature of steroids, Structure elucidation of cholesterol

07 Hrs

4 Flavonoids. Introduction, isolation, purification of flavonoids. General methods of

structural determination of flavonoids.Structural elucidation of quercetin.

04 Hrs

5 Terpenoids – Classification, isolation, isoprene rule and general methods of structural

elucidation of Terpenoids. Structural elucidation of Menthol

04 Hrs

6 Coumarins – Chemistry, general methods of isolation, purification, and general

methods of structural Determination of coumarins

03 Hrs

7 Steroidal hormones:

Steroid sex hormones, natural and currently used synthetic derivatives, SAR;

Transformation of phytosterols into steroidal drugs.

06 Hrs

8 Recombinant DNA technology and drug discovery. Cloning of DNA, expression of cloned DNA, manipulation of DNA sequence

Information, new biological targets for drug developments, New pharmaceuticals

derived from biotechnology. Oligonucleotide therapy. Gene therapy: Introduction,

Clinical application and recent advances in gene therapy.

08 Hrs

9 β – Lactam antibiotics

Development and Mechanism of action of Beta Lactam antibiotics: Penicillins,

cephalosporins, Beta lactamase inhibitors, monobactums, carbapenams.

07 Hrs

10 Non β -Lactam antibiotics

Development and Mechanism of action of Amino glycosides, macrolides, lincomycins

and polypeptide antibiotics

04 Hrs

61

11 Isolation and characterization of natural Products

Isolation and separation of plants constituents using of HPLC, HPTLC and counter

current distribution. Structural determination of natural compounds using IR, 1HNMR,

MS Spectroscopy.

06 Hrs

12 Study of the active constituent of certain crude drugs used in Indigenous system.

a. Diabetic therapy – Gymnema sylvestre, Salacia reticulate, Pterocarpus

marsupiam, Swertia Chirata, Trigonella Foenum – graccum.

b. Liver dysfunction – phyllanthus niruri.

c. c. Antitumor – curcuma longa Linn.

REFERENCES

1. Modern methods of plant analysis – Peech and M.V.Tracey.

2. Phytochemistry Vol. I and II by Miller, Jan Nostrant Rein Hld.

3. Recent advances in Phytochemistry Vol. I to IV – Scikel Runeckles.

4. Chemistry of natural products Vol I onwards IWPAC.

5. Natural Product Chemistry Nakanishi Gggolo.

6. Natural Product Chemistry ―A laboratory guide‖ – Rapheal Khan.

7. The Alkaloid Chemistry and Physiology by THF Manske.

8. Introduction to molecular Phytochemistry – CHJ Wells, Chapmannstall.

9. Organic Chemistry of Natural Products Vol I and II by Gurdeep and Chatwall.

10. Organic Chemistry of Natural Products Vol I and II by O.P. Agarwal.

11. Organic Chemistry Vol I and II by I.L. Finar

12. Elements of Biotechnology by P.K. Gupta.

13. Pharmaceutical Biotechnology by S.P.Vyas and V.K.Dixit.

14. Biotechnology by Purohit and Mathoor.

15. Phytochemical methods of Harborne.

16. Burger‘s Medicinal Chemistry.

06 Hrs

Chemistry of Natural Products (Practical) 75 Hrs

1. Estimation of elements and functional groups in organic natural compounds.

2. Isolation, characterization like melting point, mixed melting point, molecular weight

determination, functional group analysis, co-chromatographic technique for

identification of isolated compounds and interpretation of UV and IR data.

3. Some typical degradation reactions to be carried on selected plant constituents.

63

M. Pharm- Pharmaceutics (MPC)

Paper Subject Code


II Advanced Pharmaceutics MPH02

III Biopharmaceutics and Pharmacokinetics MPH03

IV Novel Drug Delivery Systems MPH04

64

PAPER - I


Scope




Objectives





THEORY 75 HOURS





06 Hrs


Quenchers, Instrumentation and Applications of fluorescence spectrophotometer.

04 Hrs


Instrumentation, Interferences and Applications.

04 Hrs




spectroscopy

08 Hrs










14 Hrs




rules, Fragmentation of important functional groups like alcohols, amines, carbonyl

groups and alkanes, Meta stable ions, Mc Lafferty rearrangement, Ring rule,

Isotopic peaks, Tandem Mass Instruments, Interpretation and Applications of Mass

spectroscopy.

10 Hrs









10 Hrs

65





06 Hrs




03 Hrs


Dichroism, Measurement of rotaion angle in ORD and applications

03 Hrs


methods, Limitation and Applications of Radio immuno assay.

03 Hrs






REFERENCES: 1. Spectrometric Identification of Organic compounds - Robert M Silverstein,












edition,




8. Quantitative analysis of Pharmaceutical formulations by HPTLC - P D Sethi,

CBS Publishers, New Delhi.


Edition, Wiley

– Interscience Publications, 1961.



11. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume

11, Marcel Dekker Series


Elsevier, 2005



Journals:


2. Indian Drugs





04 Hrs

66
















67

Paper – II

Advanced Pharmaceutics

Scope

Course designed to impart basic knowledge and skills required to learn various parameters at

pharmaceutical industries

Objectives

To understand the elements of preformulation studies.

To understand the Active Pharmaceutical Ingredients and Generic drug Product

development

To learn Industrial Management and GMP Considerations.

To understand Optimization Techniques & Pilot Plant Scale Up Techniques

To study Stability Testing, sterilization process & packaging of dosage forms.

THEORY 75 HOURS

1. Preformulation

Physical characteristics: particle size, shape, surface area, Solubilization,

surfactants and its importance, temperature, pH, co-solvency; Techniques for the

study of crystal properties and polymorphism.

Chemical characteristics: Degradation, Hydrolytic, oxidative, reductive,

photolytic degradations;

Biopharmaceutics characteristics: solubility, dissociation,

Dissolution rate, diffusibility, and drug stability in GI tract. Physicochemical

characteristics of new drug molecules with respect to different dosage forms.

07 Hrs

2. Active Pharmaceutical Ingredients and Generic drug Product development

Process development, Bulk drugs process design, Design and construction of

facilities, Plant operation.

Solid oral dosage form- Introduction, Active pharmaceutical ingredients,

Experimental formulation development, Drug product performance,

Pharmaceutical alternative consideration for generic substitution

07 Hrs

3. Manufacturing operations and Control, GMP Considerations& Documentation

and records

Sanitation of Manufacturing premises, Mix-ups and Cross contaminations

processing of intermediates and Bulk Products, Packaging operations, IPQC in

manufacturing and Packaging, Release of finished products, process deviation,

Charge-in of components, Time limitations on production, Drug product

inspection, Expiration dating, Calculation of yield, Production record review,

Documents title, SOP, Online clearance and its records, SOP on internal labeling,

SOP of time limitation on production, Formats for area clearance/ machine

clearance, Temperature and relative humidity record, Tablet compression tooling,

Dye punch use log, Dye punch cleaning record, Batch movement record for

various dosage forms, Over printing line clearance sheet, Packaging operation and

inspection record, Packaging line clearance record.

Current Good manufacturing practices: Manufacturing facilities for tablets,

capsule, liquid orals, semisolids and parenterals as per schedule M. Certification

for pharmaceutical industries, US federal standard 209 E: Class designation,

testing and monitoring reports, calibrations, URS,FAT,DQ, SAT, IQ, OQ, PQ of

machines and equipment, WHO GMP minimum document check list, Schedule U

and U1. Master formula record as per WHO GMP and US FDA. Drug Master files

US FDA, Preparation for WHO GMP audit, preparation of Site Master File,

environment management system clauses. Technology transfer guidance.

10 Hrs

68

4. ISO 9000, ISO 14000, ISO 22000 series, CTD and eCTD, Accreditation

&Regulatory aspects

ISO 9000, ISO 14000, ISO 22000series – Salient features

CTD & eCTD –Salient features & Concepts

NABL accreditation and accreditation procedure, Patent regime and intellectual

property rights

Regulatory aspects related to Pharma Industries in India, UD FDA and European

commission, ANDA and NDA

06 Hrs

06 s

07 H

r

s

5. Optimization Techniques in Pharmaceutical Formulation, Industrial

Management

Concept of optimization, Optimization parameters, Factorial design, Optimization

technology & Screening design.

Principles of management, Financial management, Material management, Plant

Maintenance management, Inventory management, Production planning and

Control

06 Hrs

6. Pilot Plant Scale Up Techniques, Validation& Stability studies Significance of pilot plant scale up study, Large scale manufacturing techniques

(formula, equipment, process, stability and quality control) of solids, liquids,

semisolid and parenteral dosage forms, Guidelines USFDA-SUPAC (Scale up post

approve changes).

Validation –Concepts of TQM, Process, Analytical method and cleaning method

validation, validation master plan. ICH and WHO guidelines for validation and

calibration of equipments, Validation of computer systems, Validation of specific

dosage forms, Calibration of master plan, Documents & formats.

Accelerated stability testing & shelf life calculation, WHO and ICH stability testing

guideline, Stability zones, Photostability testing guidelines, ICH stability guidelines

for biological and biotechnological products, Stress testing programmes: Drug

substance characterization studies, Drug substances solid state characterization and

stability

10 Hrs

7. Sterilization Process& Aseptic technology

Principle, Advantages, Disadvantages, Applications of different sterilization

methods, Equipments, Steam quality testing, Sterile area monitoring system, In-

process control, Broth fill trails, Sterile validation, Sterile area maintenance –sterile

Filling, Rubber Bung placement, Flip off seal placement, Labelling, Validation of

autoclaves, DHS, Tunnel, Vial/Ampoule washing, Bungs (Rubber Stopper)

processing. Daily operation management of sterile equipment of autoclave- leak

test, steam penetration study for clothing and porous load. Chemical Indicators and

Biological Indicators and determination of Cold spots in the autoclave. Load

selection criteria for autoclaves. Steam quality testing methods and Limits.

Aseptic Filtration technique – Filter selection and compatibility, Qualification of

Filter, Bubble point testing, Documentation – Batch Manufacturing Record, Batch

Packing Record, Sterilization data sheet (retention of Washing equipment data and

autoclave, Dry Heat Sterilizer or Tunnel thermographs).Sterility testing: Principle,

general procedure, control tests,

10 Hrs

8. Human Resource Management, Pharmaceutical Project Management Organizational context, Job design and Job analysis, Human resource planning,

recruitment, Selections, Placement, Job evaluations, Performance appraisal,

globalization & Human resource management, Total quality & human resource

management, Recent techniques in human resource management, Job enlargement

and enrichment

06 Hrs

69

Project management of chemical, analytical and formulation development, Project

planning from basic concept to system applications, Strategic project management

at the project level & portfolio level, Project management and out sourcing drug

development, Project management functions.

9. Packaging of Pharmaceuticals

Pharmaceutical dosage form and their packaging requirments, Pharmaceutical

packaging materials, Medical device packaging, Enteral Packaging, Aseptic

packaging systems, Container closure systems, Issues facing modern drug

packaging, Selection and evaluation of Pharmaceutical packaging materials.

06 Hrs

10. Compaction and Compression& Industrial Safety

Compaction of powders with particular reference to distribution and measurement

of forces within the powder mass undergoing compression including- physics of

tablet compression, Effect of particle size, moisture content, Lubrication etc on

strength of tablets, Formulation challenges: Multiple vitamin and mineral dosage

forms, Formulation of specialty tablets for slow oral dissolution, Formulation and

design of veterinary tablets.

Industrial hazards due to fire accidents, mechanical and electrical equipments,

Chemicals and pharmaceuticals, Monitoring and preventive systems (Safety

measures).

07 Hrs

REFERENCES

1. Theory and Practice of Industrial Pharmacy By Lachmann and Libermann

2. Pharmaceutical dosage forms: Tablets Vol. 1-3 by Leon Lachmann.

3. Pharmaceutical Dosage forms: Disperse systems, Vol, 1-2; By Leon Lachmann.

4. Pharmaceutical Dosage forms: Parenteral medications Vol. 1-2; By Leon Lachmann.

5. Modern Pharmaceutics; By Gillbert and S. Banker.

6. Remington‘s Pharmaceutical Sciences.

7. Advances in Pharmaceutical Sciences Vol. 1-5; By H.S. Bean & A.H. Beckett.

8. Physical Pharmacy; By Alfred martin

9. Bentley‘s Textbook of Pharmaceutics – Rawbins.

10. Good manufacturing practices for Pharmaceuticals: A plan for total quality control,

Second edition; By Sidney H. Willig.

11. Quality Assurance Guide; By Organization of Pharmaceutical producers of India.

12. Drug formulation manual; By D.P.S. Kohli and D.H.Shah. Eastern publishers, New

Delhi.

13. How to practice GMPs; By P.P.Sharma. Vandhana Publications, Agra.

14. Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash.

15. Pharmaceutical Preformulations; By J.J. Wells.

16. Applied production and operations management; By Evans, Anderson, Sweeney and

Williams.

70

Advanced Pharmaceutics (Practicals) 75Hrs

1. Preformulation study of tablets.

2. Preparation and comparative evaluation with marketed products for antacid efficiency of

neutralizing property of suspensions.

3. Formulation and evaluation of stability of reconstituted dry syrup of amoxycillin,

Ampicillin etc.

4. Accelerated stability studies on various formulations, with reference to:

Temperature dependence.

Effect of buffers.

5. Determination of the order of decomposition for drugs like Aspirin, Benzocaine,

Acetanilide or any other three drugs.

6. Effect of hardness of the tablets on disintegration time.

7. Studying the stability of suspensions using the data on sedimentation volume and degree

of flocculation.

8. Determination of the critical micellar concentration of various surfactants by drop Weight

method or any other suitable method.

9. Determination of the optimum concentration of the surfactant for solubilisation (eg.

Peppermint oil with tween 20).

10. Study on the effect of various excipients on the dissolution rate of tablets.

11. Determination of particle size and size distribution of selected drugs by microscopy,

Sieving, sedimentation (using Andreasen pipette) etc.

12. Determinations of flow properties of powders by Angle of repose and flow through an

orifice with, and without glidants.

13. Sterility testing of commercially available injections like water for injection, Dextrose

Injection, Analgin injection.

14. Determination of stability of emulsions by studying the globule size.

15. Estimation of optimum concentration of the various glidants for the flow of granules

using angle of repose.

16. Other formulations based on the theory topics.

71

PAPER -III

Biopharmaceutics and Pharmacokinetics

Scope

This course is designed to impart knowledge and skills necessary for dose calculations, dose

adjustments and to apply biopharmaceutics theories in practical problem solving. Basic

theoretical discussions of the principles of biopharmaceutics and pharmacokinetics are

provided to help the students‘ to clarify the concepts.

Objectives At completion of this course it is expected that students will be able to –

define the basic concepts in biopharmaceutics and pharmacokinetics.

use raw data and derive the pharmacokinetic models and parameters the best describe

the process of drug absorption, distribution, metabolism and elimination.

critically evaluate biopharmaceutic studies involving drug product equivalency

design and evaluate dosage regimens of the drugs using pharmacokinetic and

biopharmaceutic parameters.

detect potential clinical pharmacokinetic problems and apply basic pharmacokinetic

principles to solve them

THEORY 75 HOURS

1. Absorption of Drugs

Structure of Cell membrane, Gastro-intestinal absorption of drugs, mechanisms

of drug absorption, Factors affecting drug absorption: Biological, Physiological,

Physico-chemical, pharmaceutical. Absorption of drugs from non-per oral

routes, Methods of determining absorption: In-vitro, in-situ and In-vivo

methods.

10 Hrs

2. Bioavailability

Objectives and considerations in bioavailability studies, Concept of equivalents,

measurement of bioavailability, Determination of the rate of absorption,

Bioequivalence and its importance, bioequivalence studies.

08 Hrs

3. Dissolution

Noyes - Whitney's dissolution rate law, Study of various approaches to improve

dissolution poorly soluble drugs, In-vitro dissolution testing models, In-vitro -

In-vivo correlation.

08 Hrs

4. Drug Distribution

Factors affecting drug distribution, Volume of distribution, Protein binding –

factors affecting, significance and kinetics of protein binding.

04 Hrs

5. Biotransformation

Phase I (Oxidative, reductive and hydrolytic reactions) and Phase II reactions

(conjugation), Factors affecting biotransformation.

05 Hrs

6. Pharmacokinetics

Basic considerations, Pharmacokinetic models, Compartment modeling: One

compartment model- IV bolus, IV infusion, Extra-vascular; Multi Compartment

models; Two compartment - model - IV bolus, IV infusion, Extra-vascular,

Three Compartment model in brief, Application of pharmacokinetics in new

drug development and designing of dosage forms and Novel drug delivery

systems.

20 Hrs

7. Non-Linear Pharmacokinetics

Cause of non-linearity, Michaelis-Menten equation, Estimation Kmax and Vmax.

05 Hrs

72

8. Excretion of Drugs

Renal and non-renal excretion, Concept of clearance - Renal clearance, Organ

clearance & Hepatic clearance.

05 Hrs

9. Dosage Regimen

Multiple dosing with respect to IV and oral route, Concept of loading dose,

maintenance dose, Accumulation index, Adjustment of dosage in renal and

hepatic impairment, Individualization of therapy, Therapeutic Drug Monitoring.

10 Hrs

REFERENCES:

1. Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi, 4th edition,

Philadelphia, Lea and Febiger, 1991

2. Biopharmaceutics and Pharmacokinetics, A. Treatise, D .M. Brahmankar and Sunil B.

J aiswal., Vallab Prakashan, Pitampura, Delhi

3. Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land YuABC, 2nd

edition, Connecticut Appleton Century Crofts, 1985

4. Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R. Hiremath,

Prism Book

5. Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel Dekker Inc.,

New York, 1982

6. Current Concepts in Pharmaceutical Sciences: Biopharmaceutics, Swarbrick. J, Lea

and Febiger, Philadelphia, 1970

7. Clinical Pharmacokinetics, Concepts and Applications 3rd edition by Malcolm

Rowland and Thom~ N. Tozer, Lea and Febiger, Philadelphia, 1995

8. Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack Publishing

Company, Pennsylvania 1989

9. Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 4th edition,

revised and expande by Robert. E. Notari, Marcel Dekker Inc, New York and Basel,

1987.

10. Biopharmaceutics and Relevant Pharmacokinetics by John. G Wagner and M.

Pemarowski, 1st edition, Drug Intelligence Publications, Hamilton, Illinois, 1971.

11. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G.

Boylan, Marcel Dekker Inc, New York, 1996.

Biopharmaceutics and Pharmacokinetics (Practicals) 75 Hrs

Suggested Practical Exercises: (At least 15 experiments to be conducted)

1. Improvement of dissolution characteristics of slightly soluble drugs by Various Solid

dispersion techniques and solvent deposition systems. (4 experiments)

2. Comparison of dissolution of two different marketed products /brands. (2

experiments)

3. Influence of polymorphism on solubility and dissolution. (2 experiments)

4. Protein binding studies of a highly protein bound drug & poorly protein bound drug.

(2 experiments)

5. Bioavailability studies of Paracetamol by salivary data.(1 experiment)

6. Calculation of Ka, Ke, t 1/2, Cmax and Tmax for two sets of data. (2 experiments)

7. Calculation of bioavailability from the given urinary excretion data for two drugs.

(2 experiments)

8. Calculation of AVC and bioequivalence from the given data for two drugs.

(2 experiments)

73

PAPER - IV

Novel Drug Delivery Systems

Scope

This course is designed to impart knowledge on the area of advances in novel drug delivery

systems.

Objectives

Upon completion of the course student shall be able

to understand various approaches for development of novel drug delivery systems.

to understand the criteria for selection of drugs and polymers for the development of

Novel drug delivery systems, their formulation and evaluation.

THEORY 75 HOURS

1. Sustained Release Formulations: Introduction, terminology/definitions and rationale, advantages and disadvantages.

Types of control release products, factors influencing the design and performance of

SR formulations. Physicochemical and biological properties of drugs relevant to

sustained release formulations.

06 Hrs

2. Polymer Science: Introduction, classification, properties, advantages and application

of polymers in formulation of controlled drug delivery systems. 06 Hrs

3. Concept and System Design for the Rate-Controlled Drug Delivery: Introduction,

classification, fundamental concepts and technical principles of rate-pre-programmed

DDS, activation- modulated DDS, feedback-regulatedDDS. Effects of system

parameters on controlled release drug delivery.

06 Hrs

4. Oral Drug Delivery and Delivery Systems: Introduction, development of novel

DDS for oral controlled release drug administration, modulation of GI transit time.

Approaches to extend GI transit time of DDS.

08 Hrs

5. Mucosal Drug Delivery: Introduction, Principles of mucoadhesion, concepts,

advantages and disadvantages, transmucosal permeability, formulation and

evaluation of buccal, nasal and pulmonary drug delivery systems.

08 Hrs

6. Ocular Drug Delivery Systems: Introduction, controlled ocular drug delivery-

requisites & approaches for ocular drug delivery devices-matrix type, capsular type &

implantable types.

06 Hrs

7. Transdermal Drug Delivery Systems: Introduction, Permeation through skin,

factors affecting permeation, permeation enhancers, basic components of TDDS

formulation and evaluation of transdermal drug delivery systems.

07 Hrs

8. Parenteral Drug Delivery Systems: Definition, advantages and disadvantages,

Approaches for injectable controlled release formulations with examples, formulation

and evaluation of Implantable drug delivery systems.

06 Hrs

9. Intrauterine Drug Delivery Systems: Introduction, Development of intra uterine

devices (IUDs), advantages and disadvantages, types, copper IUDs, hormone-

releasing IUDs.

06 Hrs

10. Targeted Drug Delivery Systems: Concept. Advantages and disadvantages,

biological processes and event involved in drug targeting, drug targeting through

various systems like nanoparticles, liposomes, resealed erythrocytes, microspheres,

magnetic microspheres, ethosomes, aquasomes, niosomes, phytosomes and

monoclonal antibodies.

08 Hrs

74

11. Protein and Peptide Drug Delivery: Manifestation of protein instability and

stability. Drug delivery systems for proteins and peptides with special reference to

oral & nasal routes.

04 Hrs

12. Hydrogels: Structure and properties, classification- diffusion controlled, swelling

controlled, chemically controlled and environmentally controlled. Applications. 04Hrs

REFERENCES

1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded,

Marcel Dekker, Inc., New York, 1992.

2. Robinson, J. R., Lee V. H. L, Controlled Drug Delivery Systems, Marcel Dekker,

Inc., New York, 1992.

3. Encyclopedia of controlled delivery, Editor- Edith Mathiowitz, Published by Wiley

Interscience Publication, John Wiley and Sons, Inc, New York! Chichester/Weinheim

4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New

Delhi, First edition 1997 (reprint in 2001).

5. S.P.Vyas and R.K.Khar, Controlled Drug Delivery - concepts and advances, Vallabh

Prakashan, New Delhi, First edition 2002.

Journals

1. Indian Journal of Pharmaceutical Sciences (IPA)

2. Indian drugs (IDMA)

3. Journal of controlled release (Elsevier Sciences) desirable

4. Drug Development and Industrial Pharmacy (Marcel & Decker) desirable

Novel Drug Delivery Systems (Practicals)

Suggested practical experiments (at least 15 experiments to conducted)

1. Preparation and evaluation of albumin microspheres

2. Preparation and evaluation of microcapsules by different microencapsulation

technique

3. Preparation and evaluation of matrix tablets using various polymers

4. Study on diffusion of drugs through various polymeric membranes

5. Preparation and in vitro evaluation of buccal mucoadhesives

6. Preparation and evaluation of transdermal films

7. Preparation and evaluation of hydrodynamically balanced tablets

8. Study of in vitro dissolution of various sustained release formulations of marketed

products

75

M. Pharm- Pharmacognosy (MPG)

Paper Subjects Code


II Advanced Pharmacognosy and

Phytochemistry MPG02

III Medicinal Plant Biotechnology MPG03

IV Natural Products of Medicinal Interest MPG04

76

PAPER - I


Scope



IR, HPLC, GC etc.

Objectives: After completion of course student is able to know,




THEORY 75 HOURS



Spectrophotometric titrations, Wood ward – Fiesure rule, Applications of UV-Visible

spectroscopy.

06 Hrs


Quenchers, Instrumentation and Applications of fluorescence spectrophotometer.

04 Hrs


Instrumentation, Interferences and Applications.

04 Hrs




spectroscopy

08 Hrs










14 Hrs


Different types of ionization like electron impact, chemical, field, FAB and MALDI,

Analyzers of Quadrupole and Time of Flight, Mass fragmentation and its rules,

Fragmentation of important functional groups like alcohols, amines, carbonyl groups

and alkanes, Meta stable ions, Mc Lafferty rearrangement, Ring rule, Isotopic peaks,

Tandem Mass Instruments, Interpretation and Applications of Mass spectroscopy.

10 Hrs



a) Paper chromatography b) Thin Layer chromatography c) Ion exchange

chromatography d) Column chromatography e) Gas chromatography f) GC-MS




10 Hrs



a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis

d) Zone electrophoresis e) Moving boundary electrophoresis f) Iso electric focusing

06 Hrs

77




03 Hrs



03 Hrs

11. Radioimmunoassay: Importance, various components, Principle, Different methods,

Limitation and Applications of Radio immuno assay.

03 Hrs


distribution, probability, degree of freedom, standard deviation, correlation, variance,

accuracy, precision, classification of errors, reliability of results, confidence interval,

test for statistical significance – Students T test, F test, Chi square test, Correlation

and regression.

04 Hrs

REFERENCES: 1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition,

John Wiley & Sons, 2004.


3. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A.

Nieman, 5th


4. Vogel‘s Text book of quantitative chemical analysis - Jeffery, Basset, Mendham,

Denney, 5th





edition, CBS

Publishers, New Delhi, 1997.



8. Quantitative analysis of Pharmaceutical formulations by HPTLC - P D Sethi, CBS

Publishers, New Delhi.


Edition, Wiley –

Interscience Publications, 1961.


Edition,


11. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume 11, Marcel

Dekker Series

12. Analytical Profiles of Drug substances – Klaus Florey, Volume 1 – 20, Elsevier, 2005

13. Analytical Profiles of Drug substances and Excipients – Harry G Brittain, Volume 21 –

30, Elsevier, 2005.

Journals:


2. Indian Drugs





78

Modern Analytical Techniques (Practicals)















79

PAPER –II

Advanced Pharmacognosy & Phytochemistry

Scope To learn and understand the advances in the field of cultivation and production of plant drugs,

neutraceuticals and their evaluation techniques

Objectives: Upon completion of the course, the student shall be able to

know the advances in the cultivation and production of crude drugs

know the evaluation techniques for the herbal drugs.

THEORY 75 Hour

1. Exogenous and endogenous factors influencing production of drugs, Plant

Growth Regulators and their application in Pharmacy. Disease management

of medicinal and aromatic plants.

06 Hrs

2. Profiles for Commercial Cultivation Technology and Post Harvest Care of

following medicinal plants – Ashwagandha, Periwinkle, Medicinal Yam,

Guggual, Neem, Psyllium, Ammimajus, Gymnema, Stevia, Aloe, Saffron,

Forskoli, Artemisia, Guduchi, Kalmegh, Punarnava and Ginseng

12 Hrs

3. Technology for commercial scale cultivation, processing and modern

methods of extraction including SCF, Microwave assisted extraction of

following aromatic plants- Lemon grass, Gerenium, Basil, Palmarosa,

Vetiver, Patchouli, Japaneese Mint, Rose, Hops, Jasmine, Sandal, Dill,

Celery, Anise, Davana and Eucalyptus

12 Hrs

4. Emerging plant drugs: A review and current status of anti-hepatotoxic, anti-

fertility, anti-malarial, anti-hypertesive, anti-biotic, anti-cancer, anti-diabetic

and immunomodulatory plant drugs.

12 Hrs

5. Problem encountered in and prospects of discovering new drugs from plants.

Natural substances as raw materials in drug synthesis. Biomedicinals of

recent discovery.

05 Hrs

6. Bio evaluation of herbal drugs.

Anti- inflammatory activity

Hypoglycemic activity

Antiviral and antibacterial activity

Antineoplastic activity

Antiulcer activity

Hepatoprotective activity

12 Hrs

7. Drugs and pharmaceuticals from marine source (Marine Pharmacognosy),

with special reference to Cardiovascular, Cytotoxic, Antimicrobial and Anti-

inflammatory compounds.

04 Hrs

8. Herbal Neutraceuticals, Herbal Cosmetics and Herbal Teas. Manufacture,

packaging and approach to quality control aspects including pesticide

residue, Heavy Metal content, Microbial contamination and GMP for Herbal

drug formulations,Standardization of herbal raw material/extracts as per

WHO /CCMP guidelines

08 Hrs

9. Pharmaceutical aids : Profile for manufacture of papain, pectin,

Pharmaceutical gums, starch, absorbent cotton and gelatin

04 Hrs

80

Advanced Pharmacognosy & Phytochemistry (Practicals) 75 Hrs

1. Thin layer Chromatography

2. Paper Chromatography

3. Column Chromatography

4. Pharmacognostic evaluation of crude drugs

5. Extractive value determination

6. Ash value determination

7. Moisture content determination

8. Volatile oil content determination

9. Estimation of volatile oil content by UV; spectral analysis

10. Spectroscopic analysis of isolated compounds.

11. Monograph analysis of Crude drugs

12. Monograph analysis of marine products

13. Monograph analysis of volatile oils

14. Evaluation and standardization of nutraceuticals.

15. Bioevaluation of herbal drugs for


Hypoglycemic activity, Diuretic

Cardiac activity



Antifertility activity

Screening of in vitro antioxidant activity

Antiulcer activity


16. Quantitative microscopy analysis.

ASSIGNMENTS

Students are required to submit written assignments on the topics given to them. Topics

allotted should cover recent developments in drug therapy of various diseases. A minimum of

THREE assignments [1500 – 2000 words] should be submitted for evaluation.

REFERENCES:

1. Cultivation of medicinal and aromatic crops, 1st edition, by AA Farooqui and B.S.

Sreeramu. University Press, 2001.

2. Medicinal Plants of India, 1st edition, by S.N. Yoganarasimhan, Interlilne Publishing

Pvt. Ltd.. 2000.

3. Medicinal natural products (a biosynthetic approach), 1st edition, by Paul M. Dewick,

John Wiley & Sons Ltd., England, 1998.

4. Natural Products from Plants, 1st edition, by Peter B. Kaufman, CRC Press, New

York, 1998

5. Glimpses of Indian Ethano Pharmacology by P. Pushpangadam. Ulf Nyman.

V.George Tropical Botanic Garden & Research Institute, 1995.

6. Natural products: A lab guide by Raphael Ikan , 2nd Edition, Academic Press 1991.

7. Organic Chemistry of Natural Products, Vol. 1&2. Gurdeep R Chatwal.

8. Organic Chemisrty; I.L. Finar - Vol. I&II.

9. Pharmacognosy - G. E. Trease and W.C. Evans. 15th Edition W.B. Saunders

Edinburgh,New York.

81

10. Pharmacognosy-Tyler, Brady, Robbers

11. Modem Methods of Plant Analysis- Peach & M.V. Tracey, Vol. I&II

12. Phytochemistry -Vol. I to IV. Miller Jan Nostrant Renhold.

13. Recent Advances in Phytochemistry- Vol. 1&4: Scikel Runeckles- Appleton Century

crofts.

14. Chemistry of Natural Products- Vol. 1 onwards IWPAC.

15. Natural Products Chemistry Nakanishi Golo.

16. The Essential Oils- Ernest Guenther- Robbert E. Kreiaer

17. The Alkaloids chemistry & Physiology- Vols. RH F Manske

18. Introduction to Molecular Phytochemistry- Paul J. Schewer 1973.

19. Chemistry of Marine Natural Products- Paul J. Schewer 1973.

20. Marine Pharmacognosy Ed. by Dean F. Martin & George Padilla.

21. Marine Natural Products-Vol.I to IV.

22. Comparative Phvtochemistry edited by T. Swain.

23. Chemical Plant Taxonomy edited by T. Swain.

24. Cultivation of Medicinal Plants by C.K. Atal & B.M. Kapoor.

25. Cultivation and Utilization of Aromatic Plants By C.K. Atal & B.M. Kapoor

26. Plant Propagation Principles and Practices- Hartmann Kester.

27. Ayurvedic Formulary of India , Government of India.

28. Herbal Drug Iudustry by RD. Choudhary, 1st edition, Eastern Publisher, New Delhi,

1996.

29. Pharmacognosy and Phytochemistry of medicinal plants by Jean Bruneton, Technique

and documentation- Lavoiser, 1995.

30. Text book of Pharmacognosy by C.K.Kokate, Purohit, Ghokhale, 4th edition, Nirali

Prakasshan, 1996.

31. Pharmacognosy and Pharmacobiotechnology by Ashutoshkar, New Age Publications,

New Delhi.

32. Text Book of Pharmacognosy by T.E. Wallis

33. Pharmacopoeial Standards for Ayurvedic Formulations, Central Council for Research

in Ayurvedha and Siddha, New Delhi.

82

PAPER –III

Medicinal Plant Biotechnology

Scope To explore the knowledge of Biotechnology and its application in the improvement of quality

of medicinal plants

Objectives Upon completion of the course, the student shall be able to

know the process like genetic engineering in medicinal plants for higher yield of

Phytopharmaceuticals.

use the biotechnological techniques for obtaining and improving the quality of natural

products/medicinal plants

THEORY 75 HOURS

1. Historical perspectives, prospects for development of plant biotechnology as source

of medicinal agents. Applications in pharmacy and allied fields. 06 Hrs

2. A. Types, Techniques, nutritional requirements and growth of plant tissue

cultures.

Organogenesis and embryogenesis. Protoplast fusion, Hairy root multiple

shoot cultures and their applications. Micro propagation of medicinal and

aromatic plants.

10 Hrs

B. Immobilization techniques of plant cell and its application on secondary

metabolite production.

Cloning of plant cell: Different methods of cloning and its applications,

advantages and disadvantages of plant cell cloning

10 Hrs

3. (I). Secondary metabolism in tissue cultures with emphasis on production of

medicinal agents.

(II). Precursors and elicitors on production of secondary metabolites.

05 Hrs

4. Biotransformation, bioreactors for pilot and large scale cultures of plant cells and

retention of biosynthetic potential in cell culture. 07 Hrs

5. I. Transgenic plants, methods used in gene identification, localization and

sequencing of genes.

II. Application of PCR in plant genome analysis.

III. Screening and selection of high yielding cell lines.

IV. ELISA methods used to certify pathogens in Plants.

16 Hrs

6. Techniques employed in elucidation of biosynthetic pathways. 08 Hrs

7. Application of Fermentation technology

a. Pencillin, Vit B12, Vit C, Dextrose from starch and cellulose.

b. Vit B1, Vit E, Vit B2 and Streptomycin.

c. Production of single cell proteins

d. Industrial fermentation and pharmaceutical effluents-Its treatment and legal

requirements.

10 Hrs

8. Conservation of medicinal plants: In Situ and Ex Situ conservation 3 Hrs

83

REFERENCES:

1. Plant tissue culture – Bhagwani, Vol 5. ( Elsevier)

2. Plant cell and Tissue Culture ( Lab. Manual ) – J.R.M.M. Yeoman.

3. Medicinal Natural products IInd Edn. ( A Biosynthetic Approach) Paul M. Dewick.

4. Elements in biotechnology by P. K. Gupta.

5. Molecular biology and biotechnology by J. M Walker and E. D. Gingold.

6. An introduction to plant tissue culture by M. K. Razdan.

7. Breeding field crops by John. M. P and David A. S.

8. Advanced methods in plant breeding and biotechnology by David. R. Murray.

9. Experiments in plant tissue culture by John H. D and Lorin W. R.

10. Pharmaceutical biotechnology by S. P. Vyas and V. K. Dixit.

11. Plant cell and tissue c culture by Jeffrey W. Pollard and John M Walker.

12. Plant tissue culture by Dixon, Oxford Washington DC, 1985

13. Plant tissue c culture by Street.

14. Pharmacognosy by G. E. Trease and W. C. Evans.

15. Biotechnology by Purohit and Mathur.

16. Biotechnological applications to tissue culture by Shargool.

17. Pharmacognosy by Virroo E. Tyler, Lynn R. Brady and James E. Robberrt.

18. Introduction to biotechnology by Bullock John.

19. Biotechnology of higher plants by Gordon E. Russel.

20. Antibiotics isolation and separation by M. L. \Venisten and G. H Wagman.

21. Plant cell culture technology by M. M. Yeoman.

22. Plant tissue Culture by Dennis N. Butcher and David .S. Ingram.

23. Plant tissue Culture by Pitman.

24. Plant tissue Culture - Theory and practice by S. S. Bhajwani and M. K. Razdan.

25. Secondary plant metabolism by Margaret L. Vikery and Brian Vikery.

26. Plant tissue culture by W. E. George.

Medicinal Plant Biotechnology Practicals

1. Media Preparation and sterilization

2. Inoculation of explants in to media

3. Initiation of callus

4. Growth determination – Cell counts, Cell staining, Media analysis.

5. Organogenesis

6. Chromosomal analysis by onion root tip culture.

7. Suspension culture and secondary metabolite production.

8. Isolation of DNA from plant sources.

9. Isolation of RNA from plant sources.

10. Estimation of DNA.

11. Estimation of RNA.

12. Isolation of enzymes.

13. Immobilization of enzymes and study of their activity

14. Isolation and fusion of protoplast.

15. Gene transfer in plant cells using agarobacterium.

16. Isolation of plasmids.

17. Restriction enzyme digestion.

18. Transformation of bacteria.

19. Isolation and estimation reducing sugar from plant source.

20. Isolation of chloroplast.

84

Paper – IV

Natural Products of Medicinal Interest

Scope To explore the knowledge of natural product chemistry including the extraction techniques,

identification tests and separation techniques of various phytoconstituents

Objectives Upon completion of the course, the student shall be able to

know the techniques of extraction, identification, separation and structural elucidation

of compounds.

apply the knowledge of natural products chemistry in the synthetic derivatives of the

same

THEORY 75 HOURS

1. Phytochemical screening of crude drugs, extraction and qualitative evaluation for

drug constituents, preparations of biomedicinals for characterization. Application of

various chromatographic techniques for the isolation of phytoconstituents and

evaluation of biomedicinals

08 Hrs

2. Methodology for extraction, chemistry and estimation of Artimesinin,

Ginsengosides, Solasodine, Berberine, withaferin, phyllanthin, Scopolamine,

Atropine, Emetine, Ergot alkaloids, Caffeine, Taxol, Withanoloids,

Podophyllotoxin, Cod –liver oil and Shark-liver oil

08 Hrs

3. Biogenesis of Tropane, Quinoline, Imidazole, Isoquinoline, and Indole alkaloids;

Sterols, Anthraquinone and saponin glycosides; Flavanoids; and Isoprenoid

compounds of Pharmaceutical significance

08 Hrs

4. Recent trend in utilization of vegetable laxatives and vegetable bitters. Natural

coloring and sweetening agents. Natural pigments: Isolation, identification,

Classification and chemistry of Carotenoid, Flavanoid pigments including

Anthocyanins, Flavonols and Flavones, Quinine pigments

07 Hrs

5. Terpenoids: Introduction, Essential oils, Diterpenoids, Triterpenoids and

sesquiterpenoids

05 Hrs

6. Chemistry and sources of important Saponin and sapagenins including Sarsaponin,

Solanidine, Diosgenin, Hecogenin, α-Amyrin, β-Amyrin, Lupeol, Glycyrrhizinic

acid, Asiaticoside and other steroidal saponins

07 Hrs

7. Nitrogenous compounds:

Alkaloids : Natural occurrence, Chemistry of Opium, Ergot, Vinca alkaloids,

Tropane alkaloids, Quinoline alkaloids, Steroidal alkaloids including Solanum and

Kurchi alkaloids

10 Hrs

8. Cyanogenic glycosides including amygdalin and Prunasin 04 Hrs

9. An introduction to natural products as leads to design of new drugs. (e.g.

Antidiabetic, Anti-cancer – Taxol, Podophyllotoxin, Gengokolides, Ginsenosides,

Artemisinin.)

08 Hrs

10. Herbal Formulation (General considerations): Single and composite drug

formulation, its various types; (Churna, Leha or Avaleha, Gutika or Uati, Bhasmas,

Asacoad arisha etc.); formulations using herbal extracts / pure

Phytopharmaceuticals. Standardization of herbal Formulations.

08 Hrs

REFERENCES 1. Chemistry of Alkaliods by S.W. Pelletier

2. Alkaloids by Manske

3. Plant Physiology by Dieter Hess

85

4. Steroids by Fieser and Fieser

5. Organic chemistry by i.L. Finar Vol.II

6. Chemistry of Natural Products by k.W. Bentley

7. Biosynthesis of Aromatic Compounds by Ulrich Weiss & J. Michael Edwards.

8. Journals

a) Phytochemistry, b) Planta medica c) Phytotherapy Research, d) Fitoterapia

9. Pharmacognosy by Trease and Evans, ELBS.

10. Pharmacognosy by Tylor and Brody.

11. Text book of Pharmacognosy by Wallis.

12. Clark‘s isolation and Identification of drugs by A.C. Mottal.

13. Introduction to chromatography theory and practical by Srivastava, K. Kishore.

14. Plant Drug Analysis by Wagner.

15. Indian Pharmacopoeia.

16. United States Pharmacopoeia.

17. Practical Evaluation of Phytopharmaceuticals by K.r. Brain, T.D. Turner.

18. Research guideline for evaluating the safety and efficacy of herbal medicines WHO

publications.

19. CMPC Guidelines.

20. Techniques in Organic Chemistry by Weiss Creger.

21. Wilson and Gisvolds text book of Organic Medicinnal and Pharmaceutical

Chemistry by Deorge. R.F.

22. Hand Book of vitamins by Maachtein.

23. Recent Progress in Medicinal Plants Vol1-22, D.K. Majumdar, J.N. Govil,

V.K.Singh, Rajeev. Kr. Sharma, Studium Press, LLC. U.S.A.,

24. The Chemistry of Natural Products, Edited by R.H. Thomson, Springer

International Edn. 1994.

25. Natural Products Chemistry Practical Manual by Anees A Siddiqui and Seemi

Siddiqui

Natural Products of Medicinal Interest Practicals 100 Hrs 1. General extraction of phytopharmaceuticals.

2. Phytochemical tests for various phytopharmaceuticals.

3. Introduction of chromatography techniques for the isolation of constituents.

4. Isolation and estimation of berberine

5. Isolation and estimation of atropine

6. Isolation and estimation of hesperidine

7. Isolation and estimation of caffeine

8. Isolation and estimation of Withanolide

9. Isolation and estimation of gingerol

10. Isolation and estimation of gymnemic acid.

11. Isolation and estimation of Piperine

12. Isolation and estimation of forskolin.

13. Isolation of essential oils and estimation of them by spectral, chemical analysis.

14. Estimation of quinine by fluorimetry.

15. Arista formulation development and its standardization.

16. Asava formulation development and its standardization.

ASSIGNMENTS

Students are required to submit written assignments on the topics given to them.

Topics allotted should cover recent developments in drug therapy of various diseases. A

minimum of THREE assignments [1500 – 2000 words] should be submitted for evaluation.

87

M. Pharm - Pharmacology

Paper Subject Code


II Advanced Pharmacology MPL02

III Pharmacologica1 & Toxicological Screening Methods. MPL03

IV Drug Design and Molecular Pharmacology MPL04

88

PAPER - I


Scope



IR, HPLC, GC etc.

Objectives





THEORY 75 HOURS





06 Hrs








spectroscopy

08 Hrs










14 Hrs







10 Hrs



a) Paper chromatography b) Thin Layer chromatography c) Ion exchange

chromatography d) Column chromatography e) Gas chromatography f) GC-MS

g) High Performance Liquid chromatography h) LC-MS i) High Performance Thin

Layer chromatography k) Super critical fluid chromatography l) Affinity

chromatography

10 Hrs



a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis d) Zone

electrophoresis e) Moving boundary electrophoresis f) Iso electric focusing

06 Hrs

89




03 Hrs










04 Hrs

REFERENCES 1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition,




Nieman, 5th



Denney, 5th





edition, CBS







Edition, Wiley –



Edition,



Dekker Series



30, Elsevier, 2005.

Journals:


2. Indian Drugs





90
















91

Paper – II

Advanced Pharmacology (Theory)

Scope

The subject is designed to strengthen the basic knowledge in the field of pharmacology and to

impart recent advances in the drugs used for the treatment of various diseases. In addition, the

subject helps the student to understand the concepts and design clinical trial according to

various guidelines and also to understand the importance of Adverse Drug Reactions (ADR),

Therapeutic Drug Monitoring (TDM) and Pharmacovigilance.

Objectives

Upon completion of the course the student shall be able to:

explain the mechanism of drug actions at cellular and molecular level

discuss the pathophysiology and pharmacotherapy of certain diseases

understand the adverse effects, contraindications and clinical uses of drugs used in

treatment of diseases

appreciate the role of antioxidants in the free radical mediated diseases

design a clinical trial for new drugs as per the guidelines

THEORY 75 HOURS

1. General Pharmacology

a. Pharmacokinetics: The dynamics of drug absorption, distribution, biotransformation

and elimination

b. Pharmacodynamics: Mechanism of drug action and the relationship between drug

concentration and effect. Receptors, structural and functional families of receptors,

classification of receptors. Quantitation of drug receptors interaction and elicited

effects

16 Hrs

2. Neuro transmission

a. General aspects and steps involved in neurotransmission.

b. Neurohumoral transmission in autonomic nervous system (Detailed study about

neurotransmitters- Adrenaline and Acetyl choline).

c. Neurohumoral transmission in central nervous system (Detailed study about

neurotransmitters- histamine, serotonin, dopamine, GABA, Glutamate and Glycine].

d. Non adrenergic non cholinergic transmission (NANC). Co-transmission

05 Hrs

3. Systemic Pharmacology

A detailed study on pathophysiology of diseases, mechanism of action,

Pharmacology and Toxicology of existing as well as novel drugs used in the following

systems

a. Autonomic Pharmacology

Parasympathomimetics and lytics, sympathomimetics and lytics, agents affecting

neuromuscular junction.

b. Central nervous system Pharmacology

General and local anesthetics, sedatives and hypnotics, drugs used to treat anxiety,

depression, psychosis, mania, epilepsy, neurodegenerative diseases, Analgesics and

Non – steroidal anti- inflammatory agents (NSAIDs).

c. Cardiovascular Pharmacology

Diuretics, antihypertensives, antiischemics, anti- arrhythmics, drugs for heart failure

and hyperlipidemia. Effect of drugs on blood constituents.

35 Hrs

92

d. Autocoid Pharmacology

The physiological and pathological role of Histamine, Serotonin, Kinins

Prostaglandins, Opioid autocoids

Pharmacology of Antihistamines, 5HT antagonists and Anti-migraine drugs.

e. Immunopharmacology

Cellular and biochemical mediators of inflammation and immune response. Allergic or

hypersensitivity reactions. The characteristics, pathogenesis and Pharmacotherapy of

asthma and COPD.

Immunosuppressants and Immunomodulators

f. GIT Pharmacology

Anti ulcer drugs, Prokinetics, anti emetics, anti-diarrheals and drugs for constipation

and irritable bowel syndrome.

g. Endocrine Pharmacology

Molecular and cellular mechanism of action of hormones such as growth hormone,

prolactin, thyroid, insulin and sex hormones

Anti-thyroid drugs, Oral hypoglycemic agents, Oral contraceptives, Corticosteroids.

Drugs affecting calcium regulation

h. Chemotherapy

Cellular and molecular mechanism of actions and resistance of antimicrobial agents

such as β-lactams, antiviral, anti-TB, and anticancer drugs.

4. Free radicals Pharmacology

Generation of free radicals, role of free radicals in etiopathology of various diseases

such as diabetes, neurodegenerative diseases and cancer.

Protective activity of certain important antioxidant.

3 Hrs

5. Clinical Pharmacology a. Basics in clinical Pharmacology, Clinical trials of drugs design and testing of drugs

in humans (Phase I –Phase IV) according to GCP, ICH and ICMR guidelines.

Adverse drug reactions and concepts of drug interactions.

b. Fundamentals of clinical trials: Protocols, volunteers, informed consent, ethical

committee designs (Single blind, double blind, cross over, randomization, placebos,

and controlled studies).

c. Therapeutic drug monitoring- Criteria for TDM, specific examples viz; digoxin,

aminoglycosides and theophylline.

d. General aspects of Pharmacovigilance.

10 Hrs

6. Biological assays

Principles and methods of biological assay. Bioassay of drugs in Indian Pharmacopeia

(Insulin, Oxytocin, Vasopressin)

06 Hrs

REFEERENCES

1. The Pharmacological basis of therapeutics- Goodman and Gill man‘s

2. Pharmacotherapy- Dipiro

3. Basic and Clinical Pharmacology by B.G -Katzung

4. Pharmacology by H.P. Rang and M.M. Dale.

5. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.

6. Principles of drug action by Goldstein, Amaow and Kalman

7. Clinical Pharmacology by Molmon and Morelli

8. Clinical trials and tribulations by Allien E.Cato

9. Text book of Therapeutics, drug and disease management by E T. Herfindal and Gourley.

10. Pharmacological Experiments on intact preparations by Churchill Living stone.

11. Fundamentals of experimental Pharmacology-by M.N.Ghosh

12. Hand book of Experimental Pharmacology-S.K.Kulakarni

93

13. Text book of in vitro practical Pharmacology by Ian Kitchen

14. Bioassay Techniques for Drug Development by Atta-ur-Rahman, Iqbal choudhary and

William Thomsen

JOURNALS

1. Indian Journal of Pharmacology.

2. Indian Journal of Physiology and Pharmacology.

3. Indian Journal of Experimental Biology.

4. Pharmacological research.

Advanced Pharmacology (Practicals) 75 Hrs

1. Experiments for studying the effects of the more important biogenic agents like

histamine, acetyl choline, 5HT, oxytocin and their effect in the presence of antagonist on

suitable isolated tissue preparations.

2. Estimation of concentration of agonists using suitable isolated preparations by

interpolation/matching bioassay.

3. Estimation of concentration Ach using rat colon/ileum by three/four point bioassay

4. Estimation of concentration of histamine on guinea pig ileum by three/four point

bioassay

5. Estimation of PA2 values of various antagonists under suitable isolated tissue

preparations.

6. Experiments on CVS: Effect of various drugs on isolated heart preparations on various

animal models under normal arrhythmic and hypodynamic conditions.

7. Estimation of biochemical and free radical scavengers in blood and tissue homogenates.

8. Drug absorption and elimination studies.

9. Protocol designing of clinical trials.

94

Paper – III

Pharmacological and Toxicological Screening Methods (Theory)

Scope

This subject is designed to impart the knowledge regarding the preclinical drug evaluation

techniques in the drug discovery and development. The subject content helps the student to

understand the maintenance of laboratory animals as per the guidelines, basic knowledge of

various in-vitro and in-vivo preclinical evaluation processes, the newer methods of toxicity

testing, and various guidelines for conducting toxicity studies. The fundamentals of

intellectual property right help the student to upgrade their knowledge as per the need of

Pharma industry. This course offer practical advantages in fine-tuning the understanding of

various drug evaluation techniques by using various experimental animals.

Objectives

Upon completion of the course the student shall be able to,

apprise the regulations and ethical requirement for the usage of experimental animals.

describe the various animals used in the drug discovery process and good laboratory

practices in maintenance of experimental animals.

describe the various newer screening methods involved in the drug discovery process.

learn the applicability and importance of biostatistics in preclinical research.

appreciate and correlate the preclinical data to humans.

THEORY 75 HOURS

1. Laboratory Animals

Commonly used laboratory transgenic and genetically prone animals models (Viz, nude

mice, SH rats etc). Techniques of blood collection, anaethesia and euthanasia of

experimental animals. Various routes of drug administration. Maintenance and breeding

of laboratory animals. Regulations and ethics requirements according to CPCSEA

guidelines. Good laboratory practice.

09 Hrs

2. Preclinical screening of new substances for the pharmacological activity using in

vivo, in vitro, and other possible animal alternative models.

a. General principles of preclinical screening.

b. Cardiovascular Pharmacology: antihypertensives, antiarrythmics, antianginal,

antiatherosclerotic agents and diuretics.

c. CNS Pharmacology: behavioral and muscle co ordination, CNS stimulants and

depressants, anxiolytics, anti-psychotics, anti epileptics and nootropics.

d. Drugs for neurodegenerative diseases like Parkinsonism, Alzheimers and multiple

sclerosis.

e. Drugs acting on Autonomic Nervous System.

f. Respiratory Pharmacology: antiasthmatics, drugs for COPD and anti allergics.

g. Reproductive Pharmacology: Aphrodisiacs and antifertility agents

h. Analgesics, anti inflammatory and antipyretic agents.

i. Gastrointestinal drugs: anti ulcer, anti -emetic, anti-diarrheal and laxatives.

j. Drugs for metabolic disorders like anti-diabetic, antihyperlipidemic, and

hepatoprotective agents.

k. Anti cancer agents.

l. Immunosuppressants and immunomodulators

36 Hrs

3. Essentials of Toxicology

Physico-chemical, biochemical and genetic basis of toxicity Principles of toxicokinetics,

mutagenesis and carcinogenesis. Guidelines and regulatory agencies to conduct the

studies (OECD and ICH). Behavioral, inhalation, cellular and sub cellular toxicity.

08 Hrs

95

Range finding tests, acute, subacute and chronic toxicity studies and reproductive

toxicology according to OECD and ICH guidelines.

4. Limitations of animal experimentation and alternate animal experiments.

Extrapolation of in vitro data to preclinical and preclinical to humans 05 Hrs

5. Immuno assay General principles of immunoassay: theoretical basis and optimization of

immunoassay, heterogeneous and homogenous immunoassay systems. Immunoassay

methods evaluation; protocol outline, objectives and preparation. Immunoassay for

digoxin and insulin

03 Hrs

6. Bio-statistics

An introduction to statistics and biostatistics collection and organization of data.

Probability, regression, parametric and non parametric tests.

05 Hrs

7. Fundamentals of Intellectual Property (IP) a. Intellectual Property (IP)

Concepts regarding intellectual property (IP), Intellectual Property Protection IPP)

and Intellectual Property Rights (IPR); economic importance, mechanism for

protection of intellectual property patents, copyrights, trade mark; factors affecting

choice of IP protection; penalties for violation; role of IP in Pharmaceutical industry.

b. Trade related aspects of intellectual property rights

Intellectual property and international trade; Concept behind WTO (World Trade

Organization), WIPO (World Intellectual Property Organization), TRIPS (Trade

Related Intellectual Property Rights), and GATS (General Agreement on Trade in

Services); Protection of plant and animal genetic resources; Drug related IPR issues;

Status in India and other developing countries; case studies and examples; TRIPS

issues on herbal drugs.

09 Hrs

REFERENCES

1. Biological standardization by J.H. Burn D.J. Finney and I.G. Goodwin

2. Indian Pharmacopeia and other Pharmacopeias

3. Screening methods in Pharmacology by Robert Turner. A

4. Evaluation of drugs activities by Laurence and Bachrach

5. Methods in Pharmacology by Arnold Schwartz.

6. Selected topics on the experimental pharmacology by Usha G.Karnal Dadkar, N.K and

Seth, U.K

7. Fundamentals of experimental Pharmacology by M.N.Ghosh

8. Pharmacological experiment on intact preparations by Churchill Livingstone

9. Drug discovery and Evaluation by Vogel H.G.

10. Animal models in toxicology by Shyane Cox Gad and Christopher .P Chengellis.

11. The UFAW hand book on the care and management of laboratory animals by UFAW.

12. Principles and methods of toxicology by Hayes.

13. CRC Hand book of toxicology by Derelanko and Holinger.

14. Intellectual Property rights, The WTO Intellectual property Rights and their Knowledge

Economy by Keith. E. Maskus,

JOURNALS

1. Indian Journal of Pharmacology.

2. Indian Journal of Physiology and Pharmacology

3. Indian Journal of Experimental Biology.

4. Pharmacological research.

5. Journal of Gastroenterology.

96

Pharmacological and Toxicological Screening Methods (Practicals) 75Hrs

1. Experiments on CNS: General screening methods of CNS Stimulants and depressants,

anxiogenics and anxiolytics, amnestics and nootropics, anticonvulsants, analgesics and

anti-inflammatory agents (both acute and chronic models).

2. Drug acting on gastro intestinal tract: General screening methods for the anti ulcer activity,

intestinal motility and antidiarrheal.

3. Experiments on local anesthetics: General methods for evaluating local anesthetic activity.

4. Experiments on general pharmacology: Enzyme induction activity, drug dependence and

withdrawal effects.

5. Experiments on diuretics: General screening methods evaluating the diuretic activity.

6. Experiments on cardiovascular pharmacology: Study of effect of drugs on rat BP and ECG

7. Endocrine pharmacology: Screening of anti-diabetic and hepato-protective drugs.

8. Experiments on chemotherapy: In vitro anti microbial screening, anticancer screening

9. Experiments on toxicology: Oral and dermal acute toxicity tests

10. Basics in histopathology methods

97

Paper- IV

Drug Design and Molecular Pharmacology (Theory)

Scope

The subject imparts a fundamental knowledge on the structure and functions of receptors at

their molecular level which are very much essential in Drug Design. The topic on gene

therapy, molecular pharmacology helps the student to upgrade their knowledge as per need of

drug discovery and development.

Objectives

Upon completion of the course the student shall be able to,

describe the molecular level drug receptor interactions and their importance in drug

development.

describe the various drug discovery and development programme

learn the applicability of molecular pharmacology in drug development process.

know the modern approaches for drug discovery such as proteomics and genomics. .

THEORY 75 HOURS

1. Drug receptor theory

Receptors: signal transduction through cytoplasmic secondary messengers, receptor

regulation. Methods of receptor isolation and characterization. Concept of receptors

theories, drug receptor interaction, forces involved in drug receptor interaction.

Receptor polymorphism and dimerization and its importance in drug design.

12 Hrs

2. Physico chemical properties in relation to biological action and drug design.

a. Complex of events between drug administration and drug action

b. Solubility and partition coefficient.

c. Rational drug design.

d. Selected physicochemical properties like isosterism, steric behavior, Ionization,

hydrogen bonding, chelation, oxidation- reduction potential, surface actions.

07 Hrs

3. Guidelines for drug and analog drug design:

a. Basic considerations of drug design, de-novo drug design, lead seeking methods

rational drug design.

b. Structural factors in drug design.

c. Prodrug concepts.

07 Hrs

4. Principles of computer aided drug design and fundamentals of QSAR

objectives

07 Hrs

5. Drug discovery and development

a. New approaches to drug discovery: Combinatorial chemistry,

Pharmacogenomics, Proteonomics, Array technology and High throughput

Screening.

b. Drug development programme: Pharmacokinetic and Pharmacodynamic

approaches

c. Guidelines to introduce a new drug in US and India (IND, NDA and FDA

requirements and Schedule Y and its amendments).

d. Bioethics committee (Role and functions).

e. Human genome project

09 Hrs

6. Molecular Pharmacology:

a. Application of molecular pharmacology to drug design.

b. Introduction to cell structure and function.

c. Pathways of intracellular signal transduction, networks of cellular signal

transduction and biosensors

09 Hrs

98

d. Protein structure prediction and molecular modeling.

7. Gene expression, regulation and gene mapping 05Hrs

8. Recombinant DNA technology

a. Principle methods and its application

b. Monoclonal antibodies for diseases such as diabetes, cancer and

neurodegenerative disorders

05 Hrs

9. Gene therapy

a. Gene transfer technologies (Viral and non viral vectors)

b. Clinical application and recent advances in gene therapy

c. Pharmacodynamics, Pharmacokinetics of protein

d. Immunogenicity of protein therapeutics.

10 Hrs

10. Basic principles of in vitro cell culture techniques 04 Hrs

REFERENCES

1. A guide to chemical basis of drug design by Alfred Rugger

2. Introduction to the principles of drug design by John Smith and HaywelWilliams

3. Burgers medicinal chemistry-The basis of Medicinal Chemistry by Manfred E. Wolf.

4. Computer assisted drug design by Edward Colson (American chemical society –ACS

Symposium series 112).

5. Wilson and Giswolds text book of Organic, Medicinal and Pharmaceutical Chemistry.

6. Goodamn and Gilman‘s-The Pharmacological basis of Therapeutics

7. Medicinal Chemistry- The role of organic chemistry in drug research by S.M.Rroberts and

D.J.Price

8. Principles of Medicinal chemistry by William Foye

9. Vogel‘s text book of practical organic chemistry Y Arthur .I Vogel

10. Current protocols in molecular Biology by Fredrick .M.Ansubel

11. Human molecular genetics by Tomstracham and Andrew P Read.

12. The cell-molecular approach, Geoffrey M.Cooper

13. Bio informatics: genes proteins and computers by Christine Orengo.

14. Gene Therapy, Therapeutic mechanism and strategies by Nancy smith Templeton Danilo

D.Lasic

JOURNALS

1. Gene therapy

2. Cell

3. Molecular Biology and Medicine.

Drug Design and Molecular Pharmacology (Practicals) 75 Hrs

1. Practicals related to physicochemical properties in relation to biological action including

partition coefficient.

2. Cell culture preparation and maintenance of various cell lines.

3. Protein separation and isolation using gel electrophoresis

4. DNA isolation, sequencing and PCR techniques.

5. Estimation of protein and nucleic acids.

6. RNA isolation from yeast.

7. Mutagenicity testing using mouse bone marrow micronucleus test.

8. In vitro cell cultures.

99

M. Pharm - Phytopharmacy and Phytomedicine

Paper Subjects Code


II Advanced Pharmacognosy and Phytochemistry MPM02

III Herbal Drug Development and Standardization MPM03

IV Indian Systems of Medicine MPM04

100

PAPER - I


Scope



IR, HPLC, GC etc.

Objectives





THEORY 75 HOURS



Spectrophotometric titrations, Wood ward – Fiesure rule, Applications of UV-Visible

spectroscopy.

06 Hrs








spectroscopy

08 Hrs






CNMR: Spin spin and spin lattice relaxation

phenomenon. 13

C NMR, 1-D and 2-D NMR, NOESY and COSY techniques,

Interpretation and Applications of NMR spectroscopy.

14 Hrs







10 Hrs

7. Chromatography: Principle, apparatus, instrumentation, chromatographic parameters,

factors affecting resolution and applications of the following:







10 Hrs





06 Hrs

101

9. X ray Crystallography: Production of X rays, Different X ray methods, Bragg‘s law,

Rotating crystal technique, X ray powder technique, Types of crystals, Interpretation of

diffraction patterns and applications of X-ray diffraction.

03 Hrs



11. Radioimmunoassay: Importance, various components, Principle, Different methods,

Limitation and Applications of Radio immuno assay. 03 Hrs


distribution, probability, degree of freedom, standard deviation, correlation, variance,

accuracy, precision, classification of errors, reliability of results, confidence interval,

test for statistical significance – Students T test, F test, Chi square test, Correlation and

regression.

04 Hrs

REFERENCES 1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition,




Nieman, 5th



Denney, 5th





edition, CBS







Edition, Wiley –



Edition,



Dekker Series



30, Elsevier, 2005.

Journals


2. Indian Drugs





102

Modern Analytical Techniques (Practicals) 75Hrs















103

PAPER –II

Advanced Pharmacognosy & Phytochemistry

Scope

To learn and understand the advances in the field of cultivation and production of plant drugs,

neutraceuticals and their evaluation techniques

Objectives

Upon completion of the course, the student shall be able to

know the advances in the cultivation and production of drugs

know the evaluation techniques for the herbal drugs.

THEORY 75 Hour

1. Exogenous and endogenous factors influencing production of drugs, Plant

Growth Regulators and their application in Pharmacy. Disease management

of medicinal and aromatic plants.

06 Hrs

2. Profiles for Commercial Cultivation Technology and Post Harvest Care of

following medicinal plants – Aswagantha, Periwinkle, Medicinal Yams,

Guggal, Neem, Psyllium, Ammimajus, Gymnima, Stevia, Aloe, Saffron,

Forskoli, Artemesia, Guduchi, Kalmegh, Punarnava and Ginseng

12 Hrs

3. Technology for commercial scale cultivation, processing and modern

methods of extraction including SCF, Microwave assisted extraction of

following aromatic plants- Lemon grass, Gerenium, Basil, Palmarosa,

Vetiver, Patchouli, Japaneese Mint, Rose, Hops, Jasmine, Sandal, Dill,

Celery, Anise, Davana and Eucalyptus

12 Hrs

4. Emerging plant drugs: A review and current status of anti-hepatotoxic, anti-

fertility, anti-malarial, anti-hypertisive, anti-biotic, anti-cancer, anti-diabetic

and immunomodulatory plant drugs.

12 Hrs

5. Problem encountered in and prospects of discovering new drugs from plants.

Natural substances as raw materials in drug synthesis. Biomedicinals of

recent discovery

05 Hrs

6. Bio evaluation of herbal drugs.


Hypoglycemic activity



Pscychopharmacological activity

Antiulcer activity


12 Hrs

7. Drugs and pharmaceuticals from marine source ( Marine Pharmacognosy),

with special reference to Cardiovascular, Cytotoxic, Antimicrobial and Anti-

inflammatory compounds.

04 Hrs

8. Herbal Neutraceuticals, Herbal Cosmetics and Herbal Teas. Manufacture,

Packaging and approach to quality control aspects including pesticide

residue, Heavy Metal content, Microbial contamination and GMP for Herbal

drug formulations, Standardization of herbal raw material/extracts as per

WHO /CCMP guidelines

08 Hrs

9. Pharmaceutical aids: Profile for manufacture and commerce of papain,

pectin. Pharmaceutical gums, starch, absorbent cotton and gelatin 04 Hrs

104

REFERENCES 1. Cultivation of medicinal and aromatic crops, 1st edition, by AA Farooqui and B.S.

Sreeramu. University Press, 2001.

2. Medicinal Plants of India, 1st edition, by S.N. Yoganarasimhan, Interlilne Publishing

Pvt. Ltd.. 2000.

3. Medicinal natural products (a biosynthetic approach), 1st edition, by Paul M.

Dewick, John Wiley & Sons Ltd., England, 1998.

4. Natural Products from Plants, 1st edition, by Peter B. Kaufman, CRC Press, New

York, 1998

5. Glimpses of Indian Ethano Pharmacology by P. Pushpangadam. Ulf Nyman.

V.George Tropical Botanic Garden & Research Institute, 1995.

6. Natural products: A lab guide by Raphael Ikan , 2nd Edition, Academic Press 1991

7. Organic Chemistry of Natural Products, Vol. 1&2. Gurdeep R Chatwal.

8. Organic Chemisrty; I.L. Finar - Vol. I & II.

9. Pharmacognosy - G. E. Trease and W.C. Evans. 15th Edition W.B. Saunders

Edinburgh, New York.

10. Pharmacognosy-Tyler, Brady, Robbers

11. Modem Methods of Plant Analysis- Peach & M.V. Tracey, Vol. I&II

12. Phytochemistry -Vol. I to IV. Miller Jan Nostrant Renhold.

13. Recent Advances in Phytochemistry- Vol. 1&4: Scikel Runeckles- Appleton Century

Crofts.

14. Chemistry of Natural Products- Vol. 1 onwards IWPAC.

15. Natural Products Chemistry Nakanishi Golo.

16. The Essential Oils- Ernest Guenther- Robbert E. Kreiaer

17. The Alkaloids chemistry & Physiology- Vols. RH F Manske

18. Introduction to Molecular Phytochemistry- Paul J. Schewer 1973.

19. Chemistry of Marine Natural Products- Paul J. Schewer 1973.

20. Marine Pharmacognosy Ed. by Dean F. Martin & George Padilla.

21. Marine Natural Products-Vol.I to IV.

22. Comparative Phvtochemistry edited by T. Swain.

23. Chemical Plant Taxonomy edited by T. Swain.

24. Cultivation of Medicinal Plants by C.K. Atal & B.M. Kapoor.

25. Cultivation and Utilization of Aromatic Plants By C.K. Atal & B.M. Kapoor

26. Plant Propagation Principles and Practices- Hartmann Kester.

27. Ayurvedic Formulary of India , Government of India.

28. Herbal Drug Iudustry by RD. Choudhary, 1st edition, Eastern Publisher, New

Delhi,1996.

29. Pharmacognosy and Phytochemistry of medicinal plants by Jean Bruneton, Technique

and documentation- Lavoiser, 1995.

30. Text book of Pharmacognosy by C.K.Kokate, Purohit, Ghokhale, 4th edition, Nirali

Prakasshan, 1996.

31. Pharmacognosy and Pharmacobiotechnology by Ashutoshkar, New Age Publications,

New Delhi.

32. Text Book of Pharmacognosy by T.E. Wallis

33. Pharmacopoeial Standards for Ayurvedic Formulations, Central Council for Research

in Ayurvedha and Siddha, New Delhi.

105

Advanced Pharmacognosy & Phytochemistry Practicals 100 hrs

1. Thin layer Chromatography

2. Paper Chromatography

3. Column Chromatography

4. Pharmacognostic evaluation of crude drugs

5. Extractive value determination

6. Ash value determination

7. Moisture content determination

8. Volatile oil content determination

9. Estimation of volatile oil content by UV, spectral analysis

10. Spectroscopic analysis of isolated compounds.

11. Monograph analysis of Crude drugs

12. Monograph analysis of marine products

13. Monograph analysis of volatile oils

14. Evaluation and standardization of nutraceuticals.

15. Bioevaluation of herbal drugs for


Hypoglycemic activity, Diuretic

Cardiac activity



Pscychopharmacological activity

Antifertility activity

Screening of invitro actioxidant activity

Antiulcer activity


16. Quantitative microscopy analysis.

ASSIGNMENTS




106

Paper – III

Herbal Drug Development and Standardization

Scope To make the students understand thoroughly on processing, extraction and drying techniques,

standardization of herbal drugs/formulations, monographs on Indian medicinal plants, herbal

formulation/cosmetics, GMP of Botanicals and Global regulatory requirements for herbal

medicines, bioassay guided fractionation and biomarkers, drug discovery from natural

sources and understanding herb-drug interactions.

Objective

Upon completion of the course, the student shall be able to

know the standardization of herbal drugs/formulations, monographs on Indian

medicinal plants

understanding the drug discovery from natural sources and herb-drug interactions.

.

THEORY 75 HOURS

1. Introduction

Nutraceuticals and Dietary supplements

Definition of herbal medicine, herbal products, herbal drug preparation;

processing of herbal raw material; herb-drug interactions

WHO guidelines on good agricultural and collection practices (GACP) for

medicinal plants.

Role of natural products in drug discovery

Safety of herbals / herbal pharmacovigilance

Understanding mechanisms of action of herbal products

10 Hrs

2. Extraction and Drying techniques Maceration, Percolation, hot continuous extraction, Counter-current

extraction and Supercritical fluid extraction.

Falling film evaporator, rising film evaporator and other concentration

techniques.

Natural drying - Sun drying and Shade drying; Artificial drying- Tray

drying, Spray drying and Freeze drying.

07 Hrs

3. Commerce and quality control of herbal drugs

Indian and International trade in medicinal and aromatic plants; WHO

guidelines for assessment of herbal medicines; Evaluation of identity,

purity and quality of crude drugs; Determination of pesticide residue,

arsenic and heavy metals, microorganisms

Monographs on Indian medicinal plants and extracts

i) In different pharmacopoeia viz., IP, API, USP etc.,

ii) ICMR / ADMA monographs etc.

Markers : Definition, importance in crude drug standardization, examples

of biomarkers, standardization, quality, efficacy and safety requirements &

assessment procedures for botanical dietary supplements as per USFDA.

Bioassay guided fractionation and identification of active constituents

Standardized extracts

Emerging techniques in quality control and standardization of herbal

products viz., DNA fingerprinting, qNMR, biological standardization etc.

18 Hrs

107

4. Drug Discovery

Drug Discovery and Development: Traditional Medicine and

Ethnopharmacology Perspectives

Current status of herbal drugs in india and Challenges in herbal drug

development WHO guidelines on safety monitoring of herbal medicines in

Pharmacovigilance systems

10 Hrs

5. Herbal formulation development

General principles of formulations including physico-chemical properties

like pH, solubility, distribution coefficient, and state of the individual

component added.

Methods involved in preparation of monoherbal and polyherbal

formulations with their merits and demerits : Tablets, capsules, liquid orals

and dermatologics.

Excipients used in herbal formulations, Compatibility studies

Stability studies - Factors affecting the stability of different

formulations. Methods involved in stability testing.

Quality control of finished herbal medicinal products.

Packaging, Labeling and storage of finished products

10 Hrs

6. Herbal Cosmetics

The scope and present status of herbal cosmetics technology

Methods of preparation of herbal cosmetics for skin, hair and dental care.

Determination of shelf life of raw drugs, powdered drugs, extracts,

fractions and finished products.

10 Hrs

7. Global Regulatory status and requirements for herbal medicines

Overview of regulatory requirements for herbal products in USA, Europe,

Australia, Canada and Japan. Details of different segments (drug,

supplements, food and cosmetics) where medicinal plants and extracts are

being used.

Patents and Intellectual property Rights (IPR): Definition, scope and

objectives.

10 Hrs

REFERENCES

1. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New

Delhi.

2. GMP for Botanicals - Regulatory and Quality issues on Phytomedicine by Pulok K

Mukharjee (2003), Ist Edition, Business horizons Robert Verpoorte, New Delhi.

3. Herbal Cosmetics by H.Pande, Asia Pacific Business press, Inc, New Delhi.

4. The complete technology book on herbal perfumes and cosmetics, by H.Pande,

National Institute of Industrial Research, Delhi.

5. Quality control of herbal drugs by Pulok K Mukarjee (2002), Ist Edition, Business

Horizons Pharmaceutical Publisher, New Delhi.

6. PDR for Herbal Medicines (2000), 2nd

Edition, Medicinal Economic Company, New

Jersey.

7. Indian Herbal Pharmacopoeia (2002), Revised Edition, 1DMA, Mumbai.

8. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (1996), 4th

Edition, Nirali Prakashan, New Delhi.

9. Text book of Pharmacognosy and Phytochemistry by Vinod D. RangarI (2002), Part I

& II, Career Publication, Nasik, India.

10. Plant drug analysis by H.Wagner and S.Bladt, 2nd

edition, Springer, Berlin.

108

11. Handbook of Aromatic Plants by S.K.Bhattacharjee, (2005), IInd

Edition,

Aavishkar Publishers, Jaipur, India.

12. Standardization of Botanicals. Testing and extraction methods of medicinal

herbs by V. Rajpal (2004), Vol.I, Eastern Publisher, New Delhi.

13. Herbal Medicines by J.Barnes, L.A. Anderson & J.D.Phillipson (2002), IInd

Edition,

Pharmaceutical Press, UK.

14. Herbal Drugs and Phytopharmaceuticals with reference to German E Monographs by

N.G.Bisset and M.Wichtl, (2001), IInd

Edition, Medpharm Scientific Publishers,

London.

15. The Complete German Commission E Monographs. Therapeutic Guide to

Herbal Medicines by M.Blumenthal (1998), American Botanical Council, Texas.

16. Phytochemical Dictionary. Handbook of Bioactive Compounds from Plants by

J.B.Harborne, (1999), IInd

Edition, Taylor and Francis Ltd, UK.

17. Herbal Medicine. Expanded Commission E Monographs by M.Blumenthal, (2004),

IST Edition, American Botanical Council, IMC, Newton, USA.

18. Drug Formulation Manual by D.P.S.Kohli and D.H.Shah (1998), II Edition, Eastern

Publisher, New Delhi.

19. Formulation and Functions of Cosmetics by J.Stephan (1970), John Wiley & Sons,

Inc, USA.

20. Ayurveda in transition, (2011), Arya vaidya sala, Kottakkal

Journals

1. International Journal of Cosemetic Sciences ( Blackwell Synergy)

2. Indian Drugs (Dr. Patani‘s Scientific & Industrial Research-PSIR, Mumbai)

3. Indian Journal of Pharm. Sciences (Medknow Publications Pvt, Ltd, Mumbai)

4. International Journal of Pharmaceutical Excipients

5. Indian Perfumer (EOAI, New Delhi)

6. Journal of Ethnopharmacology (Elsevier)

7. Journal of Chromatography A, (Elsevier)

8. Flavour and Fragrance Journal (Blackwell Synergy)

9. Journal of Agricultural and Food Chemistry (Elsevier)

10. Journal of Food Chemistry (Elsevier)

Herbal Drug Development and Standardization Practicals

1 Applications of chromatographic techniques such as TLC/HPLC/HPTLC/GC in the

analysis of herbal raw materials/extracts/formulations

2 Preparation and evaluation of mono/poly herbal formulations

3 Preformulation studies of various herbal formulations

4 Formulation and evaluation of some important skin/hair care cosmetic

preparations

5 Development of monograph on selected Indian medicinal plants

6 Standardisation of herbal raw materials/formulations using biomarkers

109

Paper - IV

Indian Systems of Medicine

Scope

To make the students understand thoroughly on principles, preparation of medicines of

various Indian systems of medicine like Ayurveda, Siddha, Homeopathy and Unani. Also

focusing on clinical research of traditional medicines, quality assurance and challenges in

monitoring the safety of herbal medicines.

Objective After completetion of the course, student is able to

understand the basic principles of various Indian systems of medicine

know the clinical research of traditional medicines, Good Manufacturing Practice of

Indian systems of medicine

THEORY 75 HOURS

1. Introduction

Ayurveda, Siddha, Unani and Homoeopathy systems of medicine

Historical development

Fundamental Principles,Merits and demerits, Different dosage forms

Ayurveda : Chronological development of Charak Samhita, Sushrut

Samhita and Kashyapa Samhita. Ayurvedic Pharmacopoeia

Analysis of Ayurvedic Formulations and crude drugs with references to:

Identity, purity and quality of crude drugs. Determination of pesticide

residues, arsenic and heavy metals, microorganisms, microbial load and

identification of aflatoxins.

Siddha: Gunapadam (Siddha Pharmacology), Raw drugs/Dhatu/Jeevam in

siddha system of medicine, Purification process (Suddhi)

16 Hrs

2. Formulation development of various systems of medicine

Salient features of the techniques of preparation of some of the important class

of formulations as per Ayurveda, Siddha, Homeopathy and Unani

Pharmacopoeia and texts.

Parameters involved in the standardization of formulations of ISM. Shelf life

and Stability studies

10 Hrs

3. Sources of drugs in alternative medicines Herbal, Mineral and Animal sources, their collection, purification and

processing.

05 Hrs

4. Schedule T – Good Manufacturing Practice of Indian systems of medicine

Components of GMP (Schedule – T) and its objectives

Infrastructural requirements, working space, storage area, machinery and

equipments, standard operating procedures, health and hygiene, documentation

and records

08 Hrs

5. Naturopathy, Yoga and Aromatherapy practices

a) Naturopathy - Introduction, basic principles and treatment modalities

b) Yoga - Introduction and Streams of Yoga. Asanas, Pranayama,

Meditations and Relaxation techniques

c) Aromatherapy – Introduction, aroma oils for common problems, carrier oils.

12 Hrs

110

6. Nutrition and Balanced diet

Introduction, Nutrients – functions and deficiencies, Food and toxins

07 Hrs

7. WHO guidelines for the clinical research of traditional medicines 05 Hrs

8. Quality assurance and safety Quality assurance in herbal drug industry of GAP, GMP and GLP in traditional

system of medicine. Preparation of documents for new drug application and

export registration.

Challenges in monitoring the safety of herbal medicines : Regulation, quality

assurance and control, National/regional pharmacopoeias

12 Hrs

REFERENCES

1. Ayurvedic Pharmacopoeia (2004), The Controller of Publications, Civil Lines, Govt. of

India, New Delhi.

2. Ayurvedic Formulary of India (2003), 2nd

Revised Edition, Govt. of India, ISM &

Homoeopathy, The Controller of Publications, Civil Lines, Govt. of India, New Delhi.

3. Hand Book on Ayurvedic Medicines by H.Panda National Institute of Industrial

Research, New Delhi.

4. Ayurvedic System of Medicine by Kaviraj Nagendranath Sengupata (1998), 2nd

Revised

Edition, Sri Satguru Publications, New Delhi.

5. Ayurvedic Pharmacopoeia. Formulary of Ayurvedic Medicines (2000), IMCOPS,

Chennai.

6. Siddha Pharmacopoeia. Formulary of Siddha Medicines (2000), IMCOPS, Chennai.

7. Unani Pharmacopoeia. Formulary of Unani Medicines (2004), IMCOPS, Chennai.

8. Homeopathic Pharmacopoeia. Formulary of Homeopathic Medicines (2004), IMCOPS,

Chennai.

9. Siddha Pharmacopoeia by Dr.S. Chidambarathanu pillai, Ist edition, Siddha Medical

Literature Research Centre, Chennai.

10. Homeopathic Pharmacy An introduction & Hand book by Steven B. Kayne (1997),

Churchill Livingstone, New York.

11. Alternative medicine by Dr. K.B. Nangia (2002), APH Publishing Corporation, New

Delhi.

12. Indian Herbal Pharmacopoeia (2002), Revised Edition, 1DMA, Mumbai.

13. British Herbal Pharmacopoeia British (1990), Herbal Medicine Association, UK.

14. GMP for Botanicals - Regulatory and Quality issues on Phytomedicine by Pulok K

Mukharjee (2003), First edition, Business Horizons, New Delhi.

15. Pharmacopoeial Standards of Herbal Drugs by C.R.Karnica (1994), First edition, India

Book Centre, New Delhi.

16. Indian System of Medicine and Homeopathy in India (2001), Planning and Evaluation

Cell, Govt.of India, New Delhi.

17. Pharmacopoeial Standards for Ayurvedic Formulations (1994), Revised Edition, Central

Council for Research in Ayurveda and Siddha, Govt.of India, New Delhi.

18. Testing for Toxicity by J.W. Gorrod (1981), Taylor & Francis Ltd, UK.

21. Practical Nature Cure by Acharya and Lakshmana Sarma (1990), Ist Edi, The Nature

Cure Publishing House, Pudukkttai, TN.

22. Philosophy of Nature Cure by Hendry Lindlhar (1999), The Nature Cure Publishing

Company, South Asland, Chicago.

23. Naturopathy Pocket Reference Digest by Geddu & Grosset (1999), The Nature Cure

Publishing Company, South Asland, Chicago.

24. Essential of Food and Nutrition by Swaminathan (1999), Bappco, Bangalore.

111

25. Clinical Dietitics and Nutrition by F.P. Antia (1997), 4th

Edi, Oxford Universith

Press, Delhi.

26. All you wanted to know about Aromatherapy by Lalitha Sharma (2000), Sterling

Publishers Pvt Ltd, Chennai.

27. Lights on Yoga by Bixs Iyengar (2003), Revised Edition, Harper Collins Publishers,

India.

28. Yoga- The Science of Holistic Living by V.K.Yoga (2005), Vivekananda Yoga

Prakashna Publishing, Bangalore.

29. Yoga Technician by Manohar and Gharote (1999), The Lonavala Yoga Institute,

Bihar, India.

30. Ayurveda in transition, (2011), Arya vaidya sala, Kottakkal.

Journals

1. The Journal of Alternative and Complementary Medicine (Mary Ann Liebert, Inc,

New Rochelle, NY 10801)

2. Journal of Nutraceuticals (Haworthpress)

3. Asian Journal of Traditional Medicines (Asiamed Publishing House, Hong Kong)

4. Journal of Traditional Medicines (Science Links, Japan)

5. International Journal of Ayurveda, Yoga, Naturapathy, Unani, Siddha,

Homeopathy (AYUSH) and other Traditional/Alternative System of Medicine.

6. American Journal of Clinical Nutrition (American College of Nutrition publisher).

Indian Systems of Medicine Practicals

1 Preparation and standardization of various simple dosage forms from Ayurvedic,

siddha, homoeopathy and Unani formulary.

2 Preparation of certain Aromatherapy formulations.

113

M. Pharm- Pharmacy Practice

Paper Subject Code

I Clinical Pharmacy Practice MPP01

II Pharmacotherapeutics-I MPP02

III Pharmacotherapeutics-II MPP03

IV Hospital, Community Pharmacy &

Clinical Research MPP04

114

PAPER I

Clinical Pharmacy Practice

Scope

This course is designed to impart the basic knowledge and skills that are required to practice

pharmacy including the provision of pharmaceutical care services to both healthcare

professionals and patients in clinical settings.

Objectives

Upon completion of this course it is expected that students will be able to:

Understand the elements of pharmaceutical care and provide comprehensive patient

care services

Interpret the laboratory results to aid the clinical diagnosis of various disorders

Provide integrated, critically analyzed drug and poison information to enable

healthcare professionals in the efficient patient management

Understand the concept and practice of the quality use of medicines

LECTUREWISE PROGRAMME:

THEORY 75 HOURS

1. Introduction to Clinical Pharmacy

Definition, evolution and scope of clinical pharmacy 1 Hr

International and national scenario of clinical pharmacy practice 1 Hr

Pharmaceutical care 2 Hrs

04 Hrs

2. Clinical Pharmacy Services

Ward round participation 2 Hrs

Drug therapy review (Drug therapy monitoring including medication order

review, chart endorsement, clinical review and pharmacist interventions)

7 Hrs

Patient medication history interview 2 Hrs

Basic concept of medicine and poison information services 1 Hr

Basic concept of pharmacovigilance 1 Hr

Patient medication counselling 3 Hrs

Drug utilisation evaluation 3 Hrs

Quality assurance of clinical pharmacy services 2 Hrs

21 Hrs

3. Patient Data Analysis

Patient Data & Practice Skills 5 Hrs

Patient's case history - its structure and significances in drug therapy

management 1 Hr

Common medical abbreviations and terminologies used in clinical practice

1 Hr

Communication skills: Verbal and non-verbal communications, its

applications in patient care services. 3 Hrs

Lab Data Interpretation

Haematological tests 1 Hr

Renal function tests 1 Hr

Liver function tests 1 Hr

Tests associated with cardiac disorders 2 Hrs

Pulmonary function tests 1 Hr

15 Hrs

10 Hrs

115

Thyroid function tests 1 Hr

Fluid and electrolyte balance 2 Hrs

Microbiological culture sensitivity tests 1 Hr

4. Medicine & Poison Information Services

Medicine Information Service 6 Hrs

Definition, need for and medicine information resources 1 Hr

Systematic approach in answering medicine information queries 2 Hrs

Preparation of verbal and written response 1 Hr

Establishing a drug information centre 2 Hrs

Poison Information Service 4 Hrs

Definition, need, organization and functions of poison information centre

4 Hrs

10 Hrs

5. Quality Use of Medicines

Evidence Based Medicine 3 Hrs

Definition, concept of evidence based medicine 1 Hr

Approach and practice of evidence based medicine in clinical settings 2 Hrs

Essential Drug 3 Hrs

Definition, need, concept of essential drug 1 Hr

National essential drug policy and list 2 Hrs

Rational Drug Use 3 Hrs

Definition, concept and need for rational drug use 1 Hr

Rational drug prescribing 1 Hr

Role of pharmacist in rational drug use 1 Hr

Prescribing guidelines 4 Hrs

Pediatric prescribing 1 Hr

Geriatric prescribing 2 Hrs

Prescribing in pregnancy and lactation 1 Hr

Pharmacovigilance 8 Hrs

Definition, aims and need for pharmacovigilance 1 Hr

Types, predisposing factors and mechanism of adverse drug reactions

(ADRs) 1 Hr

Detection, reporting and monitoring of ADRs 2 Hrs

Causality assessment of ADRs 2 Hrs

Management of ADRs 1 Hr

Role of pharmacists in pharmacovigilance 1 Hr

Medication errors 4 Hrs

Definition, categorization and causes of medication errors 1 Hr

Detection and prevention of medication errors 2 Hrs

Role of pharmacist in monitoring and management of medication errors 1 Hr

25 Hrs

116

REFERNCES:

1. Practice Standards and Definitions - The Society of Hospital Pharmacists of

Australia (latest edition)

2. Basic skills in interpreting laboratory data - Scott LT, American Society of Health

System Pharmacists Inc (latest edition)

3. A Textbook of Clinical Pharmacy Practice – Essential concepts and skills –

Parthasarathi G, Karin Nyfort-Hansen and Milap Nahata (latest edition)

4. Relevant review articles from recent medical and pharmaceutical literature.

Journals

1. Pharmaceutical Journal. Royal Pharmaceutical Society,

London

2. Journal of Pharmacy Practice and Research, Society of Hospital Pharmacists of

Australia

3. International Journal of Pharmacy Practice, United

Kingdom

4. Hospital Pharmacist, UK

5. Indian Journal of Hospital Pharmacy

Clinical Pharmacy Practice (Practicals) 75 HOURS

Patient medication history interview, answering drug information questions, patient

medication counseling, participation in ward rounds. Case studies related to laboratory

investigations covering the topics dealt in theory class.

1. Answering drug information questions (Any four) (Queries related to Dosage,

administration, Contraindications, Adverse drug reactions, drug use in pregnancy and

lactation, drug profile, efficacy and safety)

2. Patient medication counseling (Any three) (Common diseases like Diabetes, Asthma,

Hypertension, TB, and COPD)

3. Interpretation of laboratory investigations (Any four) (LFT, Hematology, Thyroid,

Renal, Cardiac enzymes)

4. Detection and assessment of adverse drug reactions and their documentation (Any two)

5. Identification and assessment of medication errors (Any two)

117

Paper – II

Pharmacotherapeutics-I

Scope

To train the students in the drug therapy management of different diseases

To develop the skills in students to identify and resolve any drug related problems

To appreciate the quality use of medicines

Objectives

Upon completion of the course, it is expected that students will be able to:

Describe and explain the rationale for drug therapy

Summarize the therapeutic approach for management of these diseases including

reference to the latest available evidence

Discuss the controversies in drug therapy and evidence based medicine

Discuss the preparation of individualized therapeutic plans based on diagnosis

Identify the patient specific parameters relevant in initiating drug therapy, and

monitoring therapy (including alternatives, time- course of clinical and laboratory

indices of therapeutic response and adverse effect/s)

THEORY 75 HOURS

1. Pathophysiology and pharmacotherapy of diseases associated with

following systems/ diseases

1.1 Cardiovascular system

Hypertension, Congestive cardiac failure, Ischemic Heart

disease, Myocardial infarction, Arrhythmias,

Hyperlipidaemias

15 Hrs

1.2 Respiratory system

Asthma, Chronic obstructive airways disease, Drug

induced pulmonary diseases

06 Hrs

1.3 Haematological diseases

Anaemias, Deep vein thrombosis, Drug induced

haematological disorders

06 Hrs

1.4 Rheumatic diseases

Rheumatoid arthritis, Osteoarthritis, Gout, Systemic lupus

erythematosus

06 Hrs

1.5 Gastrointestinal system

Peptic ulcer diseases, Reflux oesophagitis, Inflammatory

bowel diseases, Hepatitis, Jaundice & Cirrhosis, Diarrhoea

and constipation, Drug-induced liver disease

15 Hrs

1.6 Skin and sexually transmitted diseases

Psoriasis, Eczema and scabies, Syphillis and Gonorrhoea,

Drug related skin reactions

06 Hrs

1.7 Pain management

Pain pathways, Analgesics and NSAIDs, Neuralgias

including post herpetic, trigeminal and glossopharyngeal

neuralgia, Palliative care

06 Hrs

2. Clinical Pharmacokinetics

Clinical Pharmacokinetic models

Physiological determinants of drug clearance and volumes of

15 Hrs

118

distribution

Renal and non-renal clearance

Organ extraction and models of hepatic clearance

Estimation and determinants of bioavailability

Multiple dosing

Calculation of loading and maintenance doses

Dose adjustment in renal failure, hepatic dysfunction, geriatric and

pediatric patients

Therapeutic Drug Monitoring (General aspects)

REFERENCES

1. Clinical Pharmacy and Therapeutics - Roger and Walker, Churchill Livingstone

publication

2. Pharmacotherapy: A Pathophysiologic approach - Joseph T. Dipiro et al. Appleton &

Lange

3. Pathologic basis of disease - Robins SL, W.B.Saunders publication

4. Pathology and therapeutics for Pharmacists: A Basis for Clinical Pharmacy Practice -

Green and Harris, Chapman and Hall publication

5. Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and Wilkins

Publication

6. Applied Therapeutics: The clinical Use of Drugs. Lloyd Young and Koda-Kimble MA

Avery‘s Drug Treatment, 4th Edn, 1997, Adis International Limited.

7. Clinical Pharmacokinetics - Rowland and Tozer, Williams and Wilkins Publication.

8. Biopharmaceutics and Applied Pharmacokinetics - Leon Shargel, Prentice Hall

publication


JOURNALS

1. British Medical Journal

2. Annals of Pharmacotherapy

3. New England Journal of Medicine

4. Lancet

Pharmacotherapeutics - I Practicals

Hospital postings in various departments designed to complement the lectures by providing

practical clinical discussion; attending ward rounds; follow up the progress and changes made

in drug therapy in allotted patients; case presentation upon discharge. Students are required to

maintain a record of cases presented and the same should be submitted at the end of the

course for evaluation. A minimum of 15 cases should be presented and recorded covering

most common diseases. The list of clinical cases should include follow up of the clinical

cases mentioned below from the day of admission till discharge. The same cases should be

entered in their practical records following SOAP [Subjective, Objective, Assessment, Plan]

technique.

1. Hypertension

2. Heart Failure

3. Myocardial Infarction

4. Coronary Heart Disease

5. Asthma

119

6. Chronic Obstructive Pulmonary Disease

7. Anemia

8. Osteoarthritis

9. Rheumatoid arthritis

10. Gout

11. Peptic Ulcer

12. Gastro esophageal reflux disease

13. Hyperlipidaemia

14. Neuralgias

15. Psoriasis

16. Hepatitis

ASSIGNMENTS



THREE assignments [1500 – 2000 words] should be submitted in each semester for

evaluation.

Model Assignments

1. Management of Idiopathic thrombocytic purpura

2. Therapy of Helicobacter pylori infection.

3. Role of oral corticosteroids in Chronic Obstructive Pulmonary Disease

120

Paper – III

Pharmacotherapeutics – II

Scope




Objectives










THEORY 75 HOURS

1. Pathophysiology and pharmacotherapy of diseases associated with

following systems/ diseases

1.1

Renal system

Acute renal failure, Chronic renal failure, Renal dialysis and

transplantation, Drug induced renal disease

08 Hrs

1.2 Endocrine system

Diabetes, Thyroid diseases, Oral contraceptives, Hormone

replacement therapy, Osteoporosis

10 Hrs

1.3 Nervous system

Epilepsy, Parkinson's disease, Stroke and transient ischemic

attacks, Headache

08 Hrs

1.4 Psychiatric disorders

Schizophrenia, Depression, Anxiety & Sleep disorders, Drug

induced psychosis

08 Hrs

1.5 Infectious diseases

General guidelines for the rational use of antibiotics, Meningitis,

Respiratory tract infections, Gastroenteritis, Bacterial

endocarditis, Septicemia, Otitis media, Urinary tract infections,

Tuberculosis, Leprosy, Malaria, Helmenthiasis, HIV and

opportunistic infections, Fungal infections, Rheumatic fever.

24 Hrs

1.6 Ophthalmology

Glaucoma, Eye infections

02 Hrs

1.7 Oncology

General principles of cancer chemotherapy, commonly used cytotoxic

drugs, Chemotherapy of lung cancer, hematological malignancies,

Management of nausea and vomiting

10 Hrs

121

1.8 Immunology

Autoimmunity –Definition, Classification, Mechanism of Autoimmune

disease, pathogenesis of Autoimmunity, Immunoglobulins

05 Hrs

REFERENCES


publication

2. Pharmacotherapy:A Pathophysiologic approach-Joseph T. Dipiro et al. Appleton & Lange


4. Clinical Pharmacy and Therapeutics- Eric T. Herfindal, Williams and Wilkins Publication

5. Applied Therapeutics: The clinical Use of Drugs. Lloyd Young and Koda-Kimble MA

6. Avery‘s Drug Treatment, 4th

Edn, 1997, Adis International Limited.


JOURNALS

1. British Medical Journal

2. Annals of Pharmacotherapy

3. New England Journal of Medicine

Pharmacotherapeutics - II Practicals

Hospital postings in various departments designed to complement the lectures by providing

practical clinical discussion; attending ward rounds; follow up the progress and changes made

in drug therapy in allotted patients; case presentation upon discharge. Students are required to

maintain a record of cases presented and the same should be submitted at the end of the

course for evaluation. A minimum of 15 cases should be presented and recorded covering

most common diseases. The list of clinical cases should include follow up of the clinical

cases mentioned below from the day of admission till discharge. The same cases should be

entered in their practical records following SOAP [Subjective, Objective, Assessment, Plan]

technique.

1. Diabetes type1

2. Diabetes type 2

3. Hypothyroidism

4. Hyperthyroidism

5. Acute renal failure

6. Chronic renal failure

7. Schizophrenia

8. Depression

9. Anxiety

10. Epilepsy

11. Parkinson's disease

12. Stroke

13. Infectious diseases [any five]

ASSIGNMENTS




Model for assignments

1. Management of Multidrug resistant tuberculosis

2. Use of antiplatelet in the secondary prevention of stroke

3. Secondary failure to oral hypoglycemic agents and its management.

122

Paper - IV

Hospital, Community Pharmacy & Clinical Research

Scope

This course is designed to impart basic knowledge and skills that are required for the practice

of pharmacy in both hospital and community settings; and to conceptualize, conduct, manage

and report clinical trials.

Objectives

Upon completion of this course it is expected that students will be able to:

Understand the various drug distribution system

Handle the prescriptions and manage community pharmacies

Conduct various phases of clinical trials

Monitor safety and report to the stakeholders

THEORY 75 HOURS

A. HOSPITAL PHARMACY 15 Hrs

1. The role of the hospital pharmacy department and its relationship to other

hospital departments and staff.

01 Hr

2. Hospital drug policy

Drug Committees, Pharmacy & Therapeutics committee, Infection Control

Committee and Formulary development.

03Hrs

3. Hospital pharmacy management

Staff (professional and non-professional), Materials (drugs, non-drugs,

consumables), Financial (drug budget, cost centers, sources of revenue,

revenue collection), Policy and planning, Infrastructure requirements

(building, furniture and fittings, specialised equipment, maintenance and

repairs), Workload statistics

03 Hrs

4. Organisation of hospital pharmacy services

4.1 Drug distribution

Purchasing, Warehousing (storage conditions, expiry date control, recycling of

drugs, stocktaking, drug recalls), Drug distribution methods (ward stock,

individual patient dispensing, unit dose), Specific requirements for inpatients,

outpatients, Casualty/Emergency, Operation Theatres, ICU/CCU, Drugs of

dependence, Hospital waste management

04 Hrs

4.2 Drug stores management

Organization of Drug Store, Purchase and Procurement, Inventory control

(Principles, methods of inventory control) and stores management.

04 Hrs

B. COMMUNITY PHARMACY 15 Hrs

1. The role of the community pharmacy and its relationship to other local health

care providers and services to nursing homes and clinics

01 Hr

2. Prescribed medication order - interpretation and legal requirements

Communication skills - communication with prescribers and patients

03 Hrs

3. Over-the-counter (OTC) sales

Rational use of common OTC medications (Vitamins and tonics, iron

preparations, analgesics, NSAIDs, cough mixtures, anti-diarrhoeal

preparations)

02 Hrs

4. Primary health care in community pharmacy

Family planning, First aid, Smoking cessation, Health Screening programs

04 Hrs

123

5. Community pharmacy management

Financial, materials, staff, infrastructure requirements, drug information

resources, computers

03 Hrs

6. Education and training

Training of technical staff, Training and continuing education for pharmacists,

Pharmacy students, Medical staff and students, Nursing staff and students,

Formal and informal meetings and lectures, Drug and therapeutics newsletter.

02 Hrs

C. CLINICAL RESEARCH 30 Hrs

1. Introduction to Clinical Research

Definitions and terminology used in clinical trials

Historical development in clinical research practice

Drug development process

03 Hrs

2. Research Design Methods

Planning and execution of clinical trials

Various Phases of clinical trials

Bioavailability and Bioequivalence studies

Randomization techniques (Simple randomization, restricted

randomization, blocking method and stratification)

Types of research designs based on Controlling Method (Experimental,

Quasi experimental, and Observational methods) Time Sequences

(Prospective and Retrospective), Sampling methods (Cohort study, case

Control study and cross sectional study)

Health outcome measures (Clinical & Physiological, Humanistic and

economic)

14 Hrs

3. Ethics and Guidelines in Biomedical Research

Ethical Issues in Biomedical Research – Principles of ethics in biomedical

research

Ethical committee [institutional review board] - its constitution and

functions

03 Hrs

4. Clinical research

Roles and responsibilities of clinical trial personnel

Designing of clinical trial documents

Trial report generation

Medical Writing and Ethics of publication

10 Hrs

5. Biostatistics

Frequency distribution : Definition, Types of frequency distribution

Measures of central tendency : Mean , Median

Measures of Dispersion: Standard deviation, Application in clinical studies

Correlation and Regression : Karl Pearson‘s Coefficient of correlation,

Regression, Regression Equations, Standard error of regression

Probability : Definition, Binomial and Poisson‘s distribution

Population and Sample: Definition, Sampling, Essence of sampling, Types

of sampling , Type-I Error, Type-II Error, Hypothesis, Sample size, tests of

significance

Parametric tests: t-test between Population and sample, Pooled t-test, Paired

t-test, One way ANOVA, Two way ANOVA

Non-Parametric tests: Chi-square test, Wilcoxon Signed rank test, Wilcoxon

Rank sum Test, Mann Whitney - U- test, Kruskal Wallis test

15 Hrs

124

REFERENCES 1. Hospital Pharmacy - Hassan WE. Lec and Febiger publication.

2. Textbook of hospital pharmacy - Allwood MC and Blackwell.

3. Avery‘s Drug Treatment, 4th Edn, 1997, Adis International Limited.

4. Remington Pharmaceutical Sciences,

5. Handbook of clinical research. Julia Lloyd and Ann Raven Ed. Churchill Livingstone c.

6. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and

Haynes.

7. Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for

Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health;

2001.

8. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council

of Medical Research, New Delhi.

9. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Gre en,

March 2005, John Wiley and Sons.

10. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second

Edition, Jan 2000, Wiley Publications.

11. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton 3rd and

4thedition, publisher Marcel Dekker Inc. Newyork.

12. Biostatistics- The bare essentials. Geoffrey R Norman, David L Streiner, 3rd edition,

BC Decker Inc, Hamilton, Ontario


JOURNALS 1. Hospital Pharmacist, U.K.

2. Indian Journal of Hospital Pharmacy

Hospital, Community Pharmacy & Clinical Research (Practicals)

Assignments for Community Pharmacy 1. Critical study of two community pharmacies in the neighborhood for schedule M

compliance.

2. Comparison of prescription handling in two community pharmacies.

3. Audit of OTC sales over a 24 hour period in a local community pharmacy

4. Role of community pharmacists in health education, family planning, first aid,

smoking cessation screening programmes, immunisation, etc.

5. Finance and material management in community pharmacies.

6. Critical study of two community pharmacies in large hospitals.

7. Code of ethics for community pharmacies.

8. Summary of the advice and recommendations which should be provided to the

following customers at a community pharmacy

A 57 year old woman who requests a cough mixture. She has no other

associated symptoms, and is being treated for diabetes and hypertension.

A young mother requesting an anti-diarrhoeal medication for her 18 month old

son

A patient with confirmed anaemia who has been advised by their Doctor to

take GlobacTM

A 25 year old man who wishes to purchase medication for temporary relief of

myalgia and fever

125

Assignments for Hospital Pharmacy

1. You have been asked to establish a drug information center in a 1200 bed teaching

hospital. Prepare a written report for the hospital‘s administration summarizing the

resources you will need to do this, including a budget for both initial and ongoing

expenditure.

2. Select a new drug, which has recently been marketed in India for the first time.

Prepare a report for a hospital‘s Drug and Therapeutics Committee, and make a case

either for or against the addition of this new drug on to the hospital‘s formulary.

Issues, which you may need to cover, include the drug‘s pharmacology, its clinical

use, the opinions of relevant hospital consultants and a cost comparison with existing

therapies for the same condition for which the new drug is indicated.

3. Describe and evaluate the layout and workflow patterns in the dispensary of a local

hospital. Include in your report any improvements, which you would recommend to

achieve more efficient work practices.

4. Examine and report on the drug distribution methods used in a local hospital.

5. Prepare one Inventory for the following

Drugs and Surgicals, based on ABC and VED Analysis.

a) Injection ASV b) Injection Adrenaline

c) Injection Deriphylline d) Injection Garamycin

e) Bandage cloth, Vasofix f) Disposable Syringes

g) Antacid tablets h) Tablet Erythromycin

i) Vitamin tablets

6. Study the Store Management in Teaching/ District/ local hospitals for the following

aspects.

a) Receipt of Stores b) Storage

c) Issue d) Documentation.

7. Procurements and storage of vaccine, sera and biological preparations in District

Health Office.

8. Assessment of Efficacy of Different Bronchodilators Used in Chronic Obstructive

Pulmonary disease (COPD).

9. Provision and Evaluation of Drug Information Services to General Practitioners of

your City

10. Counseling to in-patients suffering from Asthma, hypertension, diabetes,

Tuberculosis, peptic ulcer disease, anemia and AIDS

11. Development of patient information leaflets using readability and layout and design

scores.

Assignments for Clinical Research

1. Design of Protocol for different types of studies

2. Correspondence procedures for constitution of IRB

3. Designing of informed consent process

4. Designing of CRF

5. Clinical data monitoring

127

M.Pharm – Pharmaceutical Quality Assurance (MQA)

Paper Subject Code

I Modern Analytical Techniques MAT 01

II Quality Control and Quality Assurance MPA 02

III Pharmaceutical Validation MQA 03

IV Pharmaceutical Technology and Quality

Management MQA 04

128

PAPER - I


Scope




Objectives


The analysis of various drugs in single and combination dosage forms

Theoretical and practical skills of the instruments

Interpretation of the NMR, Mass and IR spectra of various organic compounds

THEORY 75 HOURS


associated with UV-Visible spectroscopy, Choice of solvents and solvent

effect, Spectrophotometric titrations, Wood ward – Fiesure rule, Applications

of UV-Visible spectroscopy.

06 Hrs


Quenchers, Instrumentation and Applications of fluorescence

spectrophotometer.

04 Hrs

3. Flame emission spectroscopy and Atomic absorption spectroscopy:

Principle, Instrumentation, Interferences and Applications. 04 Hrs


Instrumentation of Dispersive and Fourier - Transform IR Spectrometer,

Factors affecting vibrational frequencies, ATR-IR, Interpretation and

Applications of IR spectroscopy

08 Hrs


Instrumentation, Solvent requirement in NMR, Relaxation process, NMR

signals in various compounds, Chemical shift, Factors influencing chemical

shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double

resonance, Brief outline of principles of FT-NMR with reference to 13

CNMR:

Spin spin and spin lattice relaxation phenomenon. 13

C NMR, 1-D and 2-D

NMR, NOESY and COSY techniques, Interpretation and Applications of NMR

spectroscopy.

14 Hrs



MALDI, Analyzers of Quadrupole and Time of Flight, Mass fragmentation and

its rules, Fragmentation of important functional groups like alcohols, amines,

carbonyl groups and alkanes, Meta stable ions, Mc Lafferty rearrangement,

Ring rule, Isotopic peaks, Tandem Mass Instruments, Interpretation and

Applications of Mass spectroscopy.

10 Hrs









10 Hrs

129

8. Electrophoresis: Principle, Instrumentation, Working conditions, factors

affecting separation and applications of the following:

a) Paper electrophoresis b) Gel electrophoresis c) Capillary electrophoresis

d) Zone electrophoresis e) Moving boundary electrophoresis f) Iso electric

focusing

06 Hrs

9. X ray Crystallography: Production of X rays, Different X ray methods,

Bragg‘s law, Rotating crystal technique, X ray powder technique, Types of

crystals, Interpretation of diffraction patterns and applications of X-ray

diffraction.

03 Hrs



03 Hrs








04 Hrs

REFERENCES: 1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition,




Nieman, 5th



Denney, 5th





edition, CBS







Edition, Wiley –



Edition,



Dekker Series



30, Elsevier, 2005.

Journals


2. Indian Drugs





130

Modern Analytical Techniques (Practicals)















131

PAPER - II

Quality Control and Quality Assurance

Scope

This course deals with the various aspects of quality control and quality assurance aspects of

pharmaceutical industries. It covers the important aspects like cGMP, QC tests,

documentation, quality certifications, GLP and regulatory affairs.

Objectives

At the completion of this subject it is expected that the student will be able to know:

The cGMP aspects in a pharmaceutical industry

To appreciate the importance of documentation

To understand the scope of quality certifications applicable to pharmaceutical

industries

To understand the responsibilities of QA & QC departments.

THEORY 75 HOURS

1. Definition - Quality control and Quality assurance, concept and philosophy

of TQM, GMP, ICH, Brief study of ICH common technical documents –

Q1-Q11, Quality by design, six sigma concept, ISO 9000 & 14000.

07 Hrs

2. Organization and personnel responsibilities: Training, hygiene and

personal records, drug industry location, design, construction and plant lay

out, maintenance, sanitation, environmental control, utilities and

maintenance of sterile areas, control of contamination and Good

Warehousing Practice.

09 Hrs

3. Equipments and raw materials: Equipments selection, purchase

specifications, maintenance, clean in place, purchase specifications and

maintenance of stores for raw materials, selection of vendors.

07 Hrs

4. Quality control test for containers, closures and secondary packing materials 06 Hrs

5. Document maintenance in pharmaceutical industry: Batch Formula

Record, Master Formula Record, Quality audit reports and documents,

quality reports, distribution records, Common Technical Document and

Drug Master Files, Medical Devices, Electronic Common Technical

Documentation, complaints and evaluation of complaints, Handling of return

goods, recalling and waste disposal.

08 Hrs

6. In process quality control and finished products quality control for

following formulation in pharma industry: tablets, capsules, ointments,

suppositories, creams, parenterals, ophthalmic and surgical products.

08 Hrs

7. Production controls: Written procedures, change control, contamination

control, sterile products, aseptic process control, packaging. 05 Hrs

8. Manufacturing operations and controls: Sanitation of manufacturing

premises, mix-ups and cross contamination, processing of intermediates and

bulk products, packaging operations, IPQC, release of finished product,

process deviations, charge-in of components, time limitations on production,

drug product inspection, expiration dating, calculation of yields, production

record review

10 Hrs

9. GLP: Scope of GLP, Quality assurance unit, SOP, protocols for conduct of

clinical & non clinical testing, control on animal house, report preparation

and documentation.

08 Hrs

10. NABL certification and accreditation procedure, Patent regime and

intellectual property rights. 07 Hrs

=

132

REFERENCES 1. Quality Assurance Guide by organization of Pharmaceutical Procedures of India, 3

rd

revised edition, Volume I & II, Mumbai, 1996.

Good Laboratory Practice Regulations, 2nd

Edition, Sandy Weinberg Vol. 69, Marcel

Dekker Series, 1995.

2. Quality Assurance of Pharmaceuticals- A compedium of Guide lines and Related

materials Vol I & II, 2nd

edition, WHO Publications, 1999.

3. How to Practice GMP‘s – P P Sharma, Vandana Publications, Agra, 1991.

4. The International Pharmacopoeia – vol I, II, III, IV & V - General Methods of

Analysis and Quality specification for Pharmaceutical Substances, Excepients and

Dosage forms, 3rd

edition, WHO, Geneva, 2005.

5. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel Dekker

Series, 1989.

6. ICH guidelines

7. ISO 9000 and total quality management

8. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4th

edition, Susmit

Publishers, 2006.

9. QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000.

10. Good Manufacturing Practices for Pharmaceuticals a plan for total quality control –

Sidney H. Willig, Vol. 52, 3rd

edition, Marcel Dekker Series.

Quality Control and Quality Assurance Practicals


1. In process quality control tests for tablets, capsules, parenterals and creams

2. Quality control tests for secondary packing materials

3. Assay of raw materials as per official monographs

4. Testing of related and foreign substances in drugs and raw materials

5. Planning and design of plant layouts

133

PAPER – III

Pharmaceutical Validation

Scope

The main purpose of the subject is to understand about validation and how it can be applied

to industry and thus to improve the quality of the products. The subject covers the complete

information about validation, types, methodology and application.

Objectives

Upon completion of the subject student shall be able to

Explain the aspect of validation

Carryout validation of manufacturing processes

Apply the knowledge of validation to instruments and equipments

Validate the manufacturing facilities

THEORY 75 HOURS

1. Introduction to Pharmaceutical Validation: Definition, Manufacturing Process

Model, scope of Validation, Advantage of Validation, Organization for Validation,

Validation Master plan, Types of validation, Design Qualification, Installation

Qualification, Operational Qualification & Performance Qualification of facilities. A

Review of Prospective, Concurrent, Retrospective Validation & Revalidation

including the use of Statistical Process Control (SPC).

15 Hrs

2. Planning & Managing a Validation Program including Change Control, Scale-Up and

Post-Approval Changes (SUPAC), Pre Approval Inspections (PAI) & Technology

Transfer Issues

10 Hrs

3. Validation of equipment: Dry Powder Mixers, Fluid Bed and Tray dryers, Tablet

Compression (Machine), Dry Heat Sterilization/Tunnels, Autoclaves, Membrane

filtration, Capsule filling machines, Validation of Integrated lines by media fill test.

Vendor Certification, Utilities Validation - Pharmaceutical Water System & pure

steam, HVAC system, Compressed air.

15 Hrs

4. Process Validation: Prospective, concurrent, retrospective & revalidation, Process

validation of following formulations - Coated tablets, Capsules, Ointment/Creams,

Liquid Orals. Computer System Validation. Validation of security measures for

electronic data processing.

10 Hrs

5. Analytical method validation, Validation of facilities in Sterile and Non-Sterile plant 10 Hrs

6. Cleaning Validation: Cleaning of Equipment, Cleaning of Facilities 06 Hrs

7. General principles for validation of analytical instruments: U.V./Visible

spectrophotometer, FTIR, DSC, GC, HPLC, HPTLC, LC-MS. 05 Hrs

8. Validation of laboratory equipments:Hardness tester, Friability test apparatus, tap

density tester, Disintegration tester, Dissolution test apparatus

04 Hrs

REFERENCES

1. B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and Pharm

Sci. Series, Vol. 129, 3rd Ed., Marcel Dekker Inc., N.Y.

2. The Theory & Practice of Industrial Pharmacy, 3rd edition, Leon Lachman, Herbert

A. Lieberman, Joseph. L. Karig, Varghese Publishing House, Bombay.

3. Validation Master plan by Terveeks or Deeks, Davis Harwood International

publishing.

4. Validation of Aseptic Pharmaceutical Processes, 2nd Edition, by Carleton &

Agalloco, (Marcel Dekker).

5. Michael Levin, Pharmaceutical Process Scale-Up‖, Drugs and Pharm. Sci. Series,

Vol. 157,2nd Ed., Marcel Dekker Inc., N.Y.

134

6. Validation Standard Operating Procedures: A Step by Step Guide for Achieving

Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Syed

Imtiaz Haider

7. Pharmaceutical Equipment Validation: The Ultimate Qualification Handbook, Phillip

A. Cloud, Interpharm Press

8. Validation of Pharmaceutical Processes: Sterile Products, Frederick J. Carlton (Ed.)

and James Agalloco (Ed.), Marcel Dekker, 2nd Ed.

9. Analytical Method validation and Instrument Performance Verification by Churg

Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Interscience.

Pharmaceutical Validation Practicals


1. Validation of following equipment

a. Autoclave b. Hot air oven c. Powder Mixer (Dry) d. Tablet Compression Machine

2. Validation of analytical methods

3. Validation of a processing area

4. Validation of at least two analytical instruments

5. Cleaning validation of one equipment

Validation of atleast two laboratory equipment

135

PAPER – IV

Pharmaceutical Technology and Quality Management

Scope This course is designed to impart fundamental knowledge about quality management

systems and aseptic technology. The subject also discusses about preformulation, hazards,

stability testing and quality risk mangement. It also aids in understanding the process of

auditing and quality evaluation in the pharmaceutical industries.

Objectives At the end of course, students are able

To understand the preformulation techniques with respect to formulation development

To know the aseptic technology and conditions of sterile manufacture

To know the current good manufacturing practices

To understand the quality evalation of products

To carryout the auditing of manufacturing premises

THEORY 75 HOURS

1. Preformulation studies: Introduction, organoleptic properties, purity, impurity profiles,

particle size, shape and surface area. Solubility, Methods to improve solubility of Drugs:

Surfactants & its importance, co-solvency. Techniques for the study of Crystal

properties and polymorphism. Preformulation protocol, Preformulation stability studies.

08 Hrs

2. Aseptic Technology and Sterile Formulations:

Sterile Facility Design requirements (Air, water, Personnel and utilities) Facility

Qualifications, Personnel Qualification - Gowning, Building Management system

(GAMP – 5).

Media Fills – 3 consecutive successful media fills – acceptance criteria. Investigation of

Media fills failure.

Sterile area maintenance – Equipment upkeep, Preventive Maintenance Schedules and

Management of various sterile area equipments (Washing and sterilization, sterile

Filling, Rubber Bung placement, Flip off seal placement, Labelling and secondary

packaging to Final packing operations involved in sterile preparation)

Daily operation management of sterile equipment of autoclave- leak test, steam

penetration study for clothing and porous load. Chemical Indicators and Biological

Indicators and determination of Cold spots in the autoclave. Load selection criteria for

autoclaves. Steam quality testing methods and Limits.

Aseptic Filtration technique – Filter selection and compatibility, Qualification of Filter,

Bubble point testing.

Documentation – Batch Manufacturing Record, Batch Packing Record, Sterilization data

sheet (retention of Washing equipment data and autoclave, Dry Heat Sterilizer or Tunnel

thermographs).

15 Hrs

3. Industrial hazards, safety, pollution control and effluent treatment: Introduction,

Factory act and rules, fundamentals of accident prevention, elements of safety

programme and safety management, electrical hazards, chemicals hazards and

management of over exposure to chemicals, Gas hazards and handling of gases, dust

explosion and its control, Fire prevention and control, Physicochemical measurements of

effluents, BOD, COD, Determination of some contaminants, Effluent treatment

procedure, treatment of some characteristic effluent.

12 Hrs

4. cGMP of Pharmaceutical manufacturing: Evolution and Principles of cGMP,

Schedule-M, WHO-GMP requirements, European Union (EU) and United States Food

and Drug Administration (USFDA) guidelines on Pharmaceutical manufacturing. URS,

FAT, DQ, SAT, IQ, OQ, PQ of machines and equipment. Clean room standards for

different countries and names.

08 Hrs

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136

5. Principles of Drug discovery and development: Introduction, Clinical research

process. Development and informational content for Investigational New Drugs

Application (IND), New Drug Application (NDA), Abbreviated New Drug Application

(ANDA), Supplemental New Drug Application (SNDA), Scale Up Post approval

changes (SUPAC) and Bulk active chemical Post approval changes (BACPAC), Post

marketing surveillance

10 Hrs

6. Quality evaluation and batch release: Change Control, Deviation-(planned and

unplanned), Corrective Action and Preventive Action (CAPA), Handling of non-

conformance, Vendor evaluation process, Out of specification (OOS), batch

reconciliation and finished goods release, Market recalls & Market complaints.

07 Hrs

7. Auditing: Conducting and Handling of internal/Domestic/International Regulatory

Audits/ Customer specific audits /Pre approval inspections, Annual product reviews,

Standard operating procedures – general guidelines

06 Hrs

8. Stability testing guidelines: ICH and WHO guidelines, Photostability studies 05 Hrs

9. Quality risk management: Introduction, risk assessment, risk control, risk review, risk

management tools, HACCP, risk ranking and filtering 04 Hrs

REFERENCES

1. Lachman L Liberman Theory and practice of industrial pharmacy by 3 rd edition

2. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good

manufacturing of pharmaceuticals (A Plan for total quality control) 3rd Edition.

Bhalani publishing house Mumbai.

3. Tablets Vol. I, II, III by Leon Lachman, Herbert A. Liberman, Joseph B. Schwartz,

2nd Edn. (1989) Marcel Dekker Inc. New York.

4. Text book of Bio- Pharmaceutics and clinical Pharmacokinetics by Milo Gibaldi, 3rd

Edn, Lea & Febriger, Philadelphia.

5. Dissolution, Bioavailability and Bio-Equivalence by Abdou H.M, Mack Publishing

company, Eastern Pennsylvania.

6. Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th Edn.(1995)OO2C

Lippincott; Williams and Wilkins A Wolters Kluwer Company, Philadelphia.

7. The Pharmaceutical Sciences; the Pharma Path way ‗Pure and applied Pharmacy‘ by

D. A Sawant, Pragathi Books Pvt Ltd.

8. The process of new drug discovery and development. I and II Edition by Charles G.

Smith, James T and O. Donnell.

Pharmaceutical Technology and Quality Management (Practicals)


1. To study the effect of pH on the solubility of drugs, (1 experiment)

2. Accelerated stability of drugs in solution dosage forms (1 experiment)

3. Effect of pH on the stability of drugs in solution at elevated temperature (1

experiment)

4. Improved solubility of drugs using surfactant systems (1 experiment)

5. Improved solubility of drugs using co-solvency method (1 experiment)

6. Comparative study of marketed products solid, semisolid and parenteral (3

experiments)

7. GMP in three different formulations (Tablets, liquid orals and semi solids)

(2 experiments each)

8. Standard operating procedures- for analytical instrumentation

9. Standard operating procedures- for operating pharmaceutical machinery

10. Standard operating procedures- cleaning process

GC .

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137

M.Pharm – Pharmaceutical Regulatory Affairs

Paper Subject Code

I Pharmaceutical Quality Management MRA01

II Pharmaceutical Regulations in India MRA02

III International Pharmaceutical Regulations – I MRA03

IV International Pharmaceutical Regulations – II MRA04

138

PAPER - I

Pharmaceutical Quality Management

Scope

This course is designed to impart fundamental knowledge on pharmaceutical quality

management. It prepares the students for most basics of good manufacturing practices,

documentation, auditing, validation and quality management in a pharmaceutical industry.

Objectives

Upon the completion of the course, the student shall be able to:

know the current GMP requirements for a pharmaceutical industry;

prepare various documents in relation to manufacturing of dosage forms;

understand various audits and standard certifications by agencies; and

appreciate the importance of pharmaceutical quality management.

THEORY 75 HOURS

1. cGMP of Pharmaceutical manufacturing process: Evolution and Principles

of cGMP, Schedule-M, WHO-GMP requirements, European Union (EU) and

United States Food and Drug Administration (USFDA) guidelines on

Pharmaceutical manufacturing.

08 Hrs

2. Packaging and labeling of dosage forms: Rule 96 of D&C Act 1940, Annex

13 of EU, Packing and Labeling requirements of various regulated and non-

regulated markets for Solids, Liquid Orals, Parenterals and Semisolids,

introduction to data loggers.

08 Hrs

3. Documentation in pharmaceutical industry: Exploratory Product

Development Brief (EPDB) for Drug substance and Drug product, Product

Development Plan (PDP), Product Development Report (PDR), Master

Formula Record, Batch Manufacturing Record and its calculations, Batch

Reconciliation, Batch Packaging Records, Print pack specifications,

Distribution records, Certificate of Analysis (CoA), Site Master File and Drug

Master Files (DMF).

10 Hrs

4. Validation: Types of Validation, Statistical Process Control (SPC), Types of

Qualification, Validation master plan (VMP), Analytical Method Validation.

Validation of utilities, [Compressed air, steam, water systems, Heat Ventilation

and Air conditioning (HVAC)], Cleaning Validation, Validation facilities in

Sterile and Non-Sterile area.

12 Hrs

5. Quality management: Concept of Quality, Total Quality Management, Quality

by design, Six Sigma concept, Out of Specifications (OOS), Change control 10 Hrs

6. Audits and risk management: Types of Audits, Auditors, Auditing strategies

and preparation of audits, Auditing/inspection of manufacturing facilities by

regulatory agencies. Conducting and Handling of audits, Timelines for

audits/inspection, Pre approval inspections, Corrective and Preventive action

(CAPA), Risk Management.

10 Hrs

7. Harmonization of regulatory requirements: The International Conference on

Harmonization (ICH) process, ICH guidelines to establish quality, safety and

efficacy of drug substances and products. Pharmacopoeias, harmonization of

pharmacopoeial standards and stability testing, WHO guidelines.

10 Hrs

8. The International Organization for Standardization (ISO) 9000 series of quality

systems standards, ISO 14000, NABL, GLP

07 Hrs

139

REFERENCES

1. Good Manufacturing Practice Rationale and compliance by John Sharp

2. Pharmaceutical master validation plan: The ultimate guide to FDA,

GMP and GLP Compliance by Syed Imitiaz Haider

3. Pharmaceutical dosage forms: Parenterals Vol-2, II Edition, by Kenneth

EA and Leon Lachman

4. Packaging and Pharmaceuticals and health care products by H.

Lockhart, Frank A. Paine

5. Establishing a CGMP laboratory audit system- A Practical guide by

David M. Bliesner.

6. J.F.Hanlon: Hand book of package engineering :Mac-Grawhill company

7. Good manufacturing practices: A plan total quality control:

S.H.Wilhing, M.M. Tuckerman, S.Hitchings, Marcel Deckker, Inc.

Newyork.

8. Pharmaceutical Process Validation, 3rd Edition, Edited by Robert Nash

and Alfred Wachter, Marcel Dekker

9. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total

Quality Control from Manufacturer to Consumer, Sidney J. Willig,

Marcel Dekker, 5th Ed.

10. Validation of Pharmaceutical Processes: Sterile Products, Frederick J.

Carlton (Ed.) and James Agalloco (Ed.), Marcel Dekker, 2nd Ed.

11. Validation Standard Operating Procedures: A Step by Step Guide for

Achieving Compliance in the Pharmaceutical, Medical Device, and

Biotech Industries, Syed Imtiaz Haider

12. Pharmaceutical Equipment Validation: The Ultimate Qualification

Handbook, Phillip A. Cloud, Interpharm Press

13. Pharmaceutical Quality Assurance by Manohar A. Potdhar, 2nd

edition,

Nirali Prakashan.

Pharmaceutical Quality Management (Practical) (75 Hrs)

Twenty Assignments to be carried out and submitted on the forementioned

theoretical aspects like

1. Validation of equipments like HPLC, Dissolution, UV

spectrophotometer, tablet press

2. Documentation for in process and finished products Quality control

tests for Solid, liquid, Semisolid and Sterile preparations.

3. Preparation of SOPs, Analytical reports (Stability and validation)

4. Protocol preparation for documentation of various types of records

(BMR, MFR, DR)

5. Labeling comparison between brand & generics.

140

PAPER - II

Pharmaceutical Regulations in India

Scope: This course is designed to impart fundamental knowledge on pharmaceutical

regulations in India. It prepares the students for basic regulatory requirements in India such as

approval of drug products for importing, exporting, manufacturing, sale and marketing

authorisation, conducting clinical trials, patent procedure.

Objectives: Upon the completion of the course the student shall be able to:

Know different laws and acts that regulate pharmaceutical industry in India.;

Understand the approval process and regulatory requirements for neutraceuticals

Prepare the drug regulatory approval process and their registration in Indian market;

and

Appreciate Filing and getting approval for a patent in India.

THEORY 75 HOURS

1. Laws and Acts: An introduction of following laws with regard to drug product

design, manufacture and distribution in India (with latest amendments):

a. Drugs and Cosmetics Act 1940 and its rules 1945

b. National Pharmaceutical Pricing Authority (NPPA)

c. Intellectual property rights - Indian patent Act and its rules, Law of

Copyright and Designs, Law of Trademark and Geographical indications

d. Patent Procedure in India

12 Hrs

2. Guidelines for drug testing in animals/ humans

Animal testing: Rationale for conducting studies, CPCSEA Guidelines

Human testing: ICMR guidelines (Transfer of human biological material for

research commercial purpose, Good clinical laboratory practices, stem cell

research and therapy, international collaboration for research, ethical guidelines

for human participants), IRB / IEC structure and function, Pharmacovigilance

requirements – ADR Reporting.

08 Hrs

3. CDSCO (Central Drug Standard Control Organization): Organization,

Responsibilities, and Registration Procedures for approval of drug products.

Approval procedures (clinical trials), timelines for approval, CDSCO guidelines

(Approval of Clinical trials, Indian Common Technical Document, Serious

Adverse Events Reporting, Indian GCP)

10 Hrs

4. Registration Requirements: Forms, Clinical Trial Registration, Test License,

Commercial Import License, Sale License, Manufacture License, Certificate of

Pharmaceutical Product (CoPP)

07 Hrs

5. Submission Regulations: PSUR, Trial material, registration samples, stability

data requirements, license renewal, post approval changes & reporting categories 10 Hrs

6. BA/ BE: Bioavailability and Bioequivalence Requirements, BCS classification of

drugs, Documentation Requirements for Bioequivalence study for export

applications

10 Hrs

7. Regulatory requirements: For import and product registration of New Drugs,

DCGI & RCGM requirements, Generics, Medical Devices, Biologics, Herbals,

Cosmetics & Fixed Dose Combinations, Export of drugs, traditional drugs,

narcotics etc.

10 Hrs

8. FSSAI (Food Safety Standards Authority of India): Introduction, Approval

process and registration requirements for nutraceuticals 08 Hrs

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141

REFERENCES

1. Manual of Patent Practice & Procedure, 3rd

Edition, by The Patent Office of India

2. Patent Failure How Judges, Bureaucrats, and Lawyers put innovators at risk by

James Bessen and Michael J. Meurer

3. Principles and Practice of Clinical Trial Medicine by Richard Chin and Bruce Y.

Lee

4. Ethical Guidelines for Biomedical Research on Human Participants by Indian

Council of Medical Research New delhi 2006.

5. CPCSEA Guidelines for Laboratory Animal Facility by Committee for the

purpose of control and supervision on experiments on animals (CPCSEA)

6. ICH E6 Guideline ― Good Clinical Practice‖ by ICH Harmonised Tripartite

7. Guidance for Industry on Submission of Clinical Trial Application for Evaluating

Safety and Efficacy by CDSCO (Central Drug Standard Control Organisation)

8. Guidance for Industry on Requirement of Chemical & Pharmaceutical

Information including Stability Study Data before approval of clinical trials / BE

studies by CDSCO

9. Guidelines for Import and Manufacture of Medical Devices by CDSCO

10. Guidelines from official website of FSSAI (Food Safety Standards Authority of

India)

11. Encyclopedia of Biopharmaceutical Statistics 2nd Edition, Edited by Shein-

Chung Chow

12. Guidelines from official website of CDSCO

Pharmaceutical Regulations in India (Practicals) 75 Hrs

Twenty Assignments to be carried out and submitted on the aforementioned theoretical

aspects like

Preparation of clinical trial protocol for registering trial in India

Registration for conducting BA/ BE studies in India

Import of medical devices into India

Import of drugs for research and developmental activities

Preparation of regulatory dossier as per Indian CTD format

Registering for different Intellectual Property Rights in India

Registration of a facility for conducting animal studies

Preparation of Product Safety Update Report (PSUR) for an approved product

GMP Audit Requirements as per CDSCO

Preparation and documentation for Indian Patent application

142

PAPER – III

International Pharmaceutical Regulations - I

Scope

This course is designed to impart the fundamental knowledge on the regulatory requirements

for approval of new drugs, drug products, medical devices, biological, biosimilar, herbal

products and nutraceuticals in regulated countries like US, EU, Japan, Australia, UK and

Canada. It prepares the students to learn in detail on the regulatory requirements,

documentation requirements, and registration procedures for marketing the drug products in

regulated countries.

Objectives

Upon completion of the course, the student shall be able to know

process of drug discovery and development and generic product development

process and procedures for conducting clinical trials and its importance

regulatory approval process and registration procedures for drug products in US, EU,

Japan, Australia, UK and Canada

regulatory approval process for Medical Devices, In vitro Diagnostics, biologics,

biosimilars, herbal products and nutraceuticals in US and EU

THEORY 75 HOURS

1. Drug product development: New Drug Discovery and development, Concept of

generics, Generic drug product development, in vitro and in vivo drug product

performance, BA/BE studies and CRO, IB, CMC, Genotoxic impurities.

Regulatory Submissions: Common Technical Document (CTD), eCTD

10 Hrs

2. Clinical trials: Developing clinical trial protocols, Institutional Review Board/

Independent Ethics committee-formation and working procedures, Informed consent-

process and procedures, Health Insurance Portability and Accountability Act (HIPAA)

- A new requirement to clinical study process, GCP obligations of Investigators,

sponsors & Monitors, Importance of Quality Assurance in clinical trials, Managing

and Monitoring clinical trials, European clinical trials (CT) directives- implementation

and update., Pharmacovigilance-safety monitoring in clinical trials.

Regulatory requirements for various markets: PIC guidelines and mutual

recognition system for audits and compliance

12 Hrs

3. USA: Organization and structure of FDA. Federal register and CFR, History and

evolution of FDC act, Hatch Waxman act and Orange book, Regulatory Approval

Process for IND, NDA, ANDA. Regulatory requirements for Orphan drugs and

Combination Products, SUPAC & PMS. Changes to an approved NDA / ANDA.

12 Hrs

4. European Union: Organization of EMA & Marketing Authorization procedures in

EU (CP, DCP, MRP, NP). Eudralex directives for human medicines, Variations &

extensions, IMPD. Requirements for BA/BE studies, Compliance of European

Pharmacopoeia (CEP)/ Certificate of Suitability (CoS)

12 Hrs

5. Japan, Canada, Australia & UK: Organization of the regulatory body, Drug

approval process and types of registration applications. 12 Hrs

6. Medical Devices: Regulatory approval process for Medical Devices and In vitro

Diagnostics in US and EU. CE certification, ISO standards for Medical devices and In

vitro diagnostics. GHTF/ IMDRF

09 Hrs

7. Product approval process: For Biologics, Biotechnology products (biosimilars),

Herbals, and Nutraceuticals in US & EU. 08 Hrs

143

REFERENCES

1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader

Kaufer, Marcel Dekker series, Vol.143

2. The Pharmaceutical Regulatory Process, Edited by Ira R. Berry Marcel Dekker

Series,Vol.144

3. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and

Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol.185

Informa Health care Publishers.

4. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino,

MD, 5th

edition, Drugs and the Pharmaceutical Sciences,Vol.190.

5. Guidebook for drug regulatory submissions-Sandy Weinberg By John Wiley & Sons. Inc.

6. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics

/edited by Douglas J. Pisano, David Mantus.

7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By

Fay A. Rozovsky and Rodney K. Adams

8. HIPAA and Human Subjects Research: A Question and Answer Reference Guide By

Mark Barnes, JD, LLM and Jennifer Kulynych, JD, PhD

9. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin

and Frederick P. Ognibene

10. Drugs: From Discovery to Approval, Second Edition By Rick Ng

11. New Drug Development: A Regulatory Overview, Eighth Edition By Mark Mathieu

12. Pharmaceutical Risk Management By Jeffrey E. F, Wayne L. Pines and Gary H. Slatko

13. Preparation and Maintenance of the IND Application in eCTD Format By William K.S

14. Medical Device Development: A Regulatory Overview By Jonathan S. Kahan

15. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical DevicesBy

John J. Tobin and Gary Walsh

16. Country Specific Guidelines from official websites.

International Pharmaceutical Regulations - I (Practicals) 75 Hrs


aspects like

Preparation of checklist for registration of IND as per ICH CTD format.

Preparation of checklist for registration of NDA as per ICH CTD format.

Preparation of checklist for registration of ANDA as per ICH CTD format.

Case studies on response with scientific rationale to USFDA Warning Letter

Patent challenge / non infringement (Para IV) case studies.

Preparation of Periodic Safety Update Report (PSUR).

Comparison study of DMF system in US and EU

Preparation of an IMPD for EU submission.

Preparation of Clinical Trial Application (CTA) for EU submission

Comparison study of marketing authorization procedures in EU.

Checklist for registration of prescription medicines (Category I & II applications) for

TGA

Checklist for submission of Category III applications (Post approval changes) for TGA

Study of DMF system in Japan

Preparation of submission checklist for Class I, II and III medical devices

Preparation of submission checklist for registration of OTC products

Preparation of submission checklist for registration of Herbal products

Comparison of Clinical Trial Application Requirements of US, EU and Japan of a dosage

form.

144

PAPER – IV

International Pharmaceutical Regulations - II

Scope

This course is designed to impart fundamental knowledge on Regulatory Requirements for

generic drug registration, new drugs and post approval requirements in emerging market (rest

of world countries) like BRICS, CIS,GCC, LATAM, ASEAN*.

* Whereever the regulatory guidelines are available in English

It prepares the students to learn in detail on Regulatory Requirements for generic drug

registration, new drugs and post approval requirements in rest of world countries.

Objectives

Upon the completion of the course the student shall be able to:

know the regulatory Requirements for generic drug registration in emerging market;

carryout the market authorization requirements for generics and post approval

requirements in emerging market;

Understand the registration requirements of emerging market by comparision; and

prepare dossiers for the registration of the products in emerging market.

THEORY 75 HOURS

1. Emerging Markets: Overview, Regulatory Requirements for generic drug

registration, new drugs and post approval requirements in BRICS countries (Brazil,

Russia, India, China, South Africa) and Egypt.

15 Hrs

2. CIS (Commonwealth Independent States): Regulatory pre-requisites related to

Marketing authorization requirements for generics and post approval requirements in

CIS countries i.e. Armenia, Azerbaijan, Belarus, Kazakhstan, Ukraine and

Uzbekistan.

15 Hrs

3. GCC (Gulf Cooperation Council) for Arab states: Regulatory pre-requisites

related to Marketing authorization requirements for generics and post approval

requirements in Saudi Arabia, Bahrain, Kuwait, Oman, Qatar, UAE and Yemen.

15 Hrs

4. LATAM Countries: Regulatory Requirements for registration of new drugs,

generics and post approval requirements in LATAM countries i.e. Argentina, Chile,

Mexico, Costa Rica, Columbia, Peru.

15 Hrs

5. ASEAN (Association of Southeast Asian Nations) member countries: ACTD,

Regulatory Requirements for registration of new drugs, generics and post approval

requirements in ASEAN member countries i.e. Brunei, Malaysia, Singapore,

Thailand and Vietnam.

15 Hrs

REFERENCES

1. Roadmap to an ASEAN economic community Edited by Denis Hew.ISEAS

Publications, Singapore 2005, ISBN981-230-347-2

2. ASEAN, Rodolfo C. Severino, ISEAS Publications, Singapore 2005, ISBN 978-981-

230-750-7

3. Building a Future With Brics: The Next Decade for Offshoring, Mark Kobayashi-

Hillary, Springer

4. Outsourcing to India: The Offshore Advantage, Mark Kobayashi-Hillary, Springer

5. Trade performance and Regional Integration of the CIS Countries, Lev Freinkman,

The world Bank, Washington, DC, ISBN: 0-8212-5896-0

6. Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow's World By

Frederick M. Abbott, Graham Dukes, Maurice Nelson Graham Dukes

145

7. The Gulf Cooperation Council: A Rising Power and Lessons for ASEAN by Linda

Low and Lorraine Carlos Salazar (Nov 22, 2010)

8. Desert Dreams. The Quest for Arab Integration from the Arab Revolt to the Gulf

Cooperation Council by Justin Dargin (Feb 15, 2012)

9. Doing Business in the Asean Countries, Balbir Bhasin, Business Expert Press

ISBN:13:978-1-60649-108-9

10. Realizing the ASEAN Economic Community: A Comprehensive Assessment,

Michael G Plummer (Editor), Chia Siow Yue (Editor), Instute of South east asian

studies, Singapore

11. The Future of Pharma, Brian Smith, Grower publishing ltd England, ISBN-10:

1409430316 | ISBN-13: 978-1409430315

12. Investing in BRIC Countries: Evaluating Risk and Governance in Brazil, Russia,

India, and China, Svetlana Borodina (Author), Oleg Shvyrkov, Mc -Graw- Hill Inc.

USA, ISBN:978-0-07-166406-6

13. Understanding Emerging Markets: Building Business Bric by Brick, Stefano Pelle,

Response Books, New Delhi, ISBN:10:0-7619-3557-6

14. http://www.pharmweb.net/pwmirror/pwk/pharmwebk.html

15. http://www.ijptonline.com/wp-content/uploads/2010/06/Useful-Websites-links.pdf

16. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/ListMRAW

ebsites.pdf

International Pharmaceutical Regulations – II (PRACTICALS) 75 Hrs


aspects like

Registration requirement comparison study in emerging markets (BRICS)

Registration requirement comparison study in CIS countries

Registration requirement comparison study in ASEAN countries

Registration requirement comparison study in LATAM countries

Registration requirement comparison study in GCC countries

http://www.amazon.com/s/ref=ntt_athr_dp_sr_1?_encoding=UTF8&sort=relevancerank&search-alias=books&ie=UTF8&field-author=Brian%20Smith

http://www.pharmweb.net/pwmirror/pwk/pharmwebk.html

http://www.ijptonline.com/wp-content/uploads/2010/06/Useful-Websites-links.pdf

http://www.who.int/medicines/areas/quality_safety/regulation_legislation/ListMRAWebsites.pdf

http://www.who.int/medicines/areas/quality_safety/regulation_legislation/ListMRAWebsites.pdf

147

M. Pharm – Clinical Practice and Research

Paper Subject Code

I Clinical Pharmacy Practice MPP01

II Pharmacotherapeutics MCP02

III Clinical Research MCP03

IV Clinical Development Guidelines &

Regulations

MCP04

V Research Methodology & Biostatistics MCP05

148

PAPER I

Clinical Pharmacy Practice

Scope

This course is designed to impart the basic knowledge and skills that are required to practice

pharmacy including the provision of pharmaceutical care services to both healthcare

professionals and patients in clinical settings.

Objectives

Upon completion of this course it is expected that students will be able to

Understand the elements of pharmaceutical care and provide comprehensive patient care

services

Interpret the laboratory results to aid the clinical diagnosis of various disorders

Provide integrated, critically analyzed drug and poison information to enable healthcare

professionals in the efficient patient management

Understand the concept and practice of the quality use of medicines

THEORY 75HOURS

1 Introduction to Clinical Pharmacy

Definition, evolution and scope of clinical pharmacy 1 Hr

International and national scenario of clinical pharmacy practice 1Hr

Pharmaceutical care 2Hrs

4 Hrs

2 Clinical Pharmacy Services

Ward round participation 2 Hrs

Drug therapy review (Drug therapy monitoring including medication order 7 Hrs

review, chart endorsement, clinical review and pharmacist interventions)

Patient medication history interview 2 Hrs

Basic concept of medicine and poison information services 1 Hr

Basic concept of pharmacovigilance 1 Hr

Patient medication counselling 3 Hrs

Drug utilisation evaluation 3 Hrs

Quality assurance of clinical pharmacy services 2 Hrs

21 Hrs

Patient Data Analysis

Patient Data & Practice Skills 5 Hrs

Patient's case history - its structure and significances in drug therapy management

1Hr

Common medical abbreviations and terminologies used in clinical practice 1Hr

Communication skills: Verbal and non-verbal communications, its applications in

patient care services. 3 Hrs

Lab Data Interpretation

Haematological tests 1 Hr

Renal function tests 1 Hr

Liver function tests 1 Hr

Tests associated with cardiac disorders 2 Hr

Pulmonary function tests 1 Hr

Thyroid function tests 1 Hr

Fluid and electrolyte balance 2 Hr

Microbiological culture sensitivity tests 1 Hr

15 Hrs

10 Hrs

149

3 Medicine & Poison Information Services

Medicine Information Service 6 Hrs

Definition, need for and medicine information resources 1 Hr

Systematic approach in answering medicine information queries 2 Hrs

Preparation of verbal and written response 1Hr

Establishing a drug information centre 2 Hrs

Poison Information Service 4Hrs

Definition, need, organization and functions of poison information centre

10 Hrs

4 Quality Use of Medicines

















Types, predisposing factors and mechanism of adverse drug reactions (ADRs)

1 Hr





Medication errors 4 hrs


Detection and prevention of medication errors 2 Hhrs


25 Hrs

5 Quality Use of Medicines












25 Hrs

150






Types, predisposing factors and mechanism of adverse drug reactions (ADRs)

1 Hr





Medication errors 4 hrs


Detection and prevention of medication errors 2 Hrs


REFERENCES

1. Practice Standards and Definitions - The Society of Hospital Pharmacists of

Australia (latest edition)

2. Basic skills in interpreting laboratory data - Scott LT, American Society of Health

System Pharmacists Inc (latest edition)

3. A Textbook of Clinical Pharmacy Practice – Essential concepts and skills –

Parthasarathi G, Karin Nyfort-Hansen and Milap Nahata (latest edition)


Journals

Pharmaceutical Journal. Royal Pharmaceutical Society, London

Journal of Pharmacy Practice and Research, Society of Hospital Pharmacists of

Australia

International Journal of Pharmacy Practice, United Kingdom

Hospital Pharmacist, UK

Indian Journal of Hospital Pharmacy

Clinical Pharmacy Practice (Practicals) 75 HOURS

Patient medication history interview, answering drug information questions, patient

medication counseling, participation in ward rounds. Case studies related to laboratory

investigations covering the topics dealt in theory class.

1. Answering drug information questions (Any four) (Queries related to Dosage,

administration, Contraindications, Adverse drug reactions, drug use in pregnancy and

lactation, drug profile, efficacy and safety)

2. Patient medication counseling (Any three) (Common diseases like Diabetes, Asthma,

Hypertension, TB, and COPD)

3. Interpretation of laboratory investigations (Any four) (LFT, Hematology, Thyroid,

Renal, Cardiac enzymes)

4. Detection and assessment of adverse drug reactions and their documentation (Any two)

5. Identification and assessment of medication errors (Any two)

151

PAPER II

Pharmacotherapeutics

Scope




Objectives










THEORY 75 HOURS

1. Pharmacotherapy of diseases associated with following systems/ diseases

1.1 Cardiovascular system

Hypertension, Congestive cardiac failure, Ischemic Heart

disease, Myocardial infarction, Arrhythmias, Hyperlipidaemias

14 Hrs

1.2 Respiratory system

Asthma, Chronic obstructive airways disease

04 Hrs

1.3 Haematological diseases

Anaemias, Deep vein thrombosis

03 Hrs

1.4 Rheumatic diseases

Rheumatoid arthritis, Osteoarthritis, Systemic lupus

erythematosus

04 Hrs

1.5 Gastrointestinal system 07 Hrs

Peptic ulcer diseases, Reflux oesophagitis, Inflammatory bowel

diseases, Hepatitis, & Cirrhosis

1.6 Skin and sexually transmitted diseases

Psoriasis, Syphillis, Gonorrhea, Drug related skin reactions

03 Hrs

1.7 Pain management

Drugs used in management of Pain, Neuralgias including post

herpetic, trigeminal and glossopharyngeal neuralgia

03 Hrs

1.8 Renal system

Acute renal failure, Chronic renal failure

04 Hrs

1.9

Endocrine system

Diabetes, Thyroid diseases, Hormone replacement therapy,

Osteoporosis

08 Hrs

1.10 Nervous system

Epilepsy, Parkinson‘s disease, Stroke

04 Hrs

1.11 Psychiatric disorders

Schizophrenia, Depression, Anxiety disorders

04 Hrs

1.12 Infectious diseases 12 Hrs

152

General guidelines for the rational use of antibiotics, Meningitis,

Pneumonia, Gastroenteritis, Septicemia, Urinary tract

infections, Tuberculosis, Malaria, HIV and opportunistic

infections, Fungal infections

1.13 Oncology

General principles of cancer chemotherapy, commonly used

cytotoxic drugs, management of chemotherapy induced nausea

& vomiting,

05 Hrs

REFERENCES


publication

2. Pharmacotherapy: A Pathophysiologic approach - Joseph T. Dipiro et al.

Appleton & Lange


4. Pathology and therapeutics for Pharmacists: A Basis for Clinical Pharmacy

Practice - Green and Harris, Chapman and Hall publication

5. Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and Wilkins

Publication

6. Applied Therapeutics: The clinical Use of Drugs. Lloyd Young and Koda-

Kimble MA Avery‘s Drug Treatment, 4th Edn, 1997, Adis International Limited.

7. Relevant review articles from recent medical and pharmaceutical

literature/journals like

British Medical Journal

Annals of Pharmacotherapy

New England Journal of Medicine

Lancet

Annals of Internal Medicine

Pharmacotherapeutics (Practicals) 75 HOURS

It includes bedside teaching in various departments of hospital designed to

complement the lectures by providing practical clinical discussion. Follow up of progress and

changes made in drug therapy in allotted patients and case presentation upon discharge.

Students are required to maintain a record of cases presented/discussed and the same should

be submitted at the end of the course for evaluation. A minimum of 15 cases should be

presented and recorded covering most common diseases. The list of clinical cases should

include follow up of the clinical cases mentioned below from the day of admission till

discharge. The same cases should be entered in their practical records following SOAP

[Subjective, Objective, Assessment and Plan] technique.

1. Hypertension 2. Heart Failure 3. Myocardial Infarction

4. Coronary Heart Disease 5. Asthma 6. COPD

7. Diabetes 8. Anemia 9. Chronic renal failure

10. Rheumatoid arthritis 11. Stroke 12. Peptic Ulcer

13. GERD 14. Epilepsy 15. Depression

16. Psoriasis 17. Infectious diseases

153

Paper III

Clinical Research

Scope

• An opportunity to learn the different types and designs of clinical trials

• The requirements for conducting clinical trials

• An opportunity to conceptualize, conduct, manage and report clinical trials

Objectives At completion of this paper it is expected that students will be able to (know, do and

appreciate):

Types of clinical trial designs

Responsibilities of key players involved in clinical trials

Site initiation, monitoring and close-out activities

Safety monitoring and reporting in clinical trials

Preparing clinical study reports and reporting in common technical document

Quality control and assurance in conduct of clinical trial

THEORY 75 HOURS

1 Types and Design of Clinical Trials 10 Hrs

Randomized trials and uncontrolled trials

Descriptive, Interventional and Non-interventional Trials

Crossover and factorial designs

Equivalence, non-inferiority and superiority trials

Bioequivalence and bioavailability studies

Blinding in clinical trials(single, double, double-dummy)

2 Clinical Trial Study Team 06 Hrs

Roles and responsibilities of:

o Investigator

o Co-investigator

o Study Coordinator

o Sponsor

o Monitor

o Contract Research Organization

o Site management Organization

o Vendors (central laboratory, translation companies, logistics)

3 Clinical Trial Documents 12 Hrs

Guidelines to the preparation of documents

Preparation of synopsis and protocols

Preparation of Investigator Brochure

Preparation of Informed Consent Document

Preparation of case report forms

Preparation of clinical study reports and summaries

Preparation of contracts and agreements

Preparation of the diary cards

4 Clinical Trial Start-Up Activities 10 Hrs

154

Site Feasibility Studies

Site/Investigator selection

Vendor selection

Pre-study visit

ICF/PIS translation

Investigator meeting

Clinical trial agreement execution

Ethics committee document preparation and submission

Investigational Product procurement and Storage

Filing procedures

o Essential documents for clinical trial

o Trial Master File preparation and maintenance

o Investigator Site File

o Pharmacy File

Site initiation visit

o Conduct, Report and Follow up

5 Clinical Trial Monitoring and Close-Out 10 Hrs

Preparation for monitoring visit

Conduct of monitoring visit

o Review of source documents, CRF, ICF, IP storage, accountability and

reconciliation, Study Procedure, EC communications etc.

o Safety reporting

Monitoring visit reporting and follow-up

Close-Out visit

o Study related documents collection

o Archival requirement

o IP reconciliation and destruction

o Close-Out visit report

6 Audit and Inspections 5 Hrs

Quality Assurance and Quality Control in Clinical Trials

Types of audits

Audit criteria

Audit process

Responsibilities of stake holders in audit process

Audit follow-up and documentation, Audit resolution and Preparing for FDA

inspections

Fraud and misconduct management

7 Data Management Process 12 Hrs

ICH and its impact

Standard Operating Procedures

Collection of Data and their Management prior to Analysis

Data management plan

CRF design considerations

Database design considerations

Study set-up, Data entry, CRF tracking and corrections, Data cleaning

Managing laboratory data

Managing adverse event data

Data transfer and database lock

155

Quality Control and Quality Assurance in CDM

Data mining and warehousing

8 Infrastructure and System Requirement for Data Management 10 Hrs

Clinical data management systems

Electronic data capture systems

Selection and implementation of new systems

System validation and test procedures

Change control

Coding dictionaries

Data migration and archival

REFERENCES 1. Handbook of clinical research. Julia Lloyd and Ann Raven Ed. Churchill Livingstone

c.

2. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and

Haynes.

3. Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for

Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health;

2001.

4. International Conference on Harmonization of Technical requirements for registration

of Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline

for Good Clinical Practice.E6; May 1996.

5. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council

of Medical Research, New Delhi.

6. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green,

March 2005, John Wiley and Sons.

7. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second

Edition, Jan 2000, Wiley Publications.

Clinical Research (PRACTICALS) 75 HOURS

A minimum of 16 exercises should be presented and recorded. The practical will include the

following

Simulated case studies and case studies from ongoing clinical trials, requiring the

students to evaluate the ethical and regulatory issues and provide their assessments

and actions to be taken

Mock ethical committee meetings

Mock informed consent process

Design and evaluation of site feasibility reports

Preparation for a pre-study site visit

Monitoring of CRFs and source documents from simulated and ongoing clinical trials

to identify discrepancies and discussion of corrective actions

Preparation of monitoring reports

Preparation and evaluation of study documents

156

Paper IV

Clinical Development Guidelines & Regulations

Scope

To learn drug development process specially the phases of clinical trials

To train students on the ethical requirement for conducting clinical trials

Objectives

Upon completion of course it is expected that students will be able to (know, do, and

appreciate)

Drug development process and different phases of clinical trials

History and origin of clinical trials

Regulatory requirements for conducting clinical trials

THEORY 75 Hrs

1 Clinical drug development process

Phase 0 studies

Phase I and subtype studies (single ascending, multiple ascending, dose

escalation, methods, food effect studies, drug – drug interaction, PK end

points

Phase II studies (proof of concept or principle studies to establish efficacy)

Phase III studies (Multi ethnicity, multinational, registration studies)

Phase IV studies (Post marketing authorization studies; pits and practices)

4 Hrs

2 Ethics in Clinical Research:

Historical Perspectives:

o Nuremberg Code, Thalidomide study , Nazis Trials, Tuskegee Syphilis

Study, The Belmont Report

o The declaration of Helsinki

o Origin of International Conference on Harmonization - Good Clinical

Practice (ICH-GCP) guidelines.

The ethics of randomized clinical trials

The role of placebo in clinical trials

Ethics of clinical research in special population

Institutional Review Board/Independent Ethics Committee/Ethics

Committee – composition, roles, responsibilities, review and approval

process and ongoing monitoring of safety data

Data safety monitoring boards.

Responsibilities of sponsor, CRO, and investigator in ethical conduct of

clinical research

8 Hrs

3 Informed Consent Document and Process

Ethical principles governing informed consent process

Structure and content of a Patient Information Sheet

Structure and content of an Informed Consent Form

The informed consent process and documentation

3 Hrs

4 Clinical Research Related Guidelines

Good Clinical Practice Guidelines (ICH GCP E6)

Indian GCP Guidelines

ICMR Ethical Guidelines for Biomedical Research

CDSCO guidelines

8 Hrs

157

5 Regulations Governing Clinical Trials

Clinical Research regulations in India – Schedule Y

Clinical trial application requirements in India- IND, ANDA, AADA and

NDA

USFDA regulations to conduct drug studies

o NDA 505(b)(1) of the FD&C Act (Application for approval of a new

drug)

o NDA 505(b)(2) of the FD&C Act (Application for approval of a new

drug that relies, at least in part, on data not developed by the applicant)

o ANDA 505(j) of the FD&C Act (Application for approval of a generic

drug product)

o FDA Guidance for Industry - Acceptance of Foreign Clinical Studies

o FDA Clinical Trials Guidance Document: Good Clinical Practice

Clinical Research regulations in UK – Medicines and Healthcare Products

Regulatory Agency (MHRA)

Clinical Research regulations in Europe (EMEA)

22 Hrs

6 Regulatory Guidance on Efficacy and Safety

ICH Guidance

o E4 – Dose Response Information to support Drug Registration

o E7 – Studies in support of General Population: Geriatrics

o E8 – General Considerations of Clinical Trials,

o E10 – Choice of Control Groups and Related Issues in Clinical Trials,

o E 11 – Clinical Investigation of Medicinal Products in the Pediatric

Population

FDA Guidance

o CFR 21Part 50: Protection of Human Subjects

o CFR 21Part 54: Financial Disclosure by Clinical Investigators

o CFR 21Part 56: Institutional Review Boards

o CFR 21Part 312: IND Application

o CFR 21Part 314: Application for FDA Approval to Market a New Drug

o CFR 21Part 320: Bioavailability and bioequivalence requirements

o CFR 21Part 812: Investigational Device Exemptions

o CFR 21Part 822: Post-market surveillance

o FDA Safety Reporting Requirements for INDs and BA/BE Studies

o FDA Med Watch

o Guidance for Industry: Good Pharmacovigilance Practices and

Pharmacoepidemiologic Assessment

European Guidance

o EU Directives 2001

o EudraLex (EMEA) Volume 3 – Scientific guidelines for medicinal

products for human use

o EU Annual Safety Report (ASR)

o Volume 9A – Pharmacovigilance for Medicinal Products for Human Use

30 Hrs

158

REFERENCES:

1. Reviewing Clinical Trials: A Guide for the Ethics Committee; Johan PE Karlberg and

Marjorie A Speers; Karlberg, Johan Petter Einar, Hong Kong.

2. International Pharmaceutical Product Registration: Aspects of Quality, Safety and

Efficacy; Anthony C. Cartwright; Taylor & Francis Inc., USA.

3. New Drug Approval Process: The Global Challenge; Guarino, Richard A; Marcel

Dekker Inc., NY.

4. FDA regulatory affairs : a guide for prescription drugs, medical devices, and

biologics; Douglas J. Pisano, David Mantus; CRC Press, USA

RECOMMENDED WEBSITES:

1. EU Clinical Research Directive 2001: http://www.eortc.be/services/doc/clinical-eu-

directive-04-april-01.pdf

2. Code of Federal Regulations, FDA:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

3. Guidelines of International Conference on Harmonization:

http://www.ich.org/products/guidelines.html

4. Eudralex Guidelines: http://www.gmpcompliance.info/euguide.htm

5. FDA New Drug Application:

http://www.fda.gov/regulatoryinformation/legislation/FederalFoodDrugandCosmetic

ActFDCAct/FDCActChapterVDrugsandDevices/ucm108125.htm

6. Medicines and Healthcare products Regulatory Agency: http://www.mhra.gov.uk

7. Central Drugs Standard Control Organization Guidance for Industry:

http://cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf

8. ICMR Ethical Guidelines for Biomedical Research:

http://icmr.nic.in/ethical_guidelines.pdf

http://www.eortc.be/services/doc/clinical-eu-directive-04-april-01.pdf

http://www.eortc.be/services/doc/clinical-eu-directive-04-april-01.pdf

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

http://www.ich.org/products/guidelines.html

http://www.gmpcompliance.info/euguide.htm

http://www.fda.gov/regulatoryinformation/legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm108125.htm

http://www.fda.gov/regulatoryinformation/legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm108125.htm

http://www.mhra.gov.uk/

http://cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf

http://icmr.nic.in/ethical_guidelines.pdf

159

Paper V

Research Methodology & Biostatistics

Scope The course is designed to impart knowledge for postgraduate students regarding various

concepts about research methodology and biostatistics to enable them to design a research

protocol with an appropriate methodology and suitable statistics for evaluation of the results.

Objectives

To understand and appreciate research question/s

To know the different methods of research design.

To understand about the measurement of research outcomes

To understand and apply suitable statistics to evaluate the results.

THEORY 75 HOURS

1 Getting Started: The Anatomy and Physiology of Research 1 Hr

What it is made of

How it works

Designing the study

2 Conceiving the Research Question 2 Hrs

Origins of a research question

Characteristics of a good research question

Developing the research question and study plan

3 Choosing Study Subjects 3 Hrs

Basic terms and concepts

Selection criteria

Sampling

Recruitment of study subjects

4 Planning the Measurements: Precision and Accuracy 3 Hrs

Measurement scales

Precision

Accuracy

Other features of measurement approaches

Measurements on stored materials

5 Getting Ready to Estimate Sample Size: Hypothesis and 2 Hrs

Underlying Principle

Hypotheses

Underlying statistical principles

6 Estimating Sample Size and Power 5 Hrs

Sample size techniques for analytical studies and experiments

Other considerations and special issues

Sample size techniques for descriptive studies

What to do when sample size is fixed

Strategies for minimizing sample size and maximizing power

160

How to estimate sample size when there is insufficient information

Common errors to avoid

7 Designing an Observational Study: Cohort Studies 5 Hrs

Prospective cohort studies

Retrospective cohort studies

Nested Case-Control and Case-Cohort studies

Multiple-cohort studies and External Controls

Planning a cohort study

8. Designing an Observational Study: Cross-Sectional and Case- 4 Hrs

Control Studies

Cross sectional studies

Case control studies

Choosing among observational designs

9 Enhancing Causal Inference in Observational Studies 4 Hrs

Spurious associations

Real associations other than cause effect

Coping with confounders in the design phase

Coping with confounders in the analysis phase

10 Designing an Experiment: Clinical Trials 7 Hrs

Selecting the participants

Measuring Baseline variables

Applying the interventions

Follow-up and adherence to the protocol

Measuring the outcomes

Analyzing the results

Alternatives to the randomized blinded trials

11 Randomization in Clinical Trials 3 Hrs

Definition

Types of bias in randomization

o Selection bias

o Accidental bias

Fixed allocation randomization

o Simple randomization

o Block randomization

o Stratified randomization

Adaptive randomization

o Biased coin method

o Baseline adaptive (minimization)

o Outcome adaptive

12 Designing Studies of Medical Tests 6 Hrs

Determining whether a test is useful

Studies of test reproducibility

Studies of the accuracy of tests

161

Studies of the effect of test results on clinical decisions

Studies of feasibility, costs and risks of tests

Studies of the effect of testing on outcomes

Pitfalls in the design or analysis of diagnostic test studies

BIOSTATISTICS

1 Simple Definitions 1 Hr

Observation

Random Variable

Quantitative Variables

Qualitative Variables

Discrete Random Variable

Continuous Random Variable

Population

Sample and Random Sample

Parameter

Statistics

Biostatistics

2 Descriptive Statistics 3 Hrs

Measures of Location

o Mean

o Median

o Mode

o Geometric Mean

Measures of Dispersion

o Range

o Standard Deviation

o Standard Error

o Sample Variance

o Coefficient of Variation

3 Graphical Representation of Data 4 Hrs

Graphs for Qualitative Variables

o Bar Charts

o Pie Charts

o Pictograph

Graphs for Quantitative Variables

o Stem-and-Leaf Plot

o Histogram

o Frequency Polygon

o Box-and-Whiskers Plot

4 Probability Distributions 5 Hrs

Discrete Distributions

o Binomial Distribution

o Poisson Distribution

Continuous Distributions

o Normal Distribution

o Standard Normal Distribution

162

o Student‘s t-Distribution

o Chi-Square Distribution

o F-Distribution

5 Statistical Inference 6 Hrs

Estimation

o Point Estimation

o Confidence Intervals

Hypothesis Testing

o Null and Alternative Hypothesis

o Types of Errors

o Basic Logic of Tests

o Z-Test

o t-Test

o F-test

6 Measures of Association 3 Hrs

Chi-Square Test

Cochran Mantel Haenszel Test

Fisher‘s Exact Test

7 Correlation and Regression 3 Hrs

8 ANOVA 2 Hrs

9 Biostatistics in Epidemiology 3 Hrs

Incidence, Incidence rate,

Prevalence, Prevalence rate,

Absolute risk, Relative Risk

Odds and Odds Ratio

Absolute risk reduction, Relative risk reduction,

Attributable risk, Odd ratio, Confidence interval of odd ratio,

Sensitivity, Specificity

Number needed for treatment

REFERENCES:

1. Pharmaceutical statistics- practical and clinical applications, Sanford Bolton 3rd

edition, publisher Marcel Dekker Inc. NewYork.

2. Drug Information- A Guide for Pharmacists, Patrick M Malone, Karen L Kier, John E

Stanovich, 3rd

edition, McGraw Hill Publications 2006.

3. Designing Clinical Research; Hulley, SB, Cummings SR, Browner WS, Grady DG,

Newman TB; Lippincott Williams & Wilkins.

4. Pharmaceutical Experimental Design; Lewis GA, Mathieu D, Roger Tan Luu Phan;

Marcel Dekker, Inc., USA.

5. Introduction to Statistics in Pharmaceutical Clinical Trials; Durham TA, and Turner

JR; The Pharmaceutical Press, USA.