block- and schedule placement of elective courses...spring 2019 autumn 2019 biopharmaceuticals:...

Block- and schedule placement of elective courses

Elective courses offered to BA (bachelor) and KA (master) students are marked with green. Elective courses only for KA students are marked with blue. Elective courses only for BA students are marked with orange. The number and level of students are given in brackets including reserved seats for students at specific educations (MPS: Master in Pharmaceutical Sciences, MedChem: Master in Medicinal Chemistry, BA chemistry: Bachelor in Chemistry with specialization in Medicinal Chemistry).

Autumn 2018

Block 1 Block 2

A Pharmaceutical modelling Theories and Research Methods in

Social Clinical Pharmacy

Pharmacokinetics and pharmacodynamics

Klinisk Farmaci B

Advanced manufacturing of pharmaceuticals

Biopharmaceuticals: Formulation of peptides and proteins

Methods and procedures in clinical drug development

C Principles and practice of bioanalysis Biopharmaceutics: Aspects of drug

delivery systems design

Biopharmaceuticals: Design and modifications of biomacromolecules

In vitro techniques in biochemistry and pharmacology

Block 3 Block 4

A Pharmacotherapy Practice Intellectual Property Rights and Innovation in Pharmaceutical Sciences

Design, synthesis and reactivity in medicinal and biopharmaceutical chemistry

Contemporary social pharmacy

Advance in Medicinal Chemistry Research

B Design and Analysis of Experiments Radiopharmaceutical Chemistry

Molecular pharmacology Characterization of drug substances and drug delivery systems

Entrepreneurship in pharmaceuticals

C Drug delivery to the central nervous system (CNS)

Neuropharmacology

Pharmacoepidemiology and pharmacovigilance

Computational Medicinal Chemistry

Regulatory Science

http://kurser.ku.dk/course/sfkkil109u

http://kurser.ku.dk/course/sfkkif104u




http://kurser.ku.dk/course/slkkif101u

http://kurser.ku.dk/course/sfkka9041u






Spring 2019

Autumn 2019

Biopharmaceuticals: Protein production and analysis

Blok-og skemagruppeplacering af obligatoriske kandidatkurser i efterår 2018 og foråret 2019 Obligatoriske KA kurser

Block 3 Block 4

A Pharmaceutical Analytical Chemistry (MPS line II)

Research Project in Pharmaceutics and Drug Delivery (15 ECTS MPS line II)

Pharmacology from Physiology to Therapy (15 ECTS MPS line I and III)

B Pharmacology from Physiology to Therapy (15 ECTS MPS line I and III)

Research Project in Pharmaceutics and Drug Delivery (15 ECTS MPS line II)

C Research Project in Pharmaceutics and Drug Delivery (15 ECTS MPS line II)

Obligatoriske KA kurser

Block 1 Block 2

A Pharmaceutical Policy (KA i Farmaci og Farmaceutisk Videnskab)

Advanced Pharmaceutics (KA i Farmaci og Farmaceutisk Videnskab)

Principles of Pharmacology (MPS) Pharmaceutics and drug development (MPS)

B Toxicology and drug safety (KA i Farmaci og Farmaceutisk Videnskab)

Medicinal and biostructural chemistry (alle KA uddannelser på PharmaSchool)

Drug Discovery and development (MPS)

C Pharmaceutics and drug development (MPS)

Københavns Universitet - Kurser

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TEMP0009 Advanced Pharmaceutics

Expand all Volume 2018/2019

Education

MSc Programme in Pharmacy and Pharmaceutical Sciences - compulsory

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmaceutical Sciences (english programme) - elective

Content

The course gives an overview on fundamental principles in advanced pharmaceutics. Advanced

pharmaceutics topics, which will be addressed in the course, encompass (i) release mechanisms,

(ii) pharmaceutical nanotechnology, (iii) biopharmacy, and (iv) manufacturing and quality control

of advanced dosage forms. The first theme covers release mechanisms. This includes immediate

release, controlled release, and targeted and triggered release of drugs. Pharmaceutical

nanotechnology (theme ii) is addressing drug-polymer conjugates, delivery of biopharmaceuticals

(peptides, proteins and nucleic acids), advanced drug delivery systems and delivery of vaccines.

The third theme of the course (biopharmacy) will focus on evaluation of oral dosage forms,

alternative administration routes for delivery of peptides and proteins, and aspects related to the

drug development process in general (decision trees in drug development, PKPD modelling,

regulatory requirements, the Biopharmaceutics Risk Assessment Road Map, personalized drug

delivery, precision medicine and patient centric therapy). The course will also discuss

manufacturing and quality control (theme iv). This includes manufacturing and analytical aspects

of advanced dosage forms, continuous manufacturing, and quality control aspects of advanced

dosage forms.

The overall aim of the course is to prepare the students to be able to select an advanced dosage

form for a given drug, based on knowledge about the physicochemical properties of the drug, the

advanced dosage form and the administration route. In addition, the student should be able to

select methods for manufacturing, evaluation and quality control of advanced dosage forms.

Learning Outcome

At the end of this course, students are expected to be able to:

Knowledge

• Explain, define and summarize current advanced pharmaceutics principles

• Know and have an overview of current advanced pharmaceutics

Skills

• Able to critically identify, discuss and generalize the knowledge gained in advanced

pharmaceutics

• Master the scientific methodologies in the field of advanced pharmaceutics

• Retrieve, assess and debate information on advanced dosage forms

• Communicate complex theoretical knowledge and experimental data

Competences

• Take responsibility and develop lifelong learning skills on advanced dosage forms

• Fundamentally understand the drug development process and the factors that have to be

considered

Literature

Aulton´s Pharmaceutics (AP)

Pharmaceutics, Drug Delivery and Targeting (PDDT)

Selected review articles and original scientific papers

Formal requirements

non.

Recommended Academic Qualifications

A Bachelor in Pharmacy.

The course are organized under the assumption that the courses Pharmaceutics 1 and

Pharmaceutics 2 or similar have been completed.

Teaching and learning methods

The lectures are based on text books, selected review articles and original scientific papers. The

main teaching forms will be lectures, class room teaching, supervised group work and student

presentations. The group work will be based on individual cases of a selected topic of advanced

pharmaceutics. Students will be divided into groups of 4-6 students, and each group will be given

an assignment. The groups meet with the responsible lecturer twice during the group work

period to discuss the group work and to prepare the groups for their presentations. In addition,

the students will be taught in “How to prepare a scientific presentation (oral + poster)” via class

room teaching. The group work will be presented by the students ad either oral or poster

presentations, presented at two conference-style full-day workshops at the end of the block

(referred to as “Conference Day 1 and 2”).

Lectures (16 double lectures)

Classroom teaching (1 lecture)

Supervised groupwork on individual cases

Student presentations

Feedback form

Oral

Individual

Collective

Continuous feedback during the course of the semester

Peer feedback (Students give each other feedback)

Sign up

Self Service at KUnet

Open for credit transfer students and other external students. Apply here:

Credit transfer students:

http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/

Other external students:

http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/

Credit transfer and other external students are welcomed on the course if there are seats available and they have the academic qualifications.

Exam (Continuous assessment)

Credit

7,5 ECTS

Type of assessment

Continuous assessment, 1 hour online per double lecture, ongoing throughout course

Practical oral examination, 16 h under invigilation

Continuous assessment, 1 hour online per double lecture, ongoing throughout the course.

After every double lecture, a set of questions (MCQ) will be made available. The students need to

answer the questions and will be graded as "passed" or "non-passed" Not filling in in time is

"non-passed". At least 80% of the tests have to be passed to pass the course. A single test is

passed when more than 80% is answered correctly.

Student assessment within the group work: Each student will be assessed according to the

following criteria: A) Each student in a group has contributed equally to the group work. B) The

group work has been submitted and presented at Conference Day 1 or 2. C) Each student has

fully attended Conference Day 1 and 2. Each student has actively participated (either in

presentation or as opponent) on Conference Day 1 or 2. Students have passed the group work

assessment only if ALL assessments criteria have been fulfilled.

Exam registration requirements Aid

All aids allowed

Marking scale

passed/not passed



Censorship form

No external censorship

Re-exam

Students have to pass all examination parts in order to pass the course. Failing in any part will

lead to the students having to write a comprehensive report on a subject determined by the

course responsible, followed by an oral exam on the entire course content.

Criteria for exam assesment

To achieve a course certificate the students must be able to:

Knowledge

• Explain, define and summarize current advanced pharmaceutics principles

• Know and have an overview of current advanced pharmaceutics

Skills

• Able to critically identify, discuss and generalize knowledge gained in advanced

pharmaceutics

• Master the scientific methodologies in the field of advanced pharmaceutics

• Retrieve, assess and debate information on advanced dosage forms

• Communicate complex theoretical knowledge and experimental data

Competences

• Take responsibility and develop lifelong learning skills on advanced dosage forms

• Fundamentally understand the drug development process and the factors that have to be

considered

Workload

Category Hours

Exam 16

Lectures 32

Preparation 64

Class Instruction 1

Project work 77

Colloquia 16

Total 206

Course information

Language

English

Course code

TEMP0009

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 2

Schedule

A

Inklusiv fredag i uge 8.

Course capacity

230 students

Continuing and further education Study board

Study Board of Pharmaceutical Sciences

Contracting department

Department of Pharmacy

Course Coordinators

Thomas Rades ([email protected])

Hovedansvarlig

Camilla Foged ([email protected])

Lecturers

Thomas Rades

Camilla Foged

Jukka Rantanen

Anette Müllertz Saved on the 02-01-2018

Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.


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TEMP141202 Biopharmaceutics: Aspects of Drug

Delivery System Design


Education

MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and

cand.scient.pharm) - elective


MSc Programme in Pharmaceutical Sciences (English programme) - elective

Content

The course addresses in detail the aspects of biopharmaceutics in drug delivery.

This includes consideration of not only the drugability of a specific drug molecule for reaching a

specific target, but also links to the developability in relation to the design of a desired drug

delivery system.

Biopharmaceutical aspects are here defined as the interrelation of the drug/drug delivery system

with biological matrices (e.g. blood, saliva, gastro-intestinal fluids, lung-lining fluids, mucus,

epithelia, endothelia) and how this may influence delivery of the drug to exert the desired effect

effects on PK and PD).

Delivery of sufficient amounts of the active pharmaceutical ingredient (API) to therapeutic targets

increasingly require the use of biopharmaceuticals (i.e. peptides, proteins, nucleic acids), but also

small molecule drugs. Combination therapies and/or the application of functionalizing excipients

and drug delivery systems.

The course will in a case-based manner focus on how to asses and in-depth evaluate drug

delivery systems towards a translation from molecule to dosage form.

The course will be be class-room lectures (16x2 lectures; e.g. Tuesdays and Thursdays 8-10)

supplemented with group work and presentations by the students.

Learning Outcome

At the end of the course, students are expected to be able to:

Knowledge

• identify and explain biopharmaceutical aspects in drug research and development (i.e. be

able to consider drugability and developability of drugs/drug delivery systems)

• refere state-of-the-art methodologies for assessment of biopharmaceutical aspects in drug

delivery

Skills

• select and use relevant scientific information in relation to planning and executing the

biopharmaceutical evaluation of a given drug/drug delivery system

• plan, prepare and present (examples of) laboratory protocols

• evaluate experimental data and relate to findings

Literature

1) selected text book material/chapters

2) scientific literature

3) experimental data and protocol examples

Formal requirements

Non.


Lectures, supervised group work and student presentations (written/oral) with peer-reviewing

Feedback form

Oral



Sign up








Credit

7,5 ECTS

Type of assessment

Continuous assessment



To obtain a course certificate the students should:

*Take part in group presentation of written and oral work.

*Take part in group preparation and presentation of a plan for detailed assessment of a selected

drug and drug delivery system with special emphasis on the relevant biopharmaceurtical aspects.

*Participate in peer-review of the work of other groups

*Carry out protocols (s) of laboratory tests

*Participate satisfactorily throughout the course.

Evaluations are done by the course teachers (as "invited evaluation panel").

Aid

All aids allowed

Marking scale

passed/not passed

Censorship form



To obtain a course certificate the students should be able to:

Knowledge

• identify and explain biopharmaceutical aspects in drug research and development (i.e. be

able to consider drugability and developability of drugs/drug delivery systems)

• refere state-of-the-art methodologies for assessment of biopharmaceutical aspects in drug

delivery

Skills

• select and use relevant scientific information in relation to planning and executing the

biopharmaceutical evaluation of a given drug/drug delivery system

• plan, prepare and present (examples of) laboratory protocols

• evaluate experimental data and relate to findings

• outline and briefly explain relevant biopharmaceutical information required to evaluate a

certain drug/drug delivery system

• outline protocol(s) for how to test some of the above in the laboratory

Workload

Category Hours

Preparation 110

Lectures 32

Class Instruction 16

Colloquia 16

Project work 32

Total 206

Course information

Language

English

Course code

TEMP141202

Credit

7,5 ECTS

Level

Part Time Master

Full Degree Master choice

Duration

1 block

Placement

Block 2

Schedule

C And C

Course capacity

60





Course Coordinators

Hanne Mørck Nielsen ([email protected])

Lecturers

Hanne Mørck Nielsen

samt op til 3 andre undervisere fra Institut for Farmaci

Saved on the 22-12-2017


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TEMP00001 Pharmaceutical Modelling


Education

MSc Programme in Pharmacy and Pharmaceutical Sciences (danish programmes cand.pharm

and cand.scient.pharm) - elective



Content

The course focuses on mathematical models for a quantitative understanding of diverse

pharmaceutically relevant problems. This includes models at different scales, both for molecular

and particle level properties, interactions between molecules/particles and their interactions with

the organism. The course will via 'real-life' practical examples provide the students with

knowledge about the theory behind methods used for pharmaceutical modelling and simulation

of system behavior. The students will be provided with input data for the different systems

studied.

In the lectures, the students are introduced to the fundamental principles behind methods in

pharmaceutical modelling. In the exercises, the students get hands-on experience with methods

used in academia and industry and get an opportunity to apply these methods on 'real-life'

problems.

The course begins with a introduction and brush-up on fundamental mathematical tools, building

on the knowledge obtained during the bachelor courses, e.g. physical chemistry. We then apply

and modify computer scripts that model the pharmaceutical systems, and discuss these models

in relation to the literature.

The topics covered in the lectures and exercises are:

• Introduction to basic multivariate calculus and linear algebra

• Introduction to differential equations

• Model optimization

• Multivariate data analysis

• Molecular dynamics

• Image analysis

Visualization of data is an important aspect of the course.

Examples on areas covered in the lectures and exercises are:

• Interatomic forces in biological and crystalline drug systems – molecular dynamics

• Image analysis of digital images from e.g. electron microscopy studies.

• Model optimization against experimental powder diffraction data

• Multivariate methods for process analytical technology, e.g. powder diffraction, Raman and

NIR spectroscopies

Objective

The course is relevant for pharmaceutical research within both drug discovery and drug

development where it is important to:

• Understand the theory behind models on various levels of the drug discovery and

development process

• Get hands-on experience with modern tools in pharmaceutical modelling

• Know the accuracy and applicability of mathematical models

Learning Outcome


Knowledge

• Explain the mathematical principles behind selected methods used

• Be critical to the quality of the data and developed mathematical models

• To link modeling results and experimental work

Skills

• Develop pharmaceutical models

• Evaluate the accuracy of the models

• Have hands-on experience with mathematical and statistical software

Competences

• Apply models in pharmaceutical research and development

• Critically evaluate the usability of diverse computational platforms for pharmaceutical

problems

• Select the appropriate mathematical model to solve problems in pharmaceutical sciences

No prior computer programming knowledge is needed.

Literature

Literature

Munk and Munro: Maths for chemistry. Latest edition.

Lecture notes.

Software

The students will use various types of software, primarily software used in previous courses,

open source software and software used in industry.

Formal requirements

Non.


Teaching is organized on the assumption that students already have acquired knowledge

comparable to the math curriculum on the bachelor level of the pharmacy education. No special

skills for computer programming are needed.


Lectures: 12 hours

Class room exercises: 10 hours

Computer exercises: 20 hours

Project work: 70 hours

Supervision during project work: Guidelines will be available on the course homepage

Mathematical test and oral presentation of group work.

Feedback form

Oral

Individual


Feedback by final exam (In addition to the grade)

Sign up







Exam 1 (Continuous assessment)

Credit

2,5 ECTS

Type of assessment

Course participation


In order to obtain the course certificate the students should:

*Participate satisfactorily throughout the course.

*Complete a mathematical test on the entire curriculum to satisfaction.

*In groups prepare a written work (powerpoint or poster) within one of the four main subjects of

the course.

Marking scale



passed/not passed

Censorship form



To obtain a course certificate the student must be able to:

Knowledge



• Link modeling results and experimental work

Skills




Competences



problems


Exam 2 (Oral examination)

Credit

5 ECTS

Type of assessment

Oral examination, 30 minutes

The oral examination is individual and without preparation.

The oral examination is based on the written group work, that the student has prepared during

the course of teaching.

Aid

Without aids

It is permitted to bring the written work on which the oral examination is based on to the

examination.

Marking scale

7- point grading scale

Censorship form



To achieve the grade 12 the student must be able to:

Knowledge



• Link modeling results and experimental work

Skills




Competences



problems


Workload

Category Hours

Lectures 12

Theory exercises 28

Preparation 70

Project work 70

Exam 20

Guidance 6

Total 206

Course information

Language

English

Course code

TEMP00001

Credit

See exam description

Level

Full Degree Master


Duration

1 block

Placement

Block 1

Schedule

A

Course capacity

54

Continuing and further education

Study board




Course Coordinators

Anders Østergaard Madsen ([email protected])

Lecturers

Anders Østergaard Madsen

Johan Peter Bøtker










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den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige

version.

SFAKB0021U Pharmaceutical Policy Fold alle ud

Årgang 2018/2019

Engelsk titel

Pharmaceutical Policy

Uddannelse

MSc programme in Pharmacy or Pharmaceutical Sciences - compulsory

MSc programme in Pharmaceutical Sciences (english programme) -

elective MSc programme in Medicinal Chemistry - elective

Kursusindhold

The course focuses on the areas of pharmaceutical policy making, regulatory science,

health economics evaluation and health care ethics.

Students work with real world cases applying concepts, theories and tools from various scientific

disciplines to analyze the case.

The main topics of the course are: health care systems, key actors in pharmaceutical policy

making, drug regulatory systems, systems to support rational use of medicines, core ethical

concepts used in health care, ethical aspects of pharmaceuticals and medical devices in

society, economic tools to manage medicines use and costs, prioritization in health care

systems, and health economic evaluation.

Målbeskrivelser

The aim of the course is to facilitate the students’ understanding of pharmaceutical policy

questions on the societal level based on cross-disciplinary, critical and analytical work with real

world cases.

The course should make the student able to argue on real world issues and to analyze underlying

interests, ethical and political standpoints of key actors within the pharmaceutical and medical

device arena. In addition the course should give the student basic knowledge of how health

economics is used in the pharmaceutical policy arena.

Upon completion of the course the student should be able to:

Knowledge

• Classify and describe the general traits of health care systems

• Describe the overall regulatory aspects in the field of pharmaceuticals and medical devices

• Outline regulation, funding, pricing and distribution of medicines in society

• Describe basic concepts in health economics and priority setting in health care

• Describe basic concepts in health care ethics

Skills

• Identify the different actors' interests and how they argue their positions

• Apply concepts to identify political, ethical and health economic aspects of pharmaceutical

policy

• Identify ethical issues in the field of pharmaceuticals and medical devices

• Conduct well-founded ethical argumentation regarding pharmaceutical issues using basic

ethics concepts

• Identify and discuss the relevance of a given health economic evaluation and the outcome

measures used

• Evaluate and discuss the choices made in health economic evaluations

Competencies

• Discuss and synthesize current issues in the field of pharmaceuticals and medical devices

overall, based on both political, economic and ethical/ ideological aspects using relevant

tools and concepts

• Be able to critically evaluate and extract well-balanced conclusions from published health

economic evaluations.

Undervisningsmateriale

Book to be decided.

Scientific literature, media debates, articles, links to homepages, etc. posted on Absalon

Formelle krav

Non.

Anbefalede faglige forudsætninger

The course assumes skills commensurate to a Bachelor in Pharmacy including a course in Social

Pharmacy or equivalent insight into the user perspective on medicines and basic knowledge of

drug utilization statistics.

Undervisningsform

• Lectures and discussion seminars

• Case work in groups and discussion of cases

Feedbackform

Kollektiv

Peerfeedback (studerende giver hinanden feedback)

Tilmelding

Selvbetjeningen på KUnet

Open for credit transfer students and other external students. Apply

here: Credit transfer students:

http://sund.ku.dk/uddannelse/vejledning-information/meritstuderende/


http://sund.ku.dk/uddannelse/efter-og-videreuddannelser/enkeltfag/

Credit transfer and other external students are welcome on the course if there are

available seats and they have the academic qualifications.

Eksamen (SFAKB0021E - skriftlig prøve)

Point

7,5 ECTS

Prøveform

Skriftlig prøve, 6 timer med opsyn.

Written exam, 6 hours of supervision. The exam consists of questions for one or more cases

focusing on the subject areas of policy, ethics and economics. The documents related to the

cases are handed out 24 hours prior to the actual examination via Absalon, while the specific

form of the questions is handed out in the written exam.

Hjælpemidler

Skriftlige hjælpemidler tilladt

There is access to the following, at the exam on Peter Bangs Vej:

• Officepakken (Word, Excel, Onenote og Powerpoint)

• IO2 – the digital pen

• Panoramic Viewer

• Paint

• Calculator – Windows´own

• R – Statistical programme

• ITX MC – multiple choice programme

• Adobe reader

• MathType - formular programme

• Mable

• USB access – for usb stick with notes ect.

Bedømmelsesform

7- trins skala

Censurform

Ekstern censur

Kriterier for bedømmelse

To pass the exam the student must be able

to: Knowledge

• Classify and describe the general traits of health systems

• Describe the overall regulatory aspects in the field of pharmaceuticals and medical devices



• Outline regulation, funding, pricing and distribution of medicines in society

• Basic concepts in health economics and priority setting in health care

• Basic concepts in health care ethics

Skills

• Identify the different actors' interests and how they argue their positions

• Apply concepts to identify political, ethical and health economic aspects of pharmaceutical

policy

• Identify ethical issues in the field of pharmaceuticals and medical devices

• Conduct well-founded ethical argumentation regarding pharmaceutical issues using basic

ethics concepts

• Identify and discuss the relevance of a given health economic evaluation and the outcome

measures used

• Evaluate and discuss the choices made in health economic evaluations

Competencies

• Be able to discuss and synthesize current issues in the field of pharmaceuticals and

medical devices using relevant tools and concepts

• Be able to critically evaluate and extract well-balanced conclusions from published

health economic evaluations.

Arbejdsbelastning

Kategori Timer

Forelæsninger 34

Seminar 16

Øvelser 12

Forberedelse 106

Eksamen 38

I alt 206

Kursusinformation

Sprog

Engelsk

Kursuskode

SFAKB0021U

Point

7,5 ECTS

Niveau

Kandidat

Varighed

1 blok

Placering

Blok 1

Skemagruppe

A (tirs 8-12 + tors 8-17)

Kursuskapacitet

180 students (reserved students at master programmes in Pharmacy or Pharmaceutical

Sciences).

Efter- og videreuddannelse Studienævn

Studienævn for de Farmaceutiske Videnskaber

Udbydende institut

Institut for Farmaci

Kursusansvarlige

Anna Birna Almarsdóttir ([email protected])

Social and Clinical Pharmacy

Study secretary: Malthe Sørensen ([email protected])

Gemt den 03-01-2018



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TEMP181901 Pharmacoepidemiology and

Pharmacovigilance


Education

MSc Programme in Pharmacy or Pharmaceutical Science (danish programmes Cand.Pharm and

Cand.Scient.Pharm) - elective


Content

The principles of pharmacoepidemiology and pharmacovigilance are presented, including the

related processes in the pharmaceutical industry and regulatory authorities. Lectures are

supplemented with group discussions and exercises with calculations in a spreadsheet or

statistical software. During the last weeks of the course, the students will in groups prepare a

project report based on a case scenario where they develop and write up either an

epidemiological study protocol, a risk management plan or a risk/benefit assessment. The written

report is evaluated, presented orally and critically assessed by the other groups. Topics are:

• Introduction to pharmacovigilance

◦ Definitions, background and history

◦ Institutions and individuals involved in pharmacovigilance

◦ Sources of information on drug-related risks

• Pharmacoepidemiological methods

◦ Measures of occurrence and effect

◦ Cohort and case-control study designs

◦ Sources of error, bias and confounding

◦ Data sources, validity and limitations

◦ Analysis of epidemiological studies

◦ Drug utilisation studies and quality indicators of drug use

◦ Post-approval safety studies – protocols and practice

• Spontaneous reporting systems

◦ Individual case safety reports, clinical diagnosis coding and causality assessment

◦ Quantitative signal detection and signal evaluation

• Regulatory aspects of pharmacovigilance

◦ Pharmaceutical industry safety reporting and risk management plans

◦ Good pharmacovigilance practices

◦ Regulatory processes and decisions

◦ Benefit/risk assessment

Learning Outcome

The aim of the course is to give students knowledge about the principles of

pharmacoepidemiology and pharmacovigilance. Additionally, to provide students with an

understanding of the different types of evidence produced by experimental and observational

studies of drug effects, and of the strengths and weaknesses of different study designs and

methods. The students should be able to choose design and data sources that best fit the

purpose of a study, and to critically evaluate published literature on drug safety, efficacy and

effectiveness. They should be able integrate results from safety surveillance and post-approval

studies with other preclinical and clinical safety information.

After completing the course the student is expected to be able to:

Knowledge

• understand pharmacoepidemiological and pharmacovigilance methods used to generate

the evidence for benefit/risk assessments

• understand and explain central pharmacoepidemiological and pharmacovigilance

concepts.

• explain principles of safety surveillance and risk management, including the obligations of

the pharmaceutical industry and the basis for regulatory decisions.

• identify and summarise the limitations of pharmacoepidemiological studies and safety

surveillance systems.

Skills

• describe, analyse and interpret the results of pharmacoepidemiological studies and safety

surveillance.

• assess and discuss the limitations of data and methods in published literature and safety

reports.

• summarise and prioritise safety information obtained with different methods in a

structured way.

• communicate information on safety issues and drug-related risks.

Competences

• independently develop a protocol and plan for a post-authorisation safety study.

• perform a general benefit/risk assessment of a drug, integrating results from studies on

efficacy and safety, data from safety surveillance systems and other information.

• outline a risk management plan for a marketed drug based on information on safety issues

and patterns of use.

Literature

Selected textbook chapters, lecture notes, laws, documents, recommendations, circulars,

guidelines and scientific papers.

Formal requirements

Non.


Course teaching is based on the assumption that students have knowledge corresponding to the

content of the courses Basic Pharmacology, Organ-related Pharmacology, Pharmacotherapy and

Toxicology. For MSc students Principles of Pharmacology and Pharmacology: From Physiology to

Therapy.


Lectures: 40 (45 min.)

Group and classroom discussions: 15 (45 min.)

Case project and report: 70

Feedback form

Oral



Sign up





Other external students: http://healthsciences.ku.dk/education/exchange_guest_students/guest-

students/

Exam (continuous assessment)

Credit

7,5 ECTS

Type of assessment


Written assignment

Course certificate: During the last weeks of the course, the students will in groups prepare a

project report based on a case scenario where they develop and write up either an

epidemiological study protocol, a risk management plan or a risk/benefit assessment. The written

report is evaluated, presented orally and critically assessed by the other groups.

The assessment will be based on the project report and satisfactory participation in the course in




general.

Marking scale

passed/not passed

Censorship form




Knowledge

• understand pharmacoepidemiological and pharmacovigilance methods used to generate

the evidence for benefit/risk assessments

• understand and explain central pharmacoepidemiological and pharmacovigilance

concepts.

• explain principles of safety surveillance and risk management, including the obligations of

the pharmaceutical industry and the basis for regulatory decisions.

• identify and summarise the limitations of pharmacoepidemiological studies and safety

surveillance systems.

Skills

• describe, analyse and interpret the results of pharmacoepidemiological studies and safety

surveillance.

• assess and discuss the limitations of data and methods in published literature and safety

reports.

• summarise and prioritise safety information obtained with different methods in a

structured way.

• communicate information on safety issues and drug-related risks.

Competences

• independently develop a protocol and plan for a post-authorisation safety study.

• perform a general benefit/risk assessment of a drug, integrating results from studies on

efficacy and safety, data from safety surveillance systems and other information.

• outline a risk management plan for a marketed drug based on information on safety issues

and patterns of use.

Workload

Category Hours

Lectures 40

Preparation 81

Theory exercises 10

Project work 70

Class Exercises 5

Total 206

Course information

Language

English

Course code

TEMP181901

Credit

7,5 ECTS

Level

Full Degree Master


Duration

1 block

Placement

Block 3

Schedule

C

Course capacity

60 students




Department of Drug Design and Pharmacology

Course Coordinators

Morten Andersen ([email protected])










Advarsel





TEMP1234RS Regulatory Science


Education





Content

Pharmaceuticals are one of the most regulated products in society. The policies and regulations

influencing the availability and use of pharmaceuticals are international, national and local.

Regulators and drug developer must make decisions from the earliest preclinical stages through

all phases of drug development.

The regulatory framework for medicines is constantly evolving. The system changes in order to

adapt to scientific developments; address medical needs; bring medicines to patients earlier (and

with better evidence); and also to keep prescribing information up to date. In Regulatory Science

we seek to study and evaluate the regulatory system as such in terms of impact on ensuring

patient safety, enhancing public health and stimulating the development of medicines.

The aim of the course is to give participants insight into and understanding of Regulatory Science

as well as giving the participants a better understanding of the theories and methods available

for analysing the effects of regulatory systems and interventions.

Learning Outcome

On completion of the course participants should be able to:

Knowledge

• Understand the current regulatory system of medicines

• Understand the political and legal framework of drug regulation

• Describe the traditional process of drug discovery and development, and relate this to the

current regulatory framework

• Describe various research approaches applied in regulatory science

• Describe use of strategies and existing data sources for to be used in Regulatory Science

research

Skills

• Identify and conceptualise relevant regulatory science research question and hypothesis,

through analysing the scientific literature in context of regulatory systems

• Identify and apply approaches and methods to address Regulatory Science research

questions

• Identify appropriate data sources, and methods for data extraction and validation, to study

a regulatory science research question.

Competences

• Discuss and critique Regulatory Science research and its implications

• Effectively communicate the value of Regulatory Science, including priorities and gaps to

stakeholders, including colleagues, policy makers, the media, and the public

Literature

Background literature on applicable theory and research methods

Scientific literature

Relevant Regulatory Guidelines

Formal requirements

Non.


A bachelor’s degree in health, natural or technical sciences.


Lectures and teaching in classes (50 hours in total).

Group case work including preparation of written reports and oral presentations as well as

smaller individual assignments (100 hours)

Preparation for classes, self-study (56 hours).

Feedback form




Sign up


This course is not available for credit transfer students and other external students.


Credit

7,5 ECTS

Type of assessment

Oral defence


Participate to a satisfactory level

Submit written work

Take part in group presentation of written work.

Present individual written review

Be able to discuss and critique own and others work

Aid

Written aids allowed

Marking scale

passed/not passed

Censorship form



To obtain a course certificate the student should be able to:

Knowledge

• Understand the current regulatory system of medicines

• Understand the political and legal framework of drug regulation

• Describe the traditional process of drug discovery and development, and relate this to the

current regulatory framework

• Describe various research approaches applied in regulatory science

• Describe use of strategies and existing data sources for to be used in Regulatory Science

research

Skills

• Identify and conceptualise relevant regulatory science research question and hypothesis,

through analysing the scientific literature in context of regulatory systems

• Identify and apply approaches and methods to address Regulatory Science research

questions

• Identify appropriate data sources, and methods for data extraction and validation, to study

a regulatory science research question.

Competences

• Discuss and critique Regulatory Science research and its implications

• Effectively communicate the value of Regulatory Science, including priorities and gaps to

stakeholders, including colleagues, policy makers, the media, and the public

Workload

Category Hours

Lectures 50

Course Preparation 56

Study Groups 100

Total 206

Course information

Language

English

Course code

TEMP1234RS

Credit

7,5 ECTS

Level

Full Degree Master


Duration

1 block

Placement

Block 4

Schedule

C

Course capacity

60

Study board




Course Coordinators

Christine Erikstrup Hallgreen ([email protected])

Lecturers

Christine Erikstrup Hallgreen (zkj621)

Marie Louise De Bruin

External lectures Saved on the 22-12-2017



Advarsel





SFKKB9091U In-vitro Techniques in Biochemistry and

Pharmacology


Education




MSc Programme in Pharmaceutical Sciences (English programme)- elective

MSc Programme in Environmental Science (SCIENCE) - restricted elective

Content

The following practical elements are included: primary cell cultures, neurotransmitter

transporters, receptor activation (GPRC and ligand-gated ion-channel receptors), receptor

binding, TEVC electrophysiology, voltage-clamp fluorometry (VCF), second messenger

measurements, FRET, smooth muscle contraction/relaxation, CytP450 and drug metabolism,

separation of lipophilic drug metabolites, use of radioisotopes, drug effects on isolated

mitochondria.

Learning Outcome

By the end of the course, the students will have acquired the competences to:

Knowledge

• demonstrate a firm knowledge of in vitro pharmacology

• understand common in vitro experimental methodologies as applied in pharmacology

• demonstrate a basic knowledge of pharmacodynamic theory

• demonstrate a basic understanding of radioisotope theory in scintillation counting

Skills

• The students will acquire practical and theoretical abilities and skills in pharmacological in

vitro research techniques that are applicable in both academic and biotech/pharmaceutical

drug discovery research environments. The specific aim is to acquire the abilities and

practical skills required to be able to work in a pre-clinical drug discovery research

environment and/or communicate proficiently with other professionals.

• prepare cultures of primary mouse neurons

• execute neurotransmitter uptake experiments employing cultured neurons

• measure cAMP (second-messenger) in cultured cells by FRET

• employ isolated mouse vas deferens to measure the effect of morphine-like pain-relieving

drugs

• employ two-electrode voltage clamp (TEVC) electrophysiology technique as a functional

assay of drugs affecting the operation of ion channels

• employ voltage clamp fluorometry (VCF) technique as a functional assay of drugs affecting

the operation of ion channels

• employ radioligand binding assays in drug investigations and interpret the resulting

pharmacologial data

• analyze cytochrome P450-mediated metabolism of a radiolabeled drug in a liver

homogenate employing thin layer chromatography (TLC) and subsequent scintillation

counting

• isolate crude mitochondria from a mouse liver homogenate

• employ isolated mitochondria to perform a simple in vitro screen of toxicity related to

mitochondrial function of unknown drugs.

Competences

• work with and/or communicate proficiently with other professionals within the field of in

vitro pharmacology

• design simple in vitro assays of drug activity including choosing the proper model system

and assay conditions

• calculate and interpret pharmacological data (dose-response relationships)

• apply knowledge of in vitro pharmacology to evaluate pharmacological data in relation to

the drug discovery process

Literature

• Lab manual (Pickering and Hansen)

• Receptor theory notes (Sheykhzade and Pickering)

• Radioisotope theory notes (Hansen and Pickering)


Students should have completed bachelor’s level lecture course(s) in biochemistry and/or

pharmacology as well as a lab course in chemistry and/or biochemistry.


Lab exercises: 40 hours

Tutorials: 21 hours

Remarks

The schedule for this course is not compatible with that of Clinical Pharmacy Practice

(SFKKB9011U).

This course also runs in week 42.

Attendance in all lab exercises and tutorials is mandatory.

Feedback form

Oral

Collective


Sign up







Credit transfer and other external students are welcomed on the course if there are seats

available and they have the academic qualifications.

Exam (SFKKB9091E - written examination)

Credit

7,5 ECTS

Type of assessment

Written examination, 2 hours under invigilation

Examination design

The course examination will consist of 20 short-answer questions covering the practical and

theoretical aspects of all the laboratory exercises. All written answers will be given an equal

weighting and then the course leaders will assess the overall examination performance level.

Students must have attended all the laboratory exercises and tutorials.

Aid

Without aids

There is access to the following at the exam on Peter Bangs Vej:

• Office (Word, Excel, Onenote and Powerpoint)



• Paint

• Calculator – Windows' own


• MathType formel programme

• Maple




• Adobe reader usb is not allowed

Marking scale


Censorship form




Knowledge

• demonstrate a firm knowledge of in vitro pharmacology

• understand common in vitro experimental methodologies as applied in pharmacology

• demonstrate a basic knowledge of pharmacodynamic theory

• demonstrate a basic understanding of radioisotope theory in scintillation counting

Skills

• prepare cultures of primary mouse neurons

• execute neurotransmitter uptake experiments employing cultured neurons

• measure cAMP (second-messenger) in cultured cells by FRET

• employ isolated mouse vas deferens to measure the effect of morphine-like pain-relieving

drugs

• employ two-electrode voltage clamp (TEVC) electrophysiology and voltage-clamp

fluorometry (VCF) techniques as a functional assay of drugs affecting the operation of ion

channels

• employ radioligand binding assays in drug investigations and interpret the resulting

pharmacologial data

• analyze cytochrome P450-mediated metabolism of a radiolabeled drug in a liver

homogenate employing thin layer chromatography (TLC) and subsequent scintillation

counting

• isolate crude mitochondria from a mouse liver homogenate

• employ isolated mitochondria to perform a simple in vitro screen of toxicity related to

mitochondrial function of unknown drugs.

Competences

• work with and/or communicate proficiently with other professionals within the field of in

vitro pharmacology

• design simple in vitro assays of drug activity including choosing the proper model system

and assay conditions

• calculate and interpret pharmacological data (dose-response relationships)

• apply knowledge of in vitro pharmacology to evaluate pharmacological data in relation to

the drug discovery process

Workload

Category Hours

Colloquia 21

Lectures 1

Preparation 80

Exam Preparation 64

Practical exercises 40

Total 206

Course information

Language

English

Course code

SFKKB9091U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 1

Schedule

C

Course capacity

56 students


Study board




Course Coordinators

Darryl S Pickering ([email protected])


Lecturers

Announced at the course start.


Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration


Advarsel





SFKKIF007U Advanced Manufacturing of

Pharmaceuticals

Expand allVolume 2018/2019

Education

MSc Programme in Food Science and Technology with specialization

in Process Analytical Technology (SCIENCE) - compulsory





Content

The course will introduce the critical tools needed for future professionals working in drug

development and manufacturing of pharmaceuticals. The main goal is to provide students with

knowledge required for designing robust medicinal product using Quality by Design (QbD)

principles. The course will start by introducing the unit operations used in manufacturing of

pharmaceuticals. This part covers primary manufacturing of both small molecules (synthesis and

crystallization) as well as biologics (fermentation and related separation technologies), followed

by introduction of secondary manufacturing steps (granulation, tableting and coating), as well as

spray/freeze drying technologies for biologics. Special focus will be on introducing enabling

manufacturing solutions for nanomedicine. Theory and practice will be introduced hand in hand

with lectures and excursions to local industry including examples from both small molecule and

biologics. Next phase involves the introduction of central Quality by Design tools - Design of

Experiments (DoE) and chemometrics, as well as physical modelling of system behavior. Students

will be introduced to different levels of modelling used in designing robust manufacturing

processes – starting from modelling molecular interactions explaining the behaviour of systems

with pharmaceutical interest, and proceeding to modelling of process performance based on

engineering principles. Specific examples of process analytical technologies (PAT) will be

discussed with a special focus on analytical tools applicable for the analysis of moving matter.

The last part of the course provides deeper insight into the general structure of pharmaceutical

quality systems and risk management approaches. Principles of the plant design of

pharmaceutical manufacturing sites will be introduced. For project work, students will work in

small groups of 4 students around given formulation/processing example. Project work will be

presented during project presentation.

Learning Outcome

To provide students with fundamental knowledge related to manufacturing of pharmaceuticals.

Participants will gain deeper insight into all critical unit operations of pharmaceutical interest, as

well as an introduction to functions of pharmaceutical quality systems and plant design

principles. All this will be introduced as a sound combination of lectures and excursions to local

industry. The Quality by Design (QbD) approach will be a key element in the course. Design of

Experiments (DoE) and chemometrics, as well as physical modelling will be explained through

lectures and practical exercises. After finishing the course, students should also be able to use

the physicochemical principles to analyse the processability of a given dosage form.


Knowledge

• analyse the critical unit operations used in manufacturing of small molecule and biologics

based medicinal products

• understand the importance of formulation design in relation to manufacturing according to

Quality by Design (QbD) principles

• demonstrate insight into pharmaceutical quality systems, risk management techniques and

plant design of pharmaceutical manufacturing sites

Skills

• perform Design of Experiments (DoE) and multivariate data analysis

• construct risk assessment of a given pharmaceutical product

• apply the general principles of physical modelling related to manufacturing of

pharmaceuticals.

Literature

Lecture notes and relevant publications are available from the course homepage.

Formal requirements

Non.


Students are expected to have a good knowledge of formulation and processing of dosage forms,

as well as an interest in becoming a future specialist in the field of pharmaceutical development.


Theory and practice will be introduced hand in hand with lectures and excursions to local

industry including examples from both small molecule and biologics. For project work, students

will work in small groups of 4 students around given formulation/processing example. Project

work will be presented during project presentation.

•Lectures: 32 hours

•Demonstration: 4 hours

•Excursions: 12 hours

•Seminar: 4 hours

Sign up









Exam (SFKKIF007U - continuous assessment)

Credit

7,5 ECTS

Type of assessment


Course certificate:

The student will achieve a course certificate when participation satisfactory during the lectures,

exercises, project work and project presentation.

Marking scale

passed/not passed

Censorship form



Satisfactory participation during the lectures, exercises, project work and project presentation.

To pass the course the student must be able to:

Knowledge

• analyse the critical unit operations used in manufacturing of small molecule and biologics

based medicinal products

• understand the importance of formulation design in relation to manufacturing according to

Quality by Design (QbD) principles

• demonstrate insight into pharmaceutical quality systems, risk management techniques and

plant design of pharmaceutical manufacturing sites

Skills

• perform Design of Experiments (DoE) and multivariate data analysis

• construct risk assessment of a given pharmaceutical product

• apply the general principles of physical modelling related to manufacturing of

pharmaceuticals.

Workload



Category Hours

Lectures 32

Project work 76


Excursions 12

Colloquia 4

Preparation 78

Total 206

Course information

Language

English

Course code

SFKKIF007U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 2

Schedule

B

Course capacity

60 students


Study board




Course Coordinators

Jukka Rantanen ([email protected])





Advarsel





SLKKIL110U Advances in Medicinal Chemistry

Research


Education

MSc Programme in Pharmaceutical Sciences (English programme) track I - compulsory




Content

The course will be based on 3-4 major themes covering the objectives of the course. Hence, all

subjects will be introduced in a theme driven interdisciplinary fashion. The themes will be

illustrated by original scientific reports and may cover:

• Target classes: receptors, transporters, enzymes, regulatory proteins

• Target-ligand interactions

• Structure – activity relationship (SAR) studies

• Structure and ligand based drug design

• Point of action and the prodrug concept

• Peptidomimetics and protein based drugs

• Drugability of lead compounds

• Experimental methods in biological and biostructural chemistry

• Basic and advanced medicinal chemistry concepts

• 3D modeling of protein structure and ligand docking

As the course aims to highlight recent cutting edge research in medicinal/biostructural chemistry,

themes vary but may cover: hypnotics, psychotropic drugs, immunomodulating agents, antiviral

agents, neurotransmitters, chemotherapeutics, antineoplastics, drugs against neurodegenerative

diseases and schizophrenia. During the course the students will cover three themes in groups of

4-5 persons. for each theme the groups will carry out literature search, write up a report and

prepare a poster for oral presentation.

Learning Outcome

The original literature plays a pivotal role in the discovery of new drugs. In order to contribute to

the process it is necessary to comprehend and to be able to communicate the content of primary

research papers to others. The literature is the primary source of information in all steps of the

drug discovery process including:

• Biology of targets

• Identification of interfering agents (drug candidates).

• Optimization of interfering agents.

Importantly, the course aims at providing knowledge about the above-mentioned individual

steps, while ensuring that the students do not consider each process isolated from the others.

Hence, the students will have a collected understanding of biostructural/medicinal chemical

aspects. Earlier courses provide in-depth insight to isolated techniques/theory. Rather, at this

later time-point in the student’s education, an integrated view is acquired.

Drugs interfere with complex biological systems. In order to design targeted and specific drugs it

is necessary to understand the system they interact with. Researchers will need to be able to

quickly understand new techniques for the identification and optimization of biologics and small

molecule compounds. The course objective is to train the students in acquiring the above-

mentioned skills. They will work with original literature concerning particular indications. The

indications may vary, and can include: cancer, diseases of the central nervous system, viral

infections, neurodegenerative diseases, amyloid diseases.

At the end of the course, students will be able to:

Knowledge

• understand that particular cellular processes at the molecular level may lead to disease

• understand the content of original literature describing complex biological systems of

relevance in drug research

• understand how the 3-dimensional structure of biological macromolecules plays a role for

understanding the molecular basis of particular diseases, and for intervening with the

disease progress

• understand the content of original literature describing the identification and optimization

of small molecule compounds that can interfere with complex biological systems

• understand the content of original literature describing the impact of interfering with

protein-protein interactions using designed biological macromolecules (biologics)

• understand how medicinal chemistry is an interdisciplinary field, building on basic scientific

understanding of molecular and biological processes, exploiting detailed structural

information and applying advanced chemistry for purposeful intervention

Skills

• choose experimental techniques and methods for use in the different stages in medicinal

chemistry research

• compare and assess results obtained using different techniques and methods in medicinal

chemistry research

• critically assess potentially conflicting reports in original literature

• select essential literature for a specific topic

• compare and assess the quality of 3D structural knowledge based on either experimental

data or homology models

Competences

• collaborate and coordinate projects together with other professionals with expertise in

medicinal chemistry related areas

• extract relevant and detailed information concerning a particular drug target from 3-D

structural data files

• disseminate knowledge from the literature in a comparative and critical fashion

• translate relevant information from the basic understanding of the cellular biology behind

diseases, via a molecular understanding of the relevant targets, to the relevance of

chemical optimization of lead molecules for intervention.

Literature

Reviews and original scientific papers available at the course website.

Formal requirements

Non.


The teaching is arranged with the assumption that students have knowledge from basic courses

in organic chemistry, physical chemistry, biochemistry, general pharmacology and medicinal

chemistry.


•Lectures: 9

•Class lessons: 17

Feedback form

Written

Oral

Individual

Collective

Sign up









Exam (SLKKIL110E - oral examination)

Credit

7,5 ECTS

Type of assessment

Oral examination, 25 min

The oral examination consists of a 20 min. student presentation and questioning by examiner

followed by 5 min. evaluation. The exam is without preparation time.

Examination is based on a poster presentation, submitted by the student.

Aid

Without aids

Marking scale

passed/not passed

Censorship form



To achieve the grade Passed, the student must adequately be able to:

Knowledge

• understand that particular cellular processes at the molecular level may lead to disease

• understand the content of original literature describing complex biological systems of

relevance in drug research

• understand how the 3-dimensional structure of biological macromolecules plays a role for

understanding the molecular basis of particular diseases, and for intervening with the

disease progress

• understand the content of original literature describing the identification and optimization

of small molecule compounds that can interfere with complex biological systems

• understand the content of original literature describing the impact of interfering with

protein-protein interactions using designed biological macromolecules (biologics)

• understand how medicinal chemistry is an interdisciplinary field, building on basic scientific

understanding of molecular and biological processes, exploiting detailed structural

information and applying advanced chemistry for purposeful intervention

Skills

• submit three written reports to a satisfactory level

• participate in oral presentations of the subjects, that are based on poster presentations.

• choose experimental techniques and methods for use in the different stages in medicinal

chemistry research



• compare and assess results obtained using different techniques and methods in medicinal

chemistry research

• critically assess potentially conflicting reports in original literature

• select essential literature for a specific topic

• compare and assess the quality of 3D structural knowledge based on either experimental

data or homology models

Competences

• collaborate and coordinate projects together with other professionals with expertise in

medicinal chemistry related areas

• extract relevant and detailed information concerning a particular drug target from 3-D

structural data files

• disseminate knowledge from the literature in a comparative and critical fashion

• translate relevant information from the basic understanding of the cellular biology behind

diseases, via a molecular understanding of the relevant targets, to the relevance of

chemical optimization of lead molecules for intervention.

Workload

Category Hours

Lectures 26

Project work 88

Preparation 91,5

Exam 0,5

Total 206,0

Course information

Language

English

Course code

SLKKIL110U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 4

Schedule

A

Course capacity

30 students (20 seats reserved to students at the MSc Programme in Pharmaceutical Sciences).





Course Coordinators

Bente Frølund ([email protected])

Study secretary: Jeanette Bangsbøll Dunn ([email protected])










Advarsel





SFKKIF002U Biopharmaceuticals: Protein Production and

Analysis - Is scheduled for autumn 2019


Education





Content

This course aims to provide students with the required practical laboratory competencies for

preparatory and analytical research with proteins during pharmaceutical development. During

the course the students will gain competency with the key in-vitro techniques for working with

proteins in a laboratory. Specifically, the course covers recombinant protein expression, protein

purification and analysis of proteins and in particularly how these aspects are closely

interconnected for quality control/analysis of protein biopharmaceuticals in the phamacopoiea.

Topics will be dealt with from a practical perspective relevant to both academic and

biotech/pharmaceutical drug discovery/development environments.

The most relevant course topics are:

• Physicochemical properties of peptides and proteins and challenges to in-vitro handling

and laboratory work with proteins (protein stability, pH, temperature, concentration,

aggregation, unfolding)

• Introduction to protein sequence databases (Uniprot, Protein Data Bank)

• Recombinant protein expression in host cells (E.coli, yeast, mammalian cells)

• Principles of protein separation and chromatographic purification (affinity, ion-exchange,

size-exclusion, HIC, HPLC)

• Basic methods for analysis of primary protein structure (SDS-PAGE, intact mass analysis by

mass spectrometry (MS))

• Advanced methods for analysis of primary structure and covalent modifications (amino

acid analysis, LC-MS, IEF, peptide mapping analysis by enzymatic digestion and MS)

• Methods for analysis of the higher-order structure of protein biopharmaceuticals during

development (fluorescence, CD, NMR, SEC, DLS, HDX-MS etc.)

• Quality control of protein biopharmaceuticals in the pharmacopoiea

• Methods for quantitation of proteins in pure samples (spectroscopy, biochemical assays)

and in complex biological samples (host cell protein analysis, pharmacokinetics, drug

metabolism

This course is centered around a practical component that involves a series of open structured

laboratory sessions where students in groups are provided an unknown protein sample and

access to lab stations with equipment for purifying and analyzing proteins. The laboratory work

in this course should therefore be viewed as a mini-research project rather than a predefined

series of laboratory exercises. By applying theory learned during the lectures, the students will

plan their experimental work in an independent manner and subsequently carryout the

purifcation and analysis/quality control of a protein of interest in the unknown sample.

As part of this laboratory-based course, the students will write a group report that describes a

detailed description and interpretation of results obtained during their laboratory project.

Furthermore, each student must prepare an appendix to the group report on a individually

chosen study topic of interest in preparatory or analytical biopharmaceutical science.

Finally, students of the course will get the opportunity to participate in a one-day excursion to

Novo Nordisk A/S where two in-house scientists will give lectures on how protein production and

analysis is performed at a large biopharmaceutical company like Novo Nordisk. This excursion

will also include a tour of facilities at Novo Nordisk for large scale protein expression and

purification.

Learning Outcome

The objective of this course is to provide the students with the knowledge and practical

competencies neccesary for experimental work with proteins in a laboratory setting. The specific

aim is for students to acquire abilities and skills with the handling, purification and analysis of

proteins and/or be able to communicate proficiently with researchers in a biotech drug

discovery/development environment.


Knowledge

• describe the primary structure, covalent modifications and higher-order structure of

proteins and how these determine protein function.

• understand the basic chemical and physical properties of proteins in solution (charge,

solubility, hydrophobicity, affinity).

• explain the principles of recombinant protein expression and the strengths/weaknesses of

different host cell systems.

• describe the common methods for protein purification and their underlying physical

principles for protein separation

• understand the common methods for analysis of protein primary structure and common

covalent modifications of proteins

• understand the common methods for analysis of higher order protein structure and

physical size/oligomerization.

• understand methods for quality control of protein biopharmaceuticals in the

pharmacopoiea.

• search bioinformatics databases for the aminoacid sequence, molecular mass and

chemical properties of a target protein

• search bioinformatics databases for structural information for a target protein and visaluze

higher-order protein structure using molecular graphics software.

Skills

• identify the strengths and weaknesses of different analytical methods to analyze the

primary or higher-order structure of protein biopharmaceuticals during development.

• perform affinity chromatography to purify a protein from crude cell extract

• perform size-exclusion chromatography for fine-grade purification of a protein from other

protein components

• determine the concentration of protein in a sample by UV absorbance spectroscopy

• perform enzymatic digestion and MALDI mass spectrometry to identify and localize stress-

induced covalent modifications to the primary structure of a purified protein

Competences

• discuss and critically evaluate the use of protein purification and protein analysis in the

scientific literature and during biopharmaceutical development.

• apply gel electrophoresis (SDS-PAGE) to identify protein components in a complex mixture

• employ analytical HPLC to determine protein purity and purification yield

• prepare and execute ESI and MALDI mass spectrometry to determine the molecular mass

and quality control of a purified protein

• apply fluorescence spectroscopy to assess the higher-order structure of a protein

Literature

• Lecture notes and research/review papers on purification and analysis of proteins available

on the course homepage

• Laboratory protocols and course appendix

• Chapters from the book: "Protein Analysis and Purification - Benchtop techniques". 2nd

edition, Ian M. Rosenberg. Birkhauser. 2005.

• Chapters from the book: "Methods for Structural Analysis of Protein Pharmaceuticals".

Edited by Wim Joskoot and Dan Crommelin. AAPS, 2005.


The main academic prerequisites are a basic understanding of protein structure, bioorganic

chemistry, microbiology, thermodynamics (physical chemistry), and analytical chemistry.


• Lectures: 20 hrs

• Laboratory: 56 hrs

• Project work (individual study report): 20 hrs

Sign up









Exam (SFKKIF002E - written examination)

Credit

7,5 ECTS

Type of assessment

Written examination, 1 hour under invigilation

Multiple Choice

The multiple choice-test is made up of a number (typically 25) of statements to which the student

has to decide whether they are true or false.

Exam registration requirements

• Participation in all laboratory exercises.

• In order to be able to take the exam, the laboratory group report and oral presentation of

the group report must be approved.

• In order to be able to take the exam, the student‘s report and oral presentation of the

"Independent Study Report" must be approved.

Aid

Without aids





• Paint



• MathType - formel programme

• Maple


• Adobe reader usb-stick is not allowed

Marking scale

passed/not passed

Censorship form




Knowledge

• describe the primary structure, covalent modifications and higher-order structure of

proteins and how these determine protein function.

• understand the basic chemical and physical properties of proteins in solution (charge,

solubility, hydrophobicity, affinity).



• explain the principles of recombinant protein expression and the strengths/weaknesses of

different host cell systems.

• describe the common methods for protein purification and their underlying physical

principles for protein separation

• understand the common methods for analysis of protein primary structure and common

covalent modifications of proteins

• understand the common methods for analysis of higher order protein structure and

physical size/oligomerization.

• understand methods for quality control of protein biopharmaceuticals in the

pharmacopoiea.

• search bioinformatics databases for the aminoacid sequence, molecular mass and

chemical properties of a target protein

• search bioinformatics databases for structural information for a target protein and visaluze

higher-order protein structure using molecular graphics software.

Skills

• identify the strengths and weaknesses of different analytical methods to analyze the

primary or higher-order structure of protein biopharmaceuticals during development.

• perform affinity chromatography to purify a protein from crude cell extract

• perform size-exclusion chromatography for fine-grade purification of a protein from other

protein components

• determine the concentration of protein in a sample by UV absorbance spectroscopy

• perform enzymatic digestion and MALDI mass spectrometry to identify and localize stress-

induced covalent modifications to the primary structure of a purified protein

Competences

• discuss and critically evaluate the use of protein purification and protein analysis in the

scientific literature and during biopharmaceutical development.

• apply gel electrophoresis (SDS-PAGE) to identify protein components in a complex mixture

• employ analytical HPLC to determine protein purity and purification yield

• prepare and execute ESI and MALDI mass spectrometry to determine the molecular mass

and quality control of a purified protein

• apply fluorescence spectroscopy to assess the higher-order structure of a protein

Students requiring a grade for the exam, should contact the course responsible.

Workload

Category Hours

Lectures 20

Preparation 40


Preparation 24

Exam 2

Preparation 64

Total 206

Course information

Language

English

Course code

SFKKIF002U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 2

The course is scheduled for fall 2019. The course will not run during 2018.

Schedule

A

Course capacity

32 students





Course Coordinators

Kasper Dyrberg Rand ([email protected])

Lecturers

Kasper D. Rand

Marco van de Weert

Osman Mirza









Advarsel





SFKKIL007U Biopharmaceuticals: Design and

Modification of Biomacromolecules


Education

MSc Programme in Medicinal Chemistry - compulsory




Content

Besides an introduction to the concepts and methods that are relevant for investigating and

understanding the physicochemical and pharmacological properties of macromolecules the

course focus on the design, discovery and applicability of biopharmaceutical drugs, primarily

those based on peptides or proteins.

Furthermore, this course will form the basis for studies on optimization of pharmaceutical

properties of peptides, proteins and nucleic acids in relation to preclinial and clinical drug

development. Finally, drug leads derived from these classes of macromolecules (e.g.

peptidomimetics, oligonucleotide analogues and oligosaccharides) as well as relevant delivery

vehicles will be discussed.

These subjects will be introduced via lectures (based on book chapters and comprehensive

reviews and articles), while the class sessions will comprise student presentations and discussion

of selected scientific articles in order to facilitate an in-depth understanding of both theoretical

and practical aspects of biopharmaceutical drug research. In addition, some class sessions will

comprise theoretical execises on the basic elements of the course (e.g. peptide synthesis

and protein modification). Also, the course comprises three practical exercises in a chemical

synthesis lab. These exercises illustrates basic solid-phase peptide synthesis methodology and

protein modification. For each excercise a laboratory notebook should be kept in order to

facilitate writing of mandatory reports which also comprise answering specific questions and

interpretation of analytical results (LC-MS, MALDI and ELISA).

The most relevant compound classes and their applications are briefly outlined below:

• Peptide- and protein-based drugs, inculding modified peptide and proteins (primary

content of the course).

• Introduction to antibodies and therapeutic relevance.

• Oligonucleotides for gene therapy and antisense siRNA as putative biopharmaceutical

drugs.

Methods and concepts:

• Importance of structure for pharmacological activity and suitable drug properties: charge,

solubility, stability and delivery.

• Primary sequence and folding into secondary and tertiary structures and methods for

manipulating these.

• Principles of solid-phase peptide synthesis (incl. combinatorial and parallel approaches)

and optimization. Advanced peptide chemistry including selection of linkers, coupling

reagents and protecting groups.

• Protein biosynthesis and modification: post-translational and chemical transformations.

• Genetic and protein engineering as a discovery and production tool for biological protein

and peptide expression and modification.

• Practical manual solid-phase peptide synthesis and simple modification of proteins.

• Chemical protein synthesis and semisynthesis

Learning Outcome

The purpose of this course is to provide students with theoretical knowledge on

biopharmaceutical drug discovery as a central part of contemporary and future interdisciplinary

drug discovery efforts in academia as well as in the biotech and pharmaceutical industry.

The focus will primarily be on peptides and proteins as they currently constitute the most

important class of biopharmaceuticals.

An additional aim is to introduce students to methodologies related to chemical synthesis,

biological expression, and modification of biopharmaceuticals with a focus on their applications

in drug discovery and development.


Knowledge

• comprehend the steps involved in biopharmaceutical drug discovery

• understand aspects of chemical peptide synthesis relevant for biopharmaceutical drug

discovery

• understand post-translational peptide/protein modifications

• understand methods used in chemical peptide and protein modification

• understand the concept of unnatural amino acid mutagenesis

• appreciate of the potential of novel types of biopharmaceuticals (e.g. nucleic acids and

analogs thereof) in sufficient detail to follow future scientific developments

Skills

• assess the implications of peptide/protein sequence on their folding into

secondary/tertiary structure

• search and read relevant literature and use this knowledge in biopharmaceutical research

projects.

• perform simple solid-phase peptide synthesis and protein modification

Competences

• read and discuss research examples concerning optimization of biologically active peptide

drug leads with respect to pharmacological properties including bioavailability and in vitro

cytotoxicity

• apply basic theory of peptide optimization and protein engineering/expression related to

practical development of biopharmaceuticals

Literature

Peptide Synthesis and Applications, K. J. Jensen, A. P. Tofteng, S. L. Pedersen (Eds), Springer

Protocols, Humana Press, 2013.

Selected book chapters:

Textbook of Drug Design and Discovery (CRC Press; eds. P. Krogsgaard-Larsen K. Strømgaard, U.

Madsen)

Pharmaceutical Formulation Development of Peptides and Proteins (CRC Press 2012; eds. L.

Hovgaard, S. Frøkjær, M. van de Weert)

Peptide and protein derivatives (p. 131-148), in Pharmaceutical Formulation Development of

Peptides and Proteins (Taylor & Francis 2012; eds. M. van de Weert, S. Frøkjær & L. Hovgaard)

Supplementary reviews and research papers covering the following topics:

Examples of subclasses of potential drug leads (peptides, peptidomimetics and proteins), known

biopharmaceuticals (e.g. peptide hormones, cytokines, antibodies, nucleic acids and analogues

thereof, as well as adjuvants/vaccines and drug delivery vehicles.

All teaching materials besides the textbook comprise parts of textbooks already used in other

courses concerning biopharmaceuticals, or it will be available via the course homepage or as

handout material.


Basic knowledge in organic and bioorganic chemistry and molecular biology is a prerequisite.


Lectures: 21

Class sessions: 12

Writing of individual study report (ca. 40 hours during last 3 weeks)

Practical exercises (15 hours in lab)

Feedback form

Written

Individual

Upon grading of the essay (written assignment) the students will receive a performance scheme

(uploaded together with the grade in digital exam) stating which parts/features of the essay that

were: (i) very good, (ii) could be improved, (iii) was only just acceptable, or (iv) inacceptable.

Sign up









Exam 1 (Lab exercises (continuous assessment))

Credit

0 ECTS

Type of assessment


Course certificate: The students work in groups of 3-4 persons preparing a joint lab journal and

report on the performed experiments including answering of the associated questions.

Aid

All aids allowed

The lab teachers may be approached for guidance in answering the associated questions.

Marking scale

passed/not passed

Censorship form


Re-exam

Possibility for improving "not-approved" to "approved" before the MC exam takes place.

If "not-approved" not to a sufficient degree has been attempted improved to "approved" within

the associated examination period the experimental part of the course must be repeated.



Knowledge:

• show that the basic concepts have been understood through answering the associated

questions.

• show that the basic concepts have been understood.

• a theoretical background to understand synthesis descriptions of simple chemical

reactions involving peptides relevant as biopharmaceuticals.

Skills:

• carry out the laboratory work to satisfaction.

• perform experiments with acceptable results and described in a scientific way, so that the

synthesis and analysis excercises may be repeated.



• performing simple syntheses and analysis of peptides.

Competences:

• write a report in a scientific language how exsperimental work has been performed.

Exam 2 (SFKKIL007E - written assignment)

Credit

5 ECTS

Type of assessment

Written assignment

Individual written assignment (essay) in the format of a scientific minireview (size: min 15.000 and

max. 25.000 characters including spaces; supporting figures allowed) based on literature studies

on a subject agreed upon with one of the teachers and approved with the course directors. The

essay must relate to a substantial content of chemistry as well as a biology/biopharmaceutical

aspect. The student will have 3 weeks to prepare this.

Aid

All aids allowed

Marking scale


Censorship form




Knowledge

• comprehend the steps involved in biopharmaceutical drug discovery

• understand of aspects of chemical peptide synthesis relevant for biopharmaceutical drug

discovery

• understand of post-translational peptide/protein modifications

• understand of methods used in chemical protein modification

• understand of the concept of unnatural mutagenesis

• appreciate the potential of novel types of biopharmaceuticals comprising nucleic acids (and

analogs thereof) and oligosaccharides in sufficient detail to follow future scientific

developments in these fields

Skills

• assess the implications of peptide/protein sequence on their folding into

secondary/tertiary structure

• device chemical synthesis of relevant peptides and modification of protein drugs

• search and read relevant literature and use this knowledge in biopharmaceutical research

projects.

• discuss and illustrate how a specific type of biopharmaceuticals may be discovered via

synthesis/expression of leads that undergo optimization using appropriate methodologies.

Competences

• read and discuss research examples concerning optimization of biologically active peptide

drug leads with respect to pharmacological properties including bioavailability and in vitro

cytotoxicity

• apply basic theory of peptide optimization and protein engineering/expression related to

practical development of biopharmaceuticals

Exam 3 (SFKKIL107E - written examination)

Credit

2,5 ECTS

Type of assessment

Written examination, 1 hour under invigilation

Multiple-choice test with 25-35 statements.

Aid

Without aids

There is access to the following at the exam:




• Paint




• Maple


• Adobe reader UBS-stick is not allowed.

Marking scale


Censorship form




Knowledge

• comprehend the steps involved in chemical peptide synthesis

• understanding properties and utility of specific commonly used reagents, building blocks

and protecting groups involved in chemical peptide synthesis

• understand post-translational peptide/protein modifications including reagents and

methods

• understand methods and specific common reagents used in chemical protein modification

• understand the concept and specific methods involved in unnatural mutagenesis

• understand basic concepts related to peptide optimization

• understand basic properties of peptidomimetics and biologically active peptides (e.g. AMPs

and CPPs)

• comprehend basic concepts, methods and properties related to nucleic acids (and analogs

thereof), antibodies, and vaccines

Skills

• assess utility and application of specific common reagents and methods related

to chemical peptide synthesis

• assess utility and application of specific common reagents and methods related

to modification of proteins

• assess concepts and specific methods involved in peptide optimization

• assess the properties of peptidomimetics and specific types of biologically active peptides

(e.g. AMPs and CPPs)

• assess basic concepts, methods and properties related to nucleic acids (and analogs

thereof), antibodies, and vaccines

Competences

• understand examples concerning biologically active peptide/protein drug leads with

respect to chemical synthesis/modification and optimization

• apply basic theory of peptide synthesis and optimization and protein engineering/

expression related to practical development of biopharmaceuticals

Workload

Category Hours

Lectures 21

Colloquia 8

Project work 40

Preparation 93

Exam 25

Laboratory 15

Theory exercises 4

Total 206

Course information

Language

English

Course code

SFKKIL007U

Credit

See exam description

Level

Full Degree Master

Duration

1 block

Placement

Block 1

Schedule

C

Course capacity

30 students (25 seats reserved students of MSc Programme in Medicinal Chemistry).





Course Coordinators

Kristian Strømgaard ([email protected])

Christian Adam Olsen ([email protected])

Lecturers

Kristian Strømgaard

Christian A. Olsen










Advarsel





SFKKIF008U Biopharmaceuticals: Formulation of

Peptides and Proteins


Education





Content

The programme module deals with pharmaceutical issues concerning the formulation of drugs

based on peptides and proteins. Students will also gain insight into analytical and production

problems as well as the regulatory aspects of registering biotechnological drugs.

The following topics will be dealt with:

A general introduction to the production methods used to produce peptides by synthesis.

Methods for optimizing the chemical and physical stability of peptides and proteins, including an

introduction to the analytical methods used for chemical and physical-chemical characterization

of these types of drugs.

There will be emphasis on formulation of solutions and freeze-dried preparations, and the

pharmaceutical formulation aspects of developing vaccines and alternative administration

methods are also included. Unwanted immunogenicity and pharmacokinetics of protein drugs

will be discussed.

The development of peptide and protein analogues will be covered.

There will be general description of the documentation necessary for the pharmaceutical-

chemical part of a registration application, with focus on the special conditions relevant to

biotechnological products.

For project work, students in groups of four to five will draft a development plan for a protein

drug from production of the drug (the protein) to registration, with the main focus on (pre-)

formulation work. Thus, the project work will include all of the aspects discussed during the

course, and must form the subject of a written report to be presented orally.

Learning Outcome

With focus on (pre-)formulation, the course describes the development of peptide- and protein-

based drugs from production.

At the end of the course, students are expected to:

Knowledge

• explain and discuss the principles of formulation for peptides and proteins

• explain and identify important degradation pathways of peptides and proteins

• explain and identify the most important methods for characterizing drugs based on

peptides and proteins

Skills

• outline the options for the formulation of peptides and proteins

• discuss and elaborate on the scientific literature in the field of peptide/protein formulation

Competencies

• make a development plan for a peptide or protein formulation

Literature

• Pharmaceutical formulation development of peptides and proteins, 2nd ed. S. Frokjaer, L.

Hovgaard, and Marco van de Weert, 2012, Taylor & Francis

• Selected articles and hand-outs available on the course homepage


The main academic prerequisites are a basic understanding of protein structure, organic

chemistry, microbiology, thermodynamics (physical chemistry), and analytical chemistry.


Lectures: 34 hours

Project work: 34 hours

Seminars: 8 hours

Feedback form

Oral

Collective


Sign up






Other external students: http://healthsciences.ku.dk/education/exchange_guest_students/guest-

students/




Credit

7,5 ECTS

Type of assessment

Course participation under invigilation

Written assignment

Course certificate:

Report and presentation of project work. Students are expected to actively participate in the

learning process, that is, in the lectures and in group work (literature searches, discussions within

the group, writing, presenting and defending the report). The students must also participate in a

minimum of 26 hrs of lectures and in all group presentations.

An attendance scheme will log sufficient attendance. Active participation requires a signed

declaration in the report of all group members that all group members actively participated. The

report must follow the guidelines layed out in the description of the group work. All group

members must act as opponents to one other group.

Students with insufficient attendance or insufficient contribution in the group work may be given

extra assignments, such as written evaluation of the report of other groups or short summaries

of lecture notes and/or book chapters on specific topics.

Marking scale

passed/not passed

Censorship form




Knowledge

• explain and discuss the principles of formulation for peptides and proteins

• explain and identify important degradation pathways of peptides and proteins

• explain and identify the most important methods for characterizing drugs based on

peptides and proteins

Skills

• outline the options for the formulation of peptides and proteins

• discuss and elaborate on the scientific literature in the field of peptide/protein formulation

Competencies

• make a development plan for a peptide or protein formulation

Workload

Category Hours

Lectures 34



Project work 34

Seminar 8

Preparation 130

Total 206

Course information

Language

English

Course code

SFKKIF008U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 1

Schedule

B

Course capacity

60 students


Study board




Course Coordinators

Marco van de Weert ([email protected])


Lecturers

Marco van de Weert, Lene Jørgensen, Hanne Mørck Nielsen, Camilla Foged, Kasper Dyrberg Rand,

Vito Foderà, and various industrial lecturers




Advarsel





SFKKM9011U Computational Medicinal Chemistry


Education

MSc Programme in Medicinal Chemistry - compulsory




Content

The course focuses on molecular modelling techniques and their use in modern drug research,

illustrated through lectures, exercises, and project work. In the lectures, the students are

introduced to the fundamental principles behind the methods in molecular modeling. In the

exercises, the students get hands-on experience with modern computer-based tools, and the

project work gives the opportunity to apply these tools on a drug targets with the aim of

understanding and improving the binding to a protein target.

The methods covered in the lectures, exercises, and project work are:

• investigating bioactive conformations of drug-like molecules

• analyzing molecular characteristics of ligands and protein binding sites

• structure-based drug design and ligand-based drug design

• pharmacophore development and quantitative structure activity relationships (QSAR)

• homology modelling

• docking of ligands into the binding pocket of the target protein.

• investigating protein-protein interfaces relevant for biopharmaceutics

Objective

The course is relevant for research within the drug discovery area and other areas where it is

important to:

• have knowledge about experimental and theoretical methods that can be used to analyze

molecular characteristics of biologically important molecules

• understand the interactions between ligands and biomacromolecules

• get hands-on experience with modern tools in molecular modeling to achieve skills to

develop new compounds

Learning Outcome

At the end of the course, students will be able to:

Knowledge

• explain the characteristics that influence the relationship between molecular structure and

biological activity

• be critical to the principles and methods used for rational discovery and development of

new or better drugs

Skills

• use and critically evaluate results achieved from structure determination of proteins and

drug-related compounds

• use and critically evaluate results obtained with modern computer-based methods for

structure-activity analysis of biologically active compounds

• have hands-on experience with modern tools in molecular modeling.

Competences

• plan a computer-based project on how to improve binding to a target

• apply the computer-based tools for projects in drug discovery

• select the appropriate molecular modelling techniques in modern drug research

Literature

• Reviews and scientific papers available at the course website

• Supplementary notes (notes with additional information on methods used – to be

downloaded from course homepage)

Formal requirements

non.


Teaching is organized on the assumption that students have already acquired knowledge in

medicinal and biostructural chemistry, including protein structures, biophysical techniques,

protein-ligand interactions, and basic organic and physical chemistry. No special skills for

computer programming are needed. Software with graphic user interfaces will be used.


•Lectures: 19 hours

•Computer exercises: 19 hours

•Project work: 77 hours

•Supervision during project work: guidelines will be available on the course homepage

•Exam: 0,5 hours

Feedback form

Oral



Computer exercises: There will be feedback after each computer exercise both from teacher and

as a digital quiz.

Lectures: Digital quizzes are used as a supplement to the lectures.

Project work: Initially, a project plan is discussed with the teachers, and during the project period

there will be progress discussions. In addition, the students will present and discuss the status of

the project for teachers and the other participants in the course.

Sign up









Exam (SFKKM9011E - oral examination)

Credit

7,5 ECTS

Type of assessment

Oral examination, 30 min

Individual 30 minutes oral exam (assessment included) with a presentation of project work

(based on the poster) as starting point for the exam, followed by an examination in the methods

presented and used during the course, i.e. all the written course material. The student is

expected to present:

- detailed knowledge of specified topics in the course material,

- basic knowledge of the rest of the course material, and

- detailed knowledge of own project

Aid

All aids allowed

Marking scale


Censorship form




Knowledge



• explain the characteristics that influence the relationship between molecular structure and

biological activity

• be critical to the principles and methods used for rational discovery and development of

new or better drugs

Skills

• be able to use and critically evaluate results achieved from structure determination of

proteins and drug-related compounds

• be able to use and critically evaluate results obtained with modern computer-based

methods for structure-activity analysis of biologically active compounds

• have hands-on experience with modern tools in molecular modeling.

Competences

• plan a computer-based project on how to improve binding to a target

• apply the computer-based tools for projects in drug discovery

• select the appropriate molecular modelling techniques in modern drug research

Workload

Category Hours

Lectures 19

Theory exercises 19

Preparation 70

Project work 77

Exam 21

Total 206

Course information

Language

English

Course code

SFKKM9011U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 4

Schedule

C

Course capacity

54 students ( 25 seats reserved students at the MSc Programme in Medicinal Chemistry).





Course Coordinators

Karla Andrea Frydenvang ([email protected])

Study secretary: Jeanette Bangsbøll Dunn ([email protected])










Advarsel





SFKKIF105U Entrepreneurship in Pharmaceuticals


Education





Content

This course is designed for students who want to learn about idea development, entrepreneurship,

and start-up processes within the pharmaceuticals (and related (bio) technologies) area. While

intellectual property rights form an important part of the content, the scope of the course is

broader than this, emphasizing an overview of entrepreneurship within the area, in which

intellectual property constitutes one of a number of aspects.

Theory sessions will include an introduction to i) innovation management tools, ii) entrepreneurship

models, iii) a variety of toolboxes for entrepreneurs, and iv) pharmaceuticals as a business area.

Furthermore, conditions for discovery, intellectual property rights, and patenting are introduced,

covering the structure of patent applications and concepts such as objective novelty, priority

principle, and inventive step. An account is also made of various aspects of patent literature, as

well as approaches to and searches within the pharmaceutical area. Moreover, legal framework

related to establishing a company in Denmark will be introduced, as will licencing and typical

pitfalls in contracts. These theoretical sessions will be complemented by illustrative case studies. In

parallel, students will apply these tools to develop a venture idea in groups of 3-5 students through

project work, in-class exercises, and interaction with

stakeholders, including considerations of i) intellectual property rights, ii) market/competition, iii)

scientific/technical development aspects, iv) clinical trial plans, and v) investment strategies,

ultimately resulting in the development of a business plan.

The purpose of the course is to provide students interested in developing their own ventures

and/or in entrepreneurial and innovation processes with a set of tools they can use to engage in

new ventures or innovation teams within the pharmaceutical area. Moreover, the course aims to

provide an overview of the significance of intellectual property rights in pharmaceutical research

and development. This is linked to current developments within pharmaceutical industry, how

this relates to entrepreneurial opportunities, as well as to strategic considerations of

market/competition, scientific/technical development aspects, clinical trial plans, and investment

strategies, illustrated by business case studies. To set this in practice, the students will develop a

business plan in groups of 3-5, to be presented/pitched and provided feedback on by other

students and the course team. thisFor this, students may either have an idea beforehand or will be

able to develop an idea with help from the course team. To facilitate the business plan

development, and to secure progression, a mid-course assessment will be held, and feedback

provided to the groups for the finalization of the business plans. The final outcome is that students

will be able to build on the knowledge and teamwork experiences from the course during their

entrepreneurial career, and in further graduate courses on specific topics within innovation,

entrepreneurship, and business development.

Learning Outcome

On completion of the course the student will be able to: Knowledge

• show an overview of concepts in entrepreneurship, developments in the pharmaceutics

area, and business opportunities related to this.

• explain principles of intellectual property rights and international patenting systems.

• explain the importance of an active intellectual property rights strategy for

pharmaceuticals (and related (bio)technologies) business development.

• show an overview of business development aspects, particularly relating to start-ups, in the

pharmaceutic area.

Skills

• assess current developments within pharmaceutical industry, and how this translates into

entrepreneurial business opportunities.

• identify innovative elements and its relationship to intellectual property rights.

• use professional databases to find relevant patents and patent applications.

• read and interpret patents and patent applications to assess the strengths/weaknesses and

freedom-to-operate situation.

• communicate ideas to stakeholders, including team members, investors, customers,

collaborators, and other potential partners

Competences

• provide an overview familiarity with the process of pharmaceuticals development.

• analyze and integrate open innovation and business model concepts and practices to

understand, on a basic level, how pharmaceutical companies operate and compete in the

market.

• navigate in the patent landscape surrounding a product and explain the different stages of

the patenting process, and requirements for obtaining a patent.

• analyze the commercial potential of inventions based on technological and medical

considerations, IP situation, and market analyses.

• describe and compare the different means to fund or finance inventions in order to

commercialize these including an introduction to business plans and raising venture capital

for the new company.

• develop and present a business plan integrating the aspects above.

• interact with external partners, both industrial and academic, as well as in virtual

organizations.

Literature

Selected documents including review articles, patent applications, and supplementary notes.


The course is designed to give students from a broad introduction to entrepreneurship within the

pharmaceuticals (and related (bio)technologies) area, and no prerequisites with

entrepreneurship are required. Students are expected to have a relevant background (e.g., from

the pharmaceutical, life, or health sciences).


Class and guest lectures will provide students with an overview of current developments within

pharmaceutical industry, and how these translate into entrepreneurial opportunities. They will also

cover aspects of intellectual property rights, stakeholder interactions, and business strategy

considerations, illustrated with case stories. As a core integrating activity of the course, students

will develop a business plan on a venture idea, integrating these aspects, and give a

presentation/pitch of their project. Furthermore, students will give and receive feedback on their

project work, will need to learn how to work and organize themselves in teams, and will practice to

communicate their business ideas.

Requirements regarding active participation

•Active with regards to questions and discussions in relation to lectures

and guest lectures

Business plan development (done in groups of 3-5)

- Active during group meetings with the group mentor

- Active in material generation, analysis, and business plan writing

- Active (presentation and questions/discussions) in half-time andfinal workshops

- Clear and substantial contributions to final business plan, and shared responsibility of overall

business plan

Two oral presentations (group-wise, but individual contributions required, one at half-time

seminar and one at final seminar, where business plan is presented orally. In addition, each group

should hand in a written business plan/report.

Report evaluated on a group level, but activity and progress evaluated individually.

Feedback form

Written Oral

Individual Collective



Sign up


Open for credit transfer students and other external students. Apply here: Credit

transfer students:

http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/ Other

external students: http://healthsciences.ku.dk/education/exchange_guest_students/guest-

students/




Credit

7,5 ECTS

Type of assessment

Oral examination, 20 minutes Course

participation




Continuous assessment includes:

•development of a business plan in groups of 3-5

•oral group presentation of the partial business plan (mid-course evaluation)

•feedback to other groups’ business plan

•oral group presentation of the final business plan

•presence during lectures

•active partipation during the course

Oral presentation of the partial business plan (mid-course evaluation). Weight: 25%. Oral

presentation of the business plan developed. Weight:

Aid

All aids allowed

Marking scale

passed/not passed

Censorship form



On completion of the course the student will be able to: Knowledge

• show an overview of concepts in entrepreneurship, developments in the pharmaceutics

area, and business opportunities related to this.

• explain principles of intellectual property rights and international patenting systems.

• explain the importance of an active intellectual property rights strategy for

pharmaceuticals (and related (bio)technologies) business development.

• show an overview of business development aspects, particularly relating to start-ups, in the

pharmaceutic area.

Skills

• assess current developments within pharmaceutical industry, and how this translates into

entrepreneurial business opportunities.

• identify innovative elements and its relationship to intellectual property rights.

• use professional databases to find relevant patents and patent applications.

• read and interpret patents and patent applications to assess the strengths/weaknesses and

freedom-to-operate situation.

• communicate ideas to stakeholders, including team members, investors, customers,

collaborators, and other potential partners

Competences

• provide an overview familiarity with the process of pharmaceuticals development.

• analyze and integrate open innovation and business model concepts and practices to

understand, on a basic level, how pharmaceutical companies operate and compete in the

market.

• navigate in the patent landscape surrounding a product and explain the different stages of

the patenting process, and requirements for obtaining a patent.

• analyze the commercial potential of inventions based on technological and medical

considerations, IP situation, and market analyses.

• describe and compare the different means to fund or finance inventions in order to

commercialize these including an introduction to business plans and raising venture capital

for the new company.

• develop and present a business plan integrating the aspects above.

• interact with external partners, both industrial and academic, as well as in virtual

organizations.

• integrating the aspects above.

Workload

Category Hours

Lectures 20

Preparation 90

Project work 80

Colloquia 7

Guidance 9

Total 206

Course information

Language

English

Course code

SFKKIF105U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 3

Schedule

B

Course capacity

30 students





Course Coordinators

Martin Malmsten ([email protected])




Advarsel





SFKKIL008U Klinisk farmaci

Fold alle ud Årgang 2018/2019

Engelsk titel

Clinical Pharmaci

Uddannelse

kandidatuddannelsen i farmaci - valgfri

kandidatuddannelsen i farmaceutisk videnskab - valgfri



Kursusindhold

• Introduktionsseminar 1 x 45 min

• Kliniske forelæsninger 8 x (2 x 45 min)

• Introduktion til praktik ophold 1 x 50 min

• 1 uges praktikophold

• Evalueringsseminar (klinisk del) 4 x 50 min

• Farmakoterapi forelæsninger 7 x (2 x 45 min)

• Farmakoterapi - intro til projektarbejde 2 x 50 minutter

• Evalueringsseminar (farmakoterapidel) 4 x 50 minutter

Målbeskrivelser

Formålet med studieenheden er at give de studerende indsigt i patienters sygdomssituation, så

de kan vurdere den medicinske behandling og herudfra give faglig vejledning til patienten, lægen

og andre, der er involveret i patientens medicinske behandling Studieenhedens formål er

endvidere at give de studerende tilstrækkelig klinisk baggrund til at kunne fungere i

medicinalindustrien inden for de farmaceutiske og kliniske områder, samt at samarbejde med

læger og sygeplejersker i den primære og sekundære sundhedstjeneste.

Efter endt kursus forventes den studerende at kunne:

Viden

• anvende fagene patologi, fysiologi, farmakologi og farmaci i forbindelse med den praktiske

anvendelse af lægemidler i patientbehandlingen

• beskrive sygdomme, deres medicinske behandling, pleje af patienter, brugen af

laboratoriedata og på baggrund heraf evaluere den medicinske behandling

Færdigheder

• deltage i beslutninger angående patienters lægemiddelterapi og vurdere

administrationsform og dosisregime.

• rådgive patienter og sundhedspersonale om optimal anvendelse af lægemidler

• udføre en medicingennemgang og evaluere den medicinske behandling

Kompetencer

• opnå indsigt og forståelse for samarbejdet mellem kliniske specialer (f.ex intensiv terapi og

klinisk mikrobiologi) og samarbejdet mellem de forskellige sundhedsprofessioner

• diskutere lægemidlers formuleringsmæssige egenskaber og de fysiologiske forholds

indflydelse på lægemiddelstoffets afgiftshastighed, absorption og effekt.

• diskutere formuleringsprincippet for et lægemiddel i relation til lægemidlets kliniske

anvendelse.

Undervisningsmateriale

• R. Walker & C. Edwards, Clinical Pharmacy and Therapeutics, 4rd ed. 2007, Churchill

Livingstone, ISBN-13: 9780443102851

• Behandlingsvejledninger fra IRF's og medicinske selskabers hjemmesider

• Forelæsningsnoter: Lægges på kursushjemmesiden

Anbefalede faglige forudsætninger

Undervisningen er tilrettelagt under den forudsætning, at de studerende har opnået en viden

svarende til indholdet i følgende studieenheder: Lægemiddelformulering, farmakologi (almen og

organrelateret), og farmakoterapi.

Undervisningsform

•Introduktionsseminar 1 x (2 x 50 min)

•Kliniske forelæsninger 8 x (2 x 45min) sammen med FFKKB9011 (Klinisk Praktik)

•1 uges praktikophold

•Evalueringsseminar (klinisk del) 4 x 50 min

•Farmakoterapi forelæsninger 7 x (2 x 45 min)

•Farmakoterapi - intro til projektarbejde 2 x 4 timer

•Evalueringsseminar (farmakoterapidel) 2x 50 minutter

Bemærkninger

Det faglige indhold i kurset overlapper med Pharmacotherapy Practise.

Feedbackform

Mundtlig

Individuel

Kollektiv

Peerfeedback (studerende giver hinanden feedback)

Tilmelding

Selvbetjeningen på KUnet

Udbydes til merit- og tompladsstuderende. Søg via disse links:


http://sund.ku.dk/uddannelse/efter-og-videreuddannelser/enkeltfag/ Der er

kun begrænset eller ingen pladser til eksterne studerende.

Eksamen (SFKKIL008U - løbende bedømmelse)

Point

7,5 ECTS

Prøveform

Kursusdeltagelse

Skriftlig aflevering

For at opnå kursusattest skal den studerende:

- Udvise tilfredsstillende deltagelse ved seminaret.

- Udvise tilfredsstillende gennemført klinikophold (fremmøde hele ugen)

- Aflevere en tilfredsstillende individuel skriftlig rapport over klinikopholdet samt aflægge en

individuel mundtlig fremlæggelse og diskussion af rapportens indhold.

- Aflevere en tilfredsstillende grupperapport over et udvalgt lægemiddel til en udvalgt patient

samt aflægge en tilfredsstillende gruppevis mundtlig præsentation og efterfølgende diskussion af

rapportens indhold.

Bedømmelsesform

bestået/ikke bestået

Censurform

Ingen ekstern censur

Kriterier for bedømmelse

For at bestå kurset skal den studerende kunne:

Viden

• anvende fagene patologi, fysiologi, farmakologi og farmaci i forbindelse med den praktiske

anvendelse af lægemidler i patientbehandlingen

• beskrive sygdomme, deres medicinske behandling, pleje af patienter, brugen af

laboratoriedata og på baggrund heraf evaluere den medicinske behandling

Færdigheder



• deltage i beslutninger angående patienters lægemiddelterapi og vurdere

administrationsform og dosisregime.

• rådgive patienter og sundhedspersonale om optimal anvendelse af lægemidler

• udføre en medicingennemgang og evaluere den medicinske behandling

Kompetencer

• opnå indsigt og forståelse for samarbejdet mellem kliniske specialer (f.ex intensiv terapi og

klinisk mikrobiologi) og samarbejdet mellem de forskellige sundhedsprofessioner

• diskutere lægemidlers formuleringsmæssige egenskaber og de fysiologiske forholds

indflydelse på lægemiddelstoffets afgiftshastighed, absorption og effekt.

• diskutere formuleringsprincippet for et lægemiddel i relation til lægemidlets kliniske

anvendelse.

Arbejdsbelastning

Kategori Timer

Forelæsninger 32

Forberedelse 82

Praktiske øvelser 42

Projektarbejde 50

I alt 206

Kursusinformation

Sprog

Dansk

Kursuskode

SFKKIL008U

Point

7,5 ECTS

Niveau

Kandidat

Varighed

1 blok

Placering

Blok 1

Skemagruppe

A (tirs 8-12 + tors 8-17) og B

Særlige forhold: Af hensyn til planlægningen af klinikopholdet skal den studerende, som ønsker

at følge andre kurser i blok 1, være opmærksom på at vælge et kursus, hvor der ikke er mødepligt

i uge 40 eller 41 samt tirsdage kl. 8-12 og torsdage kl. 8-17 men kun i september.

Kursuskapacitet

36 studerende

Efter- og videreuddannelse Studienævn

Studienævn for de Farmaceutiske Videnskaber

Udbydende institut

Institut for Lægemiddeldesign og Farmakologi

Kursusansvarlige

Lona Louring Christrup ([email protected])


Gemt den 22-12-2017









Advarsel





SLVKB0381U Methods and Procedures in Clinical Drug

Development


Education

MSc Programme in Pharmaceutical Sciences: Track III (English programme) - compulsory





Content

The regulatory guidelines and principles around pre-clinical and clinical research will be

reviewed. During the last weeks of the course, the students will develop a clinical trial protocol

based on a medical case and prepare a project report. The core focus areas will be:

• Regulatory requirements for clinical trial protocols in Denmark and abroad

◦ The Danish Medicines Agency

◦ The Ethics Committee system

◦ Data Protection Agency

• Principles for the development of pre-clinical documentation

◦ Drug discovery

◦ Preclinical safety pharmacology and toxicology

• Clinical drug development

◦ Clinical research methodology – the randomised clinical study design

◦ Clinical trials

◾ Human pharmacology

◾ Therapeutic exploratory

◾ Therapeutic confirmatory

◾ Therapeutic use

◾ Health economics and outcomes studies

◦ Good Clinical Practice

◦ The pharmaceutical industry’s involvement in clinical development plans and

protocols

◦ The conduct and monitoring of clinical trials

◦ Clinical supply chain activities and study drug management

◦ Safety surveillance and pharmacovigilance

◦ Clinical research from the investigator perspective

◦ Data management

◦ Medical writing and study publications

◦ Medical devices

◦ Quality assurance, audits and inspections

Learning Outcome

The aim of the course is to give students knowledge about the preclinical and clinical

methodology used to generate the evidence necessary for getting marketing authorisation of a

drug. Furthermore, to give insight into the ethical, regulatory and guideline framework around

clinical drug development. The course provides a description of the main areas, processes and

key functions in the pharmaceutical industry that contributes to the planning, design and

practical conduct of clinical trials.

After completing the course the student is expected to be able to:

Knowledge

• explain preclinical and clinical research methods used as basis for the approval of drugs.

• explain ethical, regulatory and guideline requirements of clinical studies.

• define, summarize and identify the main areas, processes and key functions in the

pharmaceutical industry that contributes to planning, design and practical conduct of

clinical drug development.

Skills

• describe and analyze the regulatory requirements for pre-clinical and clinical trials used to

register drugs.

• put structure to and evaluate the clinical development process of a drug in the

pharmaceutical industry

• describe and master the main principles of Good Clinical Practice, including

roles/responsibilities of sponsors, monitors and investigators.

• assess and discuss the main quality assurance aspects and ethical dimensions of

importance in clinical drug development.

Competences

• independently develop, plan, coordinate and implement clinical trial protocols for studies

in healthy volunteers and patients across all 4 phases of Drug Development.

Literature

Laws, documents, recommendations, circulars, guidelines and scientific papers.

Formal requirements

Non.


Course teaching is based on the assumption that students have knowledge corresponding to the

content of the courses Basic Pharmacology, Organ-related Pharmacology, Pharmacotherapy,

Toxicology and Drug Production.


Lectures: 40

Classroom discussions: 6

Case project and report: 70

Feedback form

Oral



Sign up









Exam (SLVKB0381U Continuous Assessment)

Credit

7,5 ECTS

Type of assessment

Written assignment



* develop a project report of clinical trial protocol based on a medical case. The report will be

developed during the last weeks of the course.

* Participate in the internal evaluation of the project report

* Participate satisfactorily throughout the course.

Participation in group work and presentation of project report is mandatory.

Marking scale

passed/not passed

Censorship form




Knowledge

• explain preclinical and clinical research methods used as basis for the approval of drugs.

• explain ethical, regulatory and guideline requirements of clinical studies.

• define, summarize and identify the main areas, processes and key functions in the

pharmaceutical industry that contributes to planning, design and practical conduct of

clinical drug development.

Skills

• describe and analyze the regulatory requirements for pre-clinical and clinical trials used to

register drugs.

• put structure to and evaluate the clinical development process of a drug in the

pharmaceutical industry

• describe and master the main principles of Good Clinical Practice, including

roles/responsibilities of sponsors, monitors and investigators.

• assess and discuss the main quality assurance aspects and ethical dimensions of

importance in clinical drug development.

Competences

• independently develop, plan, coordinate and implement clinical trial protocols for studies



in healthy volunteers and patients across all 4 phases of Drug Development.

Workload

Category Hours

Lectures 40

Preparation 80

Theory exercises 6

Preparation 10

Project work 70

Total 206

Course information

Language

English

Course code

SLVKB0381U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 2

Schedule

B

Course capacity

60 students (20 seats reserved students from MSc Programme in Pharmaceutical Sciences: Track

III)





Course Coordinators

Morten Andersen ([email protected])




Advarsel





SFKKB9001U Pharmacokinetics and

Pharmacodynamics


Education





Content

Lectures covering PK-PD relationships, as well as distribution, metabolite kinetics, effect at

receptor and ionchannel level, effect measurement, dose-effect relationships, population

methods, simulation of PK-PD relationships and variability in PK-PD response and dosing to

different patient populations.

Computer sessions for pharmacokinetic pharmacodynamic modeling using the program Phoenix

WinNonlin and Microsoft Excel.

Learning Outcome


Knowledge

• demonstrate knowledge of pharmacokinetic (PK) and pharmacodynamic (PD) in the

individual as well as the population

• understand how to calculate PK and PD parameters and use them in a quantitative

description of the interaction between a drug and the body over time.

• obtain knowledge on variability in patient populations

Skills

• obtain insight and hands-on experience with pharmacokinetic and –dynamic data analysis,

based on different examples of plasma concentration-time course linked to therapeutic

response.

• obtain experience with the modelling software Phoenix WinNonlin and Microsoft Excel for

data analysis.

• apply knowledge on variability in patient populations to a PKPD analysis that can be used

to describe variability in response in different patient segments and in drug research and

illustrate development within the pharmaceutical industry.

Competences

• design dosing strategies in different clinical situations based on their knowledge about

PKPD (e.g. taking variations such as demographics, organfunction, pharmacogenetics,

comobidity and interactions into account).

• design experiments for the drug research and development based on their knowledge

about PKPD

Literature

• M. Rowland and T. Tozer, Clinical Pharmacokinetics and Pharmacodynamics, ed. 4, 2011

• Notes and lecture hand-outs available on the course homepage


Participation and exam in either Basic Pharmacology or Principles of Pharmacology or similar, as

the student should be familiar with the basic pharmacokinetic parameters and calculations,

concepts determining variability in order to suggest individual dosing as well as knowledge and

competence for reasoning on PKPD information


Lectures: 21 lectures

Tutorials/computer sessions: 15 hours

Feedback form

Oral

Der gives løbende mundtlig feedback ved diskussion ved opgaveregningstimer og

computerøvelser

Sign up











Exam (SFKKB9001E - written examination)

Credit

7,5 ECTS

Type of assessment

Written examination, 3 hours under invigilation

Examiners: Course teachers

Aid


Permitted aids: Textbooks, all written course material from the homepage.





• Paint




• Adobe reader


• Maple

• USB access – for usb stick with notes etc.

Marking scale


Censorship form




Knowledge

• demonstrate knowledge of pharmacokinetic (PK) and pharmacodynamic (PD) in the

individual as well as the population

• understand how to calculate PK and PD parameters and use them in a quantitative

description of the interaction between a drug and the body over time.

• obtain knowledge on variability in patient populations

Skills

• obtain insight and hands-on experience with pharmacokinetic and –dynamic data analysis,

based on different examples of plasma concentration-time course linked to therapeutic

response.

• obtain experience with the modelling software Phoenix WinNonlin and Microsoft Excel for

data analysis.

• apply knowledge on variability in patient populations to a PKPD analysis that can be used

to describe variability in response in different patient segments and in drug research and

illustrate development within the pharmaceutical industry.

Competences

• design dosing strategies in different clinical situations based on their knowledge about

PKPD (e.g. taking variations such as demographics, organfunction, pharmacogenetics,

comobidity and interactions into account).

• design experiments for the drug research and development based on their knowledge

about PKPD

Workload

Category Hours

Lectures 21

Exam 3

Preparation 167

Theory exercises 15

Total 206

Course information

Language

English

Course code

SFKKB9001U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 1

Schedule

A

Course capacity

30 students


Study board




Course Coordinators

Trine Meldgaard Lund ([email protected])











Advarsel





SFKKA9021U Principles and Practice of Bioanalysis


Education




MSc Programme in Pharmaceutical Sciences (English programme)- elective

MSc Programme in Environmental Science (SCIENCE) - restricted elective

Content

The course is intended for (a) students specializing in bioanalysis (determination of

pharmaceuticals in biological fluids), and for (b) students with need for improved general

knowledge and skills in analytical chemistry / pharmaceutical chemical analysis. The latter

students are typically master students using analytical techniques during the experimental work

for the master thesis. The course focuses both on theoretical and practical aspects of

bioanalysis. The first part of the course teaches the principles of major bioanalytical techniques

at high level (lectures):

• Sample preparation (protein precipitation, liquid extraction, solid-phase extraction)

• Liquid chromatography

• Liquid chromatography-mass spectrometry

• Gas chromatography

• Gas chromatography-mass spectrometry

• Capillary electrophoresis

The second part of the course teaches the use of the above techniques at high level for the

following purposes (lectures):

• Determination of small molecule pharmaceuticals in biological fluids (blood, urine,

saliva, dried blood spots)

• Determination of biopharmaceuticals in biological fluids

• In-vitro metabolism studies of small molecule pharmaceuticals

Application areas include therapeutic drug monitoring, in-vitro metabolism studies,

forensictoxicology, and doping analysis.

The third part of the course focus on reading and understanding research articles in bioanalysis

related to the techniques and applications outlined above, and include student presentation of

selected articles.

The fourth part of the course comprises laboratory exercises related to the techniques and

applications outlined above.

Learning Outcome


Knowledge

• Have an in-depth theoretical understanding of the major techniques used in bioanalysis of

pharmaceuticals

• Understand the individual steps in procedures for determination of small molecule

pharmaceuticals and biopharmaceuticals in biological fluids

• Understand the individual steps of in-vitro metabolism studies of small molecule

pharmaceuticals

Skill

• Be able to perform practical bioanalytical work according to published / existing

procedures

• Know and be able to use a broad number of separation and detection principles as well as

sample preparation techniques used for bioanalysis.

• Understand the principles behind and use the analytical chemical instrumentation needed

for high sensitivity analysis of samples of biological origin.

• Judge and use the relevant original analytical chemical literature, handbooks and

databases.

Competence

• Understand and perform bioanalytical chemical work.

• Develop new analytical chemical methods for analysis of samples of biological origin (e.g.

urine, plasma, serum, faeces, saliva, synovial liquid, plant materials etc.).

• Design sampling and storage protocols for in vivo studies of drug substances.

Literature

• Steen Honore Hansen, Stig Pedersen-Bjergaard: Bioanalysis of Pharmaceuticals: Sample

Preparation, Chromatography and Mass Spectrometry, ISBN: 978-1-118-71682-3, Wiley

(2015)

• Additional course materials such as manuals and scientific papers are availabe from the

course homepage


Course teaching is based upon the assumption that the student has acquired basic skills in

instrumental analytical chemistry corresponding to at least a 7.5 ECTS course at bachelor level. In

addition general knowledge within the areas of organic chemistry, inorganic chemistry, physical

chemistry, analytical chemistry, biochemistry, pharmacology, toxicology, and drug development

at bachelor level is expected.


Lectures: 32 hours

Laboratory exercises: 24 hours

Feedback form

Oral

Collective

Sign up









Exam (SFKKA9021E- written examination)

Credit

7,5 ECTS

Type of assessment

Written examination, 2 timer under invigilation

Examination type:

2 hour multiple-choice test.

Examination design:

The multiple choice-test is made up of a number of statements (typically 50) to which the student

has to decide whether they are true or false.


In order to be able to take the exam the oral presentation of the "Independent Study Activity"

must be approved and the student must have completed all the laboratory exercises.

Aid






• Paint




• Adobe reader

• ChemDraw


• Maple

• USB access – for usb stick with notes etc.



Marking scale

passed/not passed

Censorship form




Knowledge

• Have an in-depth theoretical understanding of the major techniques used in bioanalysis of

pharmaceuticals

• Understand the individual steps in procedures for determination of small molecule

pharmaceuticals and biopharmaceuticals in biological fluids

• Understand the individual steps of in-vitro metabolism studies of small molecule

pharmaceuticals

Skill

• Be able to perform practical bioanalytical work according to published / existing

procedures

• Know and be able to use a broad number of separation and detection principles as well as

sample preparation techniques used for bioanalysis.

• Understand the principles behind and use the analytical chemical instrumentation needed

for high sensitivity analysis of samples of biological origin.

• Judge and use the relevant original analytical chemical literature, handbooks and

databases.

Competence

• Understand and perform bioanalytical chemical work.

• Develop new analytical chemical methods for analysis of samples of biological origin (e.g.

urine, plasma, serum, faeces, saliva, synovial liquid, plant materials etc.).

• Design sampling and storage protocols for in vivo studies of drug substances.

Students are evaluated from the participation in the laboratory exercises as well as from the

multiple choice examination and their "Independent Study Activity" where they critically present

analytical chemical literature.

Workload

Category Hours

Lectures 32

Preparation 150


Total 206

Course information

Language

English

Course code

SFKKA9021U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 1

Schedule

C

Course capacity

30 students





Course Coordinators

Nickolaj J. Petersen ([email protected])

Hovedansvarlig

Stig Pedersen-Bjergaard ([email protected])


Lecturers

Stig Pedersen-Bjergaard (qnr932)

Nickolaj J. Petersen (njl271)

Tam Nguyen (kng128)

Kasper Dyrberg Rand (qvw197)










Advarsel

Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan

se, du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har

brug for, er linket til den offentlige version. Kontakt venligst den person, der har givet dig

linket (eller den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte

offentlige version.

SFKKB9081U Theories and Research Methods in Social and

Clinical Pharmacy Expand all Volume 2018/2019

Education

MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes

cand.scient.pharm and cand.pharm) - elective



Content

The course covers use of theories and research methods commonly used within the fields of

social and clinical pharmacy. These theories and methods are typically from the social

sciences and are relevant to most areas where pharmacists work.

The course deals with why, how, and when theories and models are used in the social

sciences. It also presents a selection of specific theories and models used in social and

clinical pharmacy. Also epistemology and methodological perspectives are presented, e.g.

consequences of choosing (or not choosing) epistemic and methodological stand-points.

Further, the course includes a general overview of research designs and relevant methods

within social pharmacy and clinical pharmacy. Some methods are taught more in-depth and

students also get to use some of them in a minor field study group assignment. These

methods are:

• Qualitative methods: observations, individual interviews and focus groups

• Quantitative methods: surveys and register-based studies

Learning Outcome


Knowledge

• Describe central theories and methods within social and clinical pharmacy

• Explain how theories and research methods are used in social and clinical pharmacy

• Describe the concepts of epistemology and methodology, incl. the consequences of

choosing epistemic and methodological stand-points

Skills

• Critically assess scientific studies within social and clinical pharmacy

• In a group, conduct a minor field study, including research question definition, data

collection and analysis

Competence

• Design, and implement, a minor research project within social and clinical pharmacy,

including applying theory and choosing relevant method(s).

Literature

Robson C. Real World Research. John Wiley and Sons Ltd. 3rd edition or later.

Relevant scientific papers and book chapters

Formal requirements

Non.


Lectures, seminars, minor field study, individual assignments and group work.

Feedback form

Oral

Collective


Sign up







Exam (SFKKB9081U - continuous assessment)

Credit

7,5 ECTS

Type of assessment




- Attend mandatory sessions

- submit individually written assignments, that should be approved prior to the individual oral



examination

- in groups be part of a minor field study, including written and oral presentations

- pass an individual oral examination based on the written group report


Aid

All aids allowed

Marking scale

passed/not passed

Censorship form



The following elements must be demonstrated to obtain the course certificate:

Knowledge

• Describe central theories and methods within social and clinical pharmacy

• Explain how theories and research methods are used in social and clinical pharmacy

• Describe the concepts of epistemology and methodology, incl. the consequences of

choosing epistemic and methodological stand-points

Skills

• Critically assess scientific studies within social and clinical pharmacy

Competence

• Design a minor research project within social and clinical pharmacy, including applying

theory and choosing relevant method(s)

Workload

Category Hours

Lectures 20

Preparation 104

Seminar 10


Guidance 2

Total 206

Course information

Language

English

22-12-2017

Course code

SFKKB9081U

Credit

7,5 ECTS

Level

Full Degree Master

Duration

1 block

Placement

Block 2

Schedule

A

Course capacity

60 students





Course Coordinators

Lourdes Cantarero Arevalo ([email protected]) Sofia

Kälvemark Sporrong ([email protected])



block- and schedule placement of elective courses...spring 2019 autumn 2019 biopharmaceuticals:...

Documents