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الهيئة القومية لضمان جودة التعليم واالعتماد
University: Alexandria
Faculty: Medicine
Programme Specifications
(Academic year: 2015/2016 )
A. Basic Information:
1. Program title: MD degree in clinical pharmacology
2. Department(s) offering the program: Department of clinical pharmacology
3. Date of program specifications approval: /1 /2016
B. Professional Information
1- Program Aims
By the end of the program the candidate will be able to
1.1 Understand the fundamental information and principles underlying the use of pharmacological agents.
1.2 Conduct appropriate medical research aiming at improving the quality of patient care through optimal
medication management based on sound pharmaco-therapeutic principles
1.3 Apply analytical and critical methods when dealing with medical problems.
1.4 Identify pharmacological and medical problems and suggest innovative solutions.
1.5 Use technological tools needed in his practice perfectly.
1.6 Communicate and lead team in systematic professional manner.
1.7 Commit to continuous self-development and transfer of his medical experience
1.8 Develop the ability to critically review the scientific literature, critically analyze information, synthesize
and summarize conclusions
3- Benchmarks:
3.1 Department of Pharmacology University of Oxford (http://www.pharm.ox.ac.uk/)
3.2 Department of Clinical Pharmacology. Medical University of Vienna
(http://klpharm.meduniwien.ac.at/)
3.3 American board of clinical pharmacology http://www.abcp.net/instructions.pdf
3.4 The Irish Committee on Higher Medical Training Curriculum For Higher Specialist Training In
Clinical Pharmacology. October, 2002.
http://www.rcpi.ie/EducationAndTraining/HMT%20%20Specialties%20Library/ICHMT%20-
%20Clinical%20Pharmacology%20Therapeutics%20-%20October%202002.pdf
3.5 Specialty training curriculum for clinical pharmacology And therapeutic by Joint Royal Colleges Of
Physicians Training Board-UK; May 200
http://www.pmetb.org.uk/fileadmin/user/QA/Curricula/Approved_curricula/CLINICAL_PHARMACOLO
GY_AND_THERAPEUTICS/CPT_3_Jul_07_Curr_0010.pdf
الهيئة القومية لضمان جودة التعليم واالعتماد
Academic
Reference
Standards
ILOs
A. Knowledge and
understanding
A1. Discuss the pharmacology and possible effects of a
drug and integrate other disciplines with clinical
pharmacology.
A2. Review the pharmacodynamic and pharmacokinetic
concepts that will help in understanding basic drug
actions.
A3. Recognize the essential basics of pharmacological
research
A4. List the available targets of drug action
A5. Describe the characteristic specification of each
target
A6. Classify each target to different subcategories and
superfamilies that have been so far enrolled
A7. Identify linking signaling cascade of each target and
potential sites where a drug can possibly intervene
starting at cell surface down to nuclear modulation and
gene expression or repression
A8. Describe the final outcome of modulating the
different selected targets in terms of survival and death
A9. Recognize the importance of dose adjustment of
some antimicrobial drugs
A10. Evaluate the importance of drug monitoring of
certain drugs
A11. Assess the plasma level of certain
immunosuppressant drugs
A12. Discuss the pharmacokinetics of drugs with
narrow therapeutic index
A13. Distinguish Phase I Clinical Studies
a.14 Describe Pharmacokinetic and Pharmacodynamic
Considerations in the Development of Biotechnology
Products and Large M
olecules
A15 Distinguish Design of Clinical Development
Programs
a.16 Distinguish Role of the Administration (e.g. FDA)
in Guiding Drug Development
a.17Distinguish clinical applications of Drug Discovery
and development
A18. Design a clinical trial, collect data, analyze and
الهيئة القومية لضمان جودة التعليم واالعتماد
interpret results.
A19. Review recent guidelines in management of
common diseases
A20. Understand concept of drug safety
A21. Recognize adverse drug reactions
A22. Recognize glossary of terms used in
Pharmacovigilance
A23 Recognize recent updates in measuring costs and
sensitivity analysis
A24. Discuss toxicity tests
A25. Discuss applicable lines of management in drug
poisoning
A26. Discuss drug teratogens.
A27. Discuss drug related carcinogenesis
A28 Identify patient-reported health outcomes and
health-related quality of life measures.
A29. Review pharmacokinetic and pharmacodynamics
of anticancer drugs
A30. Understand appropriate pharmacotherapeutic
regimens in cardiovascular diseases in critically ill
patients
A31. Recognize specific problems of prescribing for
critically ill cardiac patient
A32. Recognize guidelines for managing critically ill
cardiac patient
A33. Recognize Basic immunologic Structure and
Function
A34. Recognize recent advances in Immunodeficiency
diseases
A35. Discuss Recombinant Proteins used in
Immunotherapy
A36. Discuss the drugs used in immunosuppressive
therapy
A37. Discuss the diagnosis and management of Allergic
diseases
A38. Discuss the Disease-modifying antirheumatic
drugs (DMARDs)
A39. Discuss Autoimmune Diseases
A40. Discuss the role of drugs in Transplantation
immunology
A41. Discuss in details types, preparations, toxicities of
active principles in herbal medicinal plants
B. Intellectual B1. Evaluate and provide drug information
الهيئة القومية لضمان جودة التعليم واالعتماد
skills B2. Formulate evidence-based treatment strategies for
important emergency situations
B3. Correlate the action of drugs on their targets to their
abilities to achieve a specific therapeutic outcome
B4. Predict the possibility of maximizing drug benefits
and minimizing adverse effects based on the acquired
knowledge linked to the studied signaling cascades
B5. Analyze areas of signaling cross talk where a single
drug can act instead of several drugs
B6. Allocate potential signaling molecules that could be
a target for new drug development
B7. Suggest a new targets where drugs can be used in
regenerative therapy versus those that can be eliminate
undesirable cell lines
B8. Design the therapeutic regimen of drugs depending
on the desired steady state plasma level
B9. Design Phase I Clinical Studies
B10. Apply Pharmacokinetic and Pharmacodynamic
Considerations in the Development of Biotechnology
Products and Large Molecules
B11. Construct Design of Clinical Development
Programs
B12. Construct Role of the Administration (e.g. FDA) in
Guiding Drug Development
b.13 Criticize clinical applications of Drug Discovery
and development
B14. Assess the presence or absence of significant
difference between different groups of the clinical trial,
using the appropriate statistical test
B15. Critically analyses papers
B16. Formulate evidence-based treatment strategies for
important clinical situations.
B17. Choose tools, techniques and methodologies in
dug safety evaluation
B18. Assess impact of adverse drug reactions on
adherence of patients to drugs
B19. Evaluate principal methodological challenges in
the reporting, analysis and interpretation of safety data
in clinical trials
B20. Calculation of average costs
B21- Share in six studies
B22. Explain toxicokinetics
B23. Choose alternative drugs to avoid potential
الهيئة القومية لضمان جودة التعليم واالعتماد
drug interactions.
B24 Apply the health outcomes and health-related
quality of life measures to pharmacotherapy.
B25 Analyze relevant information to determine drug
therapy problems, urgency, and priority for a given
clinical situation
B26. Apply the standards of practice for clinical
pharmacology to the critical care practice environment
using a standard process of care.
B27. Identify the best practice patterns to facilitate care
of the critically ill cardiac patient
B28. Choose suitable drugs for treatment of
immunological diseases .
B29. Choose alternative drugs to avoid potential drug
interactions
B30 Use evidence based data to assess the proper use of
herbal preparations
C. Professional
skills
C1. Add to the practice of the specialty and research
through creativity & innovation
C2. Assessment of drug regimens in different clinical
situations in the hospitalized patients
C3. Criticize specific drugs in specific situations
C4. Use computer programs to assess the level of
significance between different groups of a study
C5. Implement drug safety on rational drug use
C7. Monitor adverse drug reactions
C8 Acquire the technical skills (e.g. developing medical
decision trees
C9. Interpret images/ diagram Social/ethical skills (e.g.
interpretation of results at the population level,
understanding of ethical issues)
C10. Acquire personal/professional skills (e.g.
functioning within an organization
C11. Apply recent advances in methodology and
laboratory technology in drug research and clinical
investigations.
D. General and
transferrable
D1. Hold skills to critically evaluate evidence presented
الهيئة القومية لضمان جودة التعليم واالعتماد
skills by publications
D2. Acquiring new communication skills in designing
and delivering talks and lectures
D3. Train in team working
D4. Retreive methods for data search and information
analysis
D5. Recognize tools for critique and peer reviewing
D6. Communicate and share ideas with professors to
Use the computer aided decision making from drug
discovery in pharmacoeconomic
D7 Communicate and collaborate within a team
Application level
D8. Participate in Conceptualization level (e.g. one can
develop a new decision tree)
D9. Within a team design a research project done in
Alexandria Faculty Medicine about pharmacoeconomic
of neuropathic pain killers, antidiabetic,
antihypertensive
D10. Share in improving the quality of practice and
patient care in Alexandria
D11. Share in activities of (ISPOR= International
Society for Pharmacoeconomics and Outcome research)
D12. Communicate and share ideas with professors to
Use the computer aided evidence based data regarding
herbs
D13. Communicate and collaborate within a team able
to understand and refined food-drug herb interaction or
allergy
D14. Participate in experimental studies
D15. Within a team design a research project done in
الهيئة القومية لضمان جودة التعليم واالعتماد
Alexandria Faculty Medicine regarding herbal or
homeopathic modulation of neuropathic pain killers,
antidiabetic, antihypertensive
D16. Share in completion of a national research in
Alexandria Somuaha hospital
E. Attitudes and
ethical
behavior
E1. Apply regulations and ethics that govern physicians
in promotion and detailing of drugs.
E2. Obtain consent that is truly informed
E3. Manage special challenges of performing clinical
research in vulnerable populations
E4. Manage confusion of roles in academic medical
centers and problems with duplicative, interactive, or
conflicting drug treatment plans
E5. Integrate with other members of medical team to
provide the patients the appropriate medical care
E6. Apply regulations and ethics during laboratory work
on experimental animals
E7. Show respect to professors, colleagues, other
members of medical team and to patients.
الهيئة القومية لضمان جودة التعليم واالعتماد
Matrix of Program ILOs/Courses ILO
Course
A1 A2
A3
A4-7
A8
A9 -12
A13-17
A18 A19
A20- 22
A23 A24-27
A28
A29.
A30-32
A33-40
A41
Advanced Internal medicine × × ×
Pharmacology Updates I × × ×
Pharmacology Updates II × × Advanced clinical
pharmacokinetics and
pharmacodynamics
× × ×
Advanced Drug Discovery
and development. ×
Biostatistics and data
management in clinical trials ×
Advanced
Neuropharmacology × × ×
Advanced Pharmacotherapy. × × ×
Drug Safety. × Pharmacoeconomic
Applications. ×
Advanced toxicokinetics &
Drug poisoning ×
Health Outcomes and
Health-Related Quality of
Life.
×
Oncology for Clinical
pharmacology. × × × ×
Acute Care Cardiology ×
Clinical Immunology ×
Herbal use in therapy ×
الهيئة القومية لضمان جودة التعليم واالعتماد
ILO
Course
B1 B2
B3-4
B5-7
B8 B9-13
B14-15
B16 B17-19-
B20-21
B22- 23
B24 B25
B26-27
B28-29
B30
Advanced Internal medicine × × ×
Pharmacology Updates I × × ×
Pharmacology Updates II × × Advanced clinical
pharmacokinetics and
pharmacodynamics
×
Advanced Drug Discovery
and development. ×
Biostatistics and data
management in clinical trials ×
Advanced
Neuropharmacology × ×
Advanced Pharmacotherapy. × × ×
Drug Safety. × Pharmacoeconomic
Applications. ×
Advanced toxicokinetics &
Drug poisoning ×
Health Outcomes and
Health-Related Quality of
Life.
×
Oncology for Clinical
pharmacology. ×
Acute Care Cardiology ×
Clinical Immunology ×
Herbal use in therapy ×
ILO
Course
C1 C2 C3 C4 C5-7 C8-10
C11- C12 C13-14
Advanced Internal medicine × × ×
Pharmacology Updates I × ×
Pharmacology Updates II Advanced clinical
pharmacokinetics and
pharmacodynamics
×
Advanced Drug Discovery
and development. ×
Biostatistics and data
management in clinical trials ×
Advanced
Neuropharmacology × × ×
Advanced Pharmacotherapy. × × × ×
Drug Safety. × Pharmacoeconomic
Applications. ×
Advanced toxicokinetics &
Drug poisoning × ×
الهيئة القومية لضمان جودة التعليم واالعتماد
Health Outcomes and
Health-Related Quality of
Life.
×
Oncology for Clinical
pharmacology. ×
Acute Care Cardiology ×
Clinical Immunology ×
Herbal use in therapy ×
ILO
Course
D1-
D2-
D3 D4 D5 D6
D7
D8-
D9-11
D12-13
D14 D15-16
Advanced Internal medicine × × × × ×
Pharmacology Updates I × × × × Pharmacology Updates II × × × ×
Advanced clinical pharmacokinetics and pharmacodynamics × × × × ×
Advanced Drug Discovery and development. ×
Biostatistics and data management in clinical trials ×
Advanced Neuropharmacology × × ×
Advanced Pharmacotherapy. × × ×
Drug Safety. ×
Pharmacoeconomic Applications. × × × ×
Advanced toxicokinetics & Drug poisoning ×
Health Outcomes and Health-Related Quality of Life. × × ×
Oncology for Clinical pharmacology. ×
Acute Care Cardiology ×
Clinical Immunology ×
Herbal use in therapy × × ×
الهيئة القومية لضمان جودة التعليم واالعتماد
ILO
Course
E1- E2 E3
E4 -E5 E6 -E7
Advanced Internal medicine × × × × Pharmacology Updates I × × × ×
Pharmacology Updates II ×
Advanced clinical pharmacokinetics and pharmacodynamics × × ×
Advanced Drug Discovery and development. × Biostatistics and data management in clinical trials ×
Advanced Neuropharmacology × × × × ×
Advanced Pharmacotherapy. × × × × × ×
Drug Safety. × Pharmacoeconomic Applications. × × × ×
Advanced toxicokinetics & Drug poisoning × × × × Health Outcomes and Health-Related Quality of Life. ×
Oncology for Clinical pharmacology. ×
Acute Care Cardiology ×
Clinical Immunology ×
Herbal use in therapy ×
5- Curriculum Structure and Contents:
5.1 Programme duration: 40 credit hours
5.2 Programme structure: …………………………………………………………..
C. Programme courses:
A. Obligatory:
Course Code Course Title Number No of Hours/Week
الهيئة القومية لضمان جودة التعليم واالعتماد
of Units Lectures Practical Clinical
051509060 Advanced Internal medicine 2 1 1
052409060 Oncology for Clinical
pharmacology. 2 1 1
050209060 Acute Care Cardiology 1 0.5 0.5
05060901 Pharmacology Updates I 3 2 1
05060902 Pharmacology Updates II 3 3
05060903 Advanced clinical
pharmacokinetics and
pharmacodynamics
2 1 1
05060904 Advanced Drug Discovery and
development. 3 2 1
05060905 Biostatistics and data
management in clinical trials 1 1
05060906 Advanced Neuropharmacology 2 1 1
05060907 Advanced Pharmacotherapy. 4 2 2
05060908 Drug Safety. 1 1
05060909 Pharmacoeconomic
Applications. 2 1 1
05060910 Advanced toxicokinetics &
Drug poisoning 3 2 1
05060911 Health Outcomes and Health-
Related Quality of Life. 1 1
05060912 Clinical Immunology 1 0.5 0.5
05060913 Herbal use in therapy 1 0.5 0.5
6- Curricular Contents:
Advanced Internal medicine
Code Course credit hours 2 Pre-requisites
051509060 Theoretical 1 Practical 1
Students taking this course examine how drugs work to attack various diseases including
neurological, nephrological, ENT, ophthalmic and dermatological diseases. They study commonly
prescribed medications, learning what they do, what side effects are possible and which drugs can't
be mixed. The class discusses reasons to use drugs to treat a condition even when the side effects
could be bad for the patient. The course also covers the problem of people developing immunity to a
drug or set of drugs.
Oncology for Clinical pharmacology.
Code Course credit hours 2 Pre-requisites
052409060 Theoretical 1 Practical 1
By the end of this course, the student is supposed to have the proper knowledge and understanding
about the pathogenesis and criteria of carcinogenesis, the common carcinogens. He should have
detailed information about anti-neoplastic agents, their mechanisms of action, therapeutic uses,
adverse drug reactions and contra-indications. Updated information about guidelines for treatment of
الهيئة القومية لضمان جودة التعليم واالعتماد
common neoplastic diseases will be discussed in this course
Acute Care Cardiology
Code Course credit hours 1 Pre-requisites
050209060 Theoretical 0.5 Practical 0.5
The Course Aims is to Gain advanced knowledge in optimizing use of medications for critically ill
cardiac patients and provide advanced clinical training in the areas of critical care pharmacotherapy to
develop independent problem-solving skills . This includes the establishment of a firm knowledge
base in cardiovascular pharmacology. The course will provide an integrated approach to critical
cardiovascular medicine and focus on applying scientific principles to direct patient care.
Pharmacology Updates -I
Code Course credit hours 1 Pre-requisites
05060901 Theoretical 3 Practical
The course is designed to provide graduate students with the skills of research proposal, Appraise the
role of cloning in drug discovery, Underline the potential applications of nanotechnology in
pharmacology, and to explain in depth the molecular level of drug action in the field of cellular
calcium regulation, oxidants/antioxidant balance and stem cell therapy
Pharmacology Updates II
Code Course credit hours 3 Pre-requisites
05060902 Theoretical 2 Clinical 1
This course is intended for the recognition of the different possible targets of drug action. It helps to
specify the level along any of the signaling cascade where a drug can possibly intervene to positively
or negatively achieve a beneficial therapeutic outcome. It further encourages selection between
similar group of drugs in light of their specificity and selectivity to a specified target. It will also
permit extrapolation of acquired data to new areas that can be targeted and open genuine avenues for
approaching such areas
Advanced clinical pharmacokinetics and pharmacodynamics
Code Course credit hours 2 Pre-requisites
05060903 Theoretical 1 Clinical 1
This course is intended to give advanced knowledge and application in clinical pharmacology.
Understanding the importance of drug monitoring. Discuss the role of dose adjustment for certain
drugs to improve patient treatment
الهيئة القومية لضمان جودة التعليم واالعتماد
Advanced Drug Discovery and development
Code Course credit hours 3 Pre-requisites
05060904 Theoretical 2 Clinical 1
Acquire advanced knowledge and apply recent techniques that help in exploring Drug discovery and
Development, in light of new and Novel criteria Targeted Drug Discovery and Development aiming
to reach the best Innovative Translational Strategies to Discover & Develop Drugs
Biostatistics and data management in clinical trials
Code Course credit hours 1 Pre-requisites
05060905 Theoretical 1 Clinical
By the end of this course The candidates will be able to Design a clinical trial, collect data, analyze
and interpret results, Use evidence based medicine.,Critically analyses papers regarding rationale,
cogen.cy, experimental design, analytical methodology, method of analysis, potential sources of bias,
confounding, conflict of interest, appropriateness of discussion, and validity of conclusions
Advanced Neuropharmacology
Code Course credit hours 2 Pre-requisites
05060906 Theoretical 1 Practical 1
Students taking this course examine how drugs work to attack various diseases affecting the nervous
system. They study commonly prescribed medications, learning what they do, what side effects are
possible and which drugs can't be mixed. The class discusses reasons to use drugs to treat a
condition even when the side effects could be bad for the patient. The course also covers the
problem of people developing immunity to a drug or set of drugs.
Advanced Pharmacotherapy
Code Course credit hours 4 Pre-requisites
05060907 Theoretical 2 Practical 2
This course aims to:
1. Enable students to recognize the factors that alter patient’s drug response.
2. Build up the ability of applying basic pharmacology knowledge on drugs use in common
medical diseases.
3. Provide students with the essentials of rules and the regulations that govern prescribing
medications.
4. Enable students to identify medication errors, adverse drug reactions, drug interactions and
over dosage.
5. Develop students’ skills in:
الهيئة القومية لضمان جودة التعليم واالعتماد
• Good communication with patients and families.
• Obtaining accurate drug history.
• Developing a sound drug therapy plan.
• Using information technology.
• Finding evidence-based information.
Drug Safety.
Code Course credit hours 1 Pre-requisites
05060908 Theoretical 1 Practical
This course tends toDevelop specialized knowledge and skills required to monitor and manage
clinical trials and to conduct drug safety and Pharmacovigilance activities including adverse reaction
reporting and preparing periodic safety update reports. Providing the foundation and practical
knowledge to formulate a sound clinical development plan; ensure clinical trial data is credible and
accurate; and that the rights, integrity and confidentiality of trial subjects are protected
Pharmacoeconomic Applications
Code Course credit hours 2 Pre-requisites
05060909 Theoretical 1 Practical 1
In general, the candidates will be able to use the decision analysis to model costs and their outcomes.
E.g. Markov model. Moreover, in view of retrospective databases, the candidate within a team will be
able to evaluate the cost and outcomes associated with Alexandria Faculty of Medicine Hospitals and
Pharmacy services.
An outcome for the pharmacology department is the address and the use of pharmacoeconomic
research in decision making regarding drug policy in major health problems
Advanced toxicokinetics & Drug poisoning
Code Course credit hours 3 Pre-requisites
05060910 Theoretical 2 Practical 1
The course aims to help the student to gain advanced knowledge and apply recent laboratory
techniques that helps in understanding the pharmacokinetic aspects of different therapeutic agents and
its implications in the field of drug poisoning and toxicology with exploration of recent guidelines in
their evaluation and management aiming to improve outcome and decrease in both drug related
morbidity and mortality.
الهيئة القومية لضمان جودة التعليم واالعتماد
Health Outcomes and Health-Related Quality of Life
Code Course credit hours 1 Pre-requisites
05060911 Theoretical 1 Practical
Course Aims to:
6. Identify the different patient-reported health outcomes and health-related quality of life
measures.
7. Emphasize on the importance of assessing health-related quality of life.
8. Appraise the reliability and validity of assessing health-related quality of life measures.
9. Distinguish common measures of health-related quality of life.
10. Develop students’ skills in assessment of :
• Health-related outcomes.
• Health-related quality of life.
• Quality-adjusted life-years.
• Health state preferences
Clinical Immunology
Code Course credit hours 1 Pre-requisites
05060912 Theoretical 0.5 Practical 0.5
This course aims to help student to Gain advanced knowledge and clinical skills in diagnosis and
treatment of immunological diseases. Distinguish the role of drug in manipulation of the immunologic
functions to suppress or stimulate cellular and humoural immunity. Recognize the
immunosuppressant drugs in organ transplantation and probable adverse drug reactions. Discuss the
genetic variation affecting drug metabolism and disposition and its reflection on dose modulation and
response to treatment
Herbal use in therapy
Code Course credit hours 1 Pre-requisites
05060913 Theoretical 0.5 Practical 0.5
By the end of this course the student will Gain advanced knowledge and criticize the highly
practiced herbs by Egyptian populations concerning the international published evidence based one.
Implement national guidelines for optimal use of herb-drug in common disease interventions
7- Programme Admission Requirements: According to the regulations of the credit hour bylaws of the Faculty of Medicine Alexandria University
(annex).
8- Regulations for Progression and Programme Completion: According to the regulations of the credit hour bylaws of the Faculty of Medicine Alexandria University
(annex).
الهيئة القومية لضمان جودة التعليم واالعتماد
10- Methods of student assessment:
Methods Intended Learning outcomes to be
assessed
1. Essay A1-41, B1-30
2. Case studies A1-41, B1-30, C1-14
3. Assignment A1-41, B1-30, C1-14, D1-16, E1-7.
4. Objective questions A1-41, B1-30, C1-14
5. OSCE/OSPE A1-41, B1-30, C1-14, D1-16, E1-7.
11- Methods of programme evaluation:
Evaluator Tool Sample
1. Questionnaires
2. Alumni
3. Stakeholders (Employers)
4. External Evaluator (s)
5. Others:
Programme Director: Prof. Dr. Samya Mohamed Ali Signature:
Programme coordinator: Prof Dr. Mohamed Gamal El-din Signature:
Date: / /
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 051509060 Course Name: Advanced Internal Medicine
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Students taking this course examine how drugs work to attack various diseases including
neurological, nephrological, ENT, ophthalmic and dermatological diseases. They study commonly
prescribed medications, learning what they do, what side effects are possible and which drugs can't be
mixed. The class discusses reasons to use drugs to treat a condition even when the side effects could
be bad for the patient. The course also covers the problem of people developing immunity to a drug or
set of drugs.
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge and
Understanding
A1. Discuss the pharmacology and
possible effects of a drug and
integrate other disciplines with
clinical pharmacology.
A2. Review the pharmacodynamic
and pharmacokinetic concepts that
will help in understanding basic
drug actions.
A4. List the available targets of
drug action
A5. Describe the characteristic
specification of each target
a1. Discuss the pharmacology and
possible effects of a drug from an
understanding of its mechanism of action
a2. Perform complex medication reviews
and provide advice on judicious
prescribing
a3. Provide in-depth advice on prescribing
in special patient groups, including older
people, children, pregnant and nursing
mothers, and patients with renal or hepatic
disease
a4. Describe clinically important
genotypes that produce atypical patient
responses to medications
a5. Discuss and recognise potential drug
interactions
1 1
A6. Classify each target to
different subcategories and
superfamilies that have been so far
enrolled
A7. Identify linking signaling
cascade of each target and
potential sites where a drug can
possibly intervene starting at cell
surface down to nuclear
modulation and gene expression or
repression
a6. Provide advice on therapeutic drug
monitoring, including dose discussion
calculations
a7. Design and conduct clinical trials
a8. Perform drug utilisation evaluations
a9. Assess adverse drug reactions and
determine causality, and have awareness
of national and international
pharmacovigilance systems
a 10. Diagnose and manage adverse drug
reactions
a 11. Extract and critically evaluate drug
information
a 12. Interpret and develop evidence-
based prescribing guidelines
B. Intellectual skills
B1. Evaluate and provide drug
information
B2. Formulate evidence-based
treatment strategies for important
emergency situations
B3. Correlate the action of drugs
on their targets to their abilities to
achieve a specific therapeutic
outcome
B4. Predict the possibility of
maximizing drug benefits and
minimizing adverse effects based
on the acquired knowledge linked
to the studied signaling cascades
b1. Describe drug safety, including
assessment and management of adverse
drug reactions (adrs),
adverse drug events (ades) and drug error
b.2 Diagnose and manage drug
interactions
b.3 Interpret drug concentrations and give
advice on dose individualisation
b.4 Access, evaluate and provide drug
information
C.Professional and
Practical Skills
C1. Add to the practice of the
specialty and research through
creativity & innovation
C2. Assessment of drug regimens
in different clinical situations in
the hospitalized patients
C3. Criticize specific drugs in
specific situations
c.1 Develop drug policies and actively
contribute to drug-related committee
activities
c.2 Describe, practice and advise on
quality use of medicines (qum)
c.3 Assess and manage issues related to
compliance/adherence/concordance
c.4 Critically review medications and
prescribe rationally
D. General Skills
D1. Hold skills to critically
evaluate evidence presented by
publications
D2. Acquiring new communication
skills in designing and delivering
talks and lectures
D3. Train in team working
D4. Retreive methods for data
search and information analysis
D5. Recognize tools for critique
and peer reviewing
d1. Assess a possible drug interaction in
terms of causality, and classify according
to type
d2. Interpret laboratory data
d3. Write a complete, correct and legal
prescription
d4. Perform complex medication reviews
and provide
advice on judicious prescribing
d5. Promote better prescribing
E. Attitudes
and ethical
behavior
E1. Apply regulations and ethics
that govern physicians in
promotion and detailing of drugs.
E4. Manage confusion of roles in
academic medical centers and
problems with duplicative,
interactive, or conflicting drug
treatment plans
E5. Integrate with other members
of medical team to provide the
patients the appropriate medical
care
E7. Show respect to professors,
colleagues, other members of
medical team and to patients
e1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs used in common
internal medicine cases.
e4. Manage confusion of roles in
academic medical centers and problems
with duplicative, interactive, or conflicting
drug treatment plans
e5. Integrate with other members of
medical team to provide the diabetic,
endocrinal and renal patients the
appropriate medical care
e7. Show respect to professors,
colleagues during lectures and oral
presentations, other members of medical
team and to patients during clinical
practice
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
Neuropsychiatry: Epilepsy, Transient
Ischemic Attacks, cerebral infarction
&ischemic Stroke, Parkinsonism,
Peripheral Neuropathies, Meningitis,
Alzheimer disease and other dementias,
Anxiety and depression, Schizophrenia,
obsessive-compulsive disorders &
personality disorders.
✓ ✓ ✓
Nephrology: Acute glomerulonephritis,
Chronic glomerulonephritis, Nephrotic
syndrome, Chronic renal failure
✓ ✓
Dermatology: Topical corticosteroids,
Psoriasis, Vitiligo, Acne valgaris,
Infections and the skin
✓ ✓
Ophthalmology: Cataract, Glaucoma,
Infective conjunctivitis
✓ ✓ ✓
ENT: Chronic rhinosinusitis ✓ ✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam 30 %
Others %
✓ ✓
✓
✓
List of Textbooks and References
Lecture Notes
✓
Course Text Books
Principles of clinical pharmacology 3rd edition
By: Arthur J. Atkinson
Suggested Extra Reading
Journals and Periodicals, others
• Ann. Rev. Pharmacol
Course Instructor
Name: Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060901 Course Name: Pharmacology Update I
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
1.To provide graduate students with the skills of research proposal
2.Appraise the role of cloning in drug discovery
3.Underline the potential applications of nanotechnology in pharmacology
4.Explain in depth the molecular level of drug actiion in the field of cellular calcium regulation,
oxidants/antioxidant balance and stem cell therapy
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A1. Discuss the pharmacology and
possible effects of a drug and integrate
other disciplines with clinical
pharmacology
A2. Review the pharmacodynamic and
pharmacokinetic concepts that will help
in understanding basic drug actions.
A3. Recognize the essential basics of
pharmacological research
a1.Define different animal models for
pharmacologic studies
a2.Identify the role of transgenic mice in
pharmacological research
a3.State the role of cloning in drug
discovery
a4.Outline the molecular basis of drug
action at the level of cellular calcium
regulation, oxidant and antioxidant balance
a5.Identify the role of stem cell in therapy
1 2
B. Intellectual
skills
B1. Evaluate and provide drug
information
B2. Formulate evidence-based
treatment strategies for important
emergency situations.
B3. Correlate the action of drugs on
their targets to their abilities to achieve
a specific therapeutic outcome
B4. Predict the possibility of
maximizing drug benefits and
minimizing adverse effects based on
the acquired knowledge linked to the
studied signaling cascade
b1.Describe different approaches in stem
cell therapy
b2.Apply the basic knowledge of cellular
calcium regulation as targets of drug action
b3.Apply basic knowledge in
nanotechnology in therapeutics and drug
delivery
b4.Compare animal studies and clinical
trials and how to extrapolate results of
animal studies to human pharmacology
b5.Illustrate approaches of stem cell therapy
C.
Professional
and Practical
Skills
C1. Add to the practice of the specialty
and research through creativity &
innovation
C11. Apply recent advances in
methodology and laboratory
technology in drug research and
clinical investigations
c1. Select appropriate animal models for
different pharmacological experiments
c2.Evaluate the use of transgenic mice in
pharmacological research
c3.Recommend new applications of cloning
in drug discovery
D. General
Skills
D1. Hold skills to critically evaluate
evidence presented by publications.
D2. Acquiring new communication
skills in designing and delivering talks
and lectures
D3. Train in team working
D7 Communicate and collaborate
within a team Application level.
d1.Perform practice-based improvement
activities using a systematic methodology
d2.Locate, appraise and assimilate evidence
from scientific studies related to health
problems
d3.Use information technology to manage
information, access on-line medical
information and support self learning.
Attitudes and
ethical
behavior
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs.
e1. Apply regulations and ethics that govern
physicians in promotion and detailing of
drugs used in common internal medicine
cases.
E4. Manage confusion of roles in
academic medical centers and problems
with duplicative, interactive, or
conflicting drug treatment plans
E5. Integrate with other members of
medical team to provide the patients
the appropriate medical care
E7. Show respect to professors,
colleagues, other members of medical
team and to patients
e2. Manage confusion of roles in academic
medical centers and problems with
duplicative, interactive, or conflicting drug
treatment plans
e3. Integrate with other members of medical
team to provide the diabetic, endocrinal and
renal patients the appropriate medical care
e4. Show respect to professors, colleagues
during lectures and oral presentations, other
members of medical team and to patients
during clinical practice
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small group
discussion
Others
1. Differences between animal and
human pharmacology
✓ ✓
2. Animal models of pharmacological
studies
✓ ✓
3. Transgenic mice ✓
4. Role of cloning in crug discovery ✓ ✓
5. Basis and pharmacological
application of nanotechnology
✓ ✓
6. Regulation and dysregulatuion of
celluylar calcium
✓ ✓
7. Oxidative stress and anytooxidants ✓ ✓
8. Stem cell therapy ✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam 30 %
Others %
List of Textbooks and References Lecture Notes
✓
Course Text
Books
• Katzung Basic and Clinical Pharmacology
• Goodman and Gilmen’s the Pharmacological Basis of Therapeutics
• Offemanns, Rosenthal (eds.) Encyclopedia of molecular pharmacology
• Molecular pharmacology: from DNA to drug discovery
• Frontiers in nanobiomedical research: vol. 3: Highlights in Nanomedicine,
Nanotechnology and Pharmacology.
Suggested Extra
Reading
--
Journals and
Periodicals,
others
• British journal of Pharmacology
• Pharmacological review
• Stem cell research
• Cloning and transgenesis
• Drug Discovery Today: Disease Models
Course Instructor
Name: Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
✓ ✓
✓
✓
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060901 Course Name: Pharmacology Update II
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims This course is intended for the recognition of the different possible targets of drug action. It helps to specify the level along any of the signaling cascade where a drug can possibly intervene to positively or negatively achieve a beneficial therapeutic outcome. It further encourages selection between similar group of drugs in light of their specificity and selectivity to a specified target. It will also permit extrapolation of acquired data to new areas that can be targeted and open genuine avenues for approaching such areas.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A4. List the available targets of drug action
A5. Describe the characteristic
specification of each target
A6. Classify each target to different
subcategories and superfamilies that have
been so far enrolled
A7. Identify linking signaling cascade of
each target and potential sites where a
drug can possibly intervene starting at cell
surface down to nuclear modulation and
gene expression or repression
A8. Describe the final outcome of
modulating the different selected targets
A1.Classify drug transporters
A2.Enumerate different types of channels
A3.State different cell surface receptors
A4.Explain different modalities of
transcription regulation
A5.Locate the different phases of cell cycle
A6. Compare active and facilitated
transporters
A7. Classify active trasporters
A8. Describe different checkpoints
A9. Identify the characteristic specification of
each target
3
in terms of survival and death
A10. Identify linking signaling cascade of each
target and potential sites where a drug can
possibly intervene starting at cell surface down
to nuclear modulation and gene expression or
repression
B. Intellectual
skills
B3. Correlate the action of drugs on their
targets to their abilities to achieve a
specific therapeutic outcome
B4. Predict the possibility of maximizing
drug benefits and minimizing adverse
effects based on the acquired knowledge
linked to the studied signaling cascades
B5. Analyze areas of signaling cross talk
where a single drug can act instead of
several drugs
B6. Allocate potential signaling molecules
that could be a target for new drug
development
B7. Suggest a new targets where drugs can
be used in regenerative therapy versus
those that can be eliminate undesirable
cell lines
B1. Demonestrate how targeting the canonical
versus non-canonical pathway of receptor
signaling vary in drug action
B2.Utelize the varied signaling pathway to
explain the concept of biased agonists and
biased modulators
B3.Detect the importance of cell surface
receptors cross talk in the action of growth
factors and cytokines
B4. Identify potential signaling molecules that
could be a target for new drug development
B5. Review a new targets where drugs can be
used in regenerative therapy versus those that
can be eliminate undesirable cell lines
C.
Professional
and Practical
Skills
none
D. General
Skills
D2. Acquiring new communication skills in
designing and delivering talks and lectures
D1.Develop communication skills in
presenting assignments
D2.Appraise good behavioral conduct and
D3. Train in team working
D4. Retrieve methods for data search and
information analysis
D5. Recognize tools for critique and peer
reviewing
reject mal performance
D3.Construct checklist to assess scientific
and behavior conduct of colleagues.
Attitudes and ethical behavior
E7. Show respect to professors,
colleagues, other members of medical
team and to patients
E1. Show respect to professors, colleagues
during lectures and oral presentations
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Targeting drugs to different biological molecules
✓ ✓
2. Drugs acting on transporter proteins or interacting with biological barriers
✓
3. Drugs acting on ion channels
4. Drugs acting through cell surface receptors
✓ ✓
5. Drugs acting as or activating transcription factors
✓ ✓
6. Drugs acting on nuclear receptors ✓ ✓ ✓
7. Epigenetic therapy and gene therapy ✓ ✓
8. Drugs promoting cell survival and drugs inducing apoptosis
✓ ✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam
Others (ASSIGNMENT) 30%
List of Textbooks and References
Lecture Notes
✓
Course Text Books
1. Molecular Pharmacology; from DNA to Drug Discovery By; Dickenson, Freeman, Mills, Sivasubramaniam, Thode
2. Molecular Cell Biology By Lodish, Berk, Scott, Krieger, Darnell, Kaiser, Zipursky, Matsudaira
• .
Suggested Extra Reading
Albert's Molecular biology of the cell
Journals and Periodicals, others
• British journal of Pharmacology
• Pharmacological review
• Stem cell research
• Cloning and transgenesis
• Drug Discovery Today: Disease Models
Course Instructor
Name: Signature:
✓ ✓
✓
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060903 Course Name: Advanced clinical
pharmacokinetics and pharmacodynamics
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours 2 Theoretical Clinical/Practical
Course Aims
This course is intended to give advanced knowledge and application in clinical pharmacology.
Understanding the importance of drug monitoring. Discuss the role of dose adjustment for certain drugs
to improve patient treatment
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A1. Discuss the pharmacology and
possible effects of a drug and integrate
other disciplines with clinical
pharmacology.
A2. Review the pharmacodynamic and
pharmacokinetic concepts that will help
in understanding basic drug actions.
A9. Recognize the importance of dose
adjustment of some antimicrobial drugs
A10. Evaluate the importance of drug
monitoring of certain drugs
A11. Assess the plasma level of certain
immunosuppressant drugs
a1.calcultae volume of distribution, t-half,
elimination rate constant, time to steady
state of aminoglycosides, vancomycin, anti-
epileptic drugs, immunosuppressant drugs
and drugs with narrow therapeutic index
a2.predict the dose of these drugs in
different diseases that affect drug kinetics
1 1
A12. Discuss the pharmacokinetics of
drugs with narrow therapeutic index
B. Intellectual
skills
B8. Design the therapeutic regimen of
drugs depending on the desired steady
state plasma level
b1. specify the needed dose and the dose
interval in renal or hepatic impairment
C.
Professional
and Practical
Skills
C2. Assessment of drug regimens in
different clinical situations in the
hospitalized patients
c1. recommend the dose regimen to
improve the use of drugs in critical disease
situations
D. General
Skills
D2. Acquiring new communication
skills in designing and delivering talks
and lectures
D3. Train in team working
D4. Retrieve methods for data search
and information analysis
D5. Recognize tools for critique and
peer reviewing
D14. Participate in experimental
studies
d1.develop communication skills in
presenting assignments
d2.appraise good behavioral conduct and
reject mal performance
d3.construct checklist to assess scientific
and behavior conduct of colleagues.
d4. participate in experimental studies to
assess drug kinetics and dynamics
Attitudes and
ethical
behavior
E5. Integrate with other members of
medical team to provide the patients
the appropriate medical care
E6. Apply regulations and ethics during
laboratory work on experimental
animals
E7. Show respect to professors,
colleagues, other members of medical
team and to patients
e1. integrate with other members of medical
team to provide the patients the appropriate
medical care, applying the studied criteria
regarding pharmacokinetic and dynamic
properties of drugs
e2. apply regulations and ethics during
laboratory work
e3. show respect to professors, colleagues
during lectures and oral presentations
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
Application of pharmacokinetic
principles in clinical use of:
1. Antibiotics
✓ ✓ ✓
2. Cardiovascular agents ✓ ✓ ✓
3. Anticonvulsants ✓ ✓
4. Immunosuppressants ✓ ✓ ✓
5. Other drugs ✓ ✓ ✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam
Others (ASSIGNMENT) 30%
✓ ✓
✓
List of Textbooks and References
Lecture Notes
✓
Course Text Books
Principles of clinical pharmacology
Applied therapeutics the clinical use of
drugs
• .
Suggested Extra Reading
Clinical pharmacology
Journals and Periodicals, others
• J clin ther
• J clin Pharm
• Pharmacotherapy
Course Instructor
Name: Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060904 Course Name: Advanced Drug Discovery and development
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Acquire advanced knowledge and apply recent techniques that help in exploring Drug discovery and
Development, in light of new and Novel criteria Targeted Drug Discovery and Development aiming
to reach the best Innovative Translational Strategies to Discover & Develop Drugs.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A13. Distinguish Phase I Clinical
Studies
a.1 Describe Essential Research and Study
Skills
a.2 Identify Modern Pre- to Post-Clinical
Research
a.3 Discuss Registration of Drugs and
Pharmaceutical Products
a.4 Discuss Advanced Drug Design.
a.14 Describe Pharmacokinetic and
Pharmacodynamic Considerations in
the Development of Biotechnology
Products and Large Molecules
a.5 Identify Biochemical and Molecular
Methods in Toxicology
a.6 Discuss Cell Culture Techniques
a.7 Identify Molecular Techniques
a.8 Distinguish Immunochemical Techniques
A15 Distinguish Design of Clinical
Development Programs
a.9 Discuss Cell Signalling Pathways for
Drug Discovery
a.10 Point Discovery Approaches for
Neglected Tropical Diseases
a.11 Summarize Drug Repurposing,
Repositioning and Orphan Drugs
a.12 Point GPCR based Drug Design
a.13 Identify Innovative Translational
Strategies to Discover & Develop Drugs
1 2
a.14 Summarize Novel Screening
Methodologies for Drug Discovery
a.15 Point Novel Therapeutic Targets using
Chemical Biology
a.16 Recognize Pre-Clinical Drug
Development
a.17 Distinguish Success in Drug Discovery
a.18 Identify Targetting Protein-Protein
Interactions
a.19 Describe Targeted Drug Discovery and
Development.
a.16 Distinguish Role of the
Administration (e.g. FDA) in Guiding
Drug Development
a.20 Discuss Planning Clinical Trial program
(use of preclinical and Phase I data)
a.21 Point Study types and designs
a.22 Discuss Study conduct
a.23 Summarize Quality control and quality
assurance
a.24 Summarize Adverse Events (definitions,
collection, reporting, assessment, coding)
a.25 Identify Interpretation of study design,
analysis and results.
a.17Distinguish clinical applications
of Drug Discovery and development
a.26 Interpret Clinical application in drug
research center
a.27 Outline Project in drug development
a.28 Distinguish Clinical training in
pharmaceutical companies.
B. Intellectual
skills
B9. Design Phase I Clinical Studies
b1. Sort Essential Research and Study Skills
b2. Transform Modern Pre- to Post-Clinical
Research
b3. Distinguish Registration of Drugs and
Pharmaceutical Products
b4. Contrast Advanced Drug Design.
B10. Apply Pharmacokinetic and
Pharmacodynamic Considerations in
the Development of Biotechnology
Products and Large Molecules
b5. Compose Biochemical and Molecular
Methods in Toxicology
b6. Distinguish Cell Culture Techniques
b7. Distinguish Molecular Techniques
b8. Distinguish Immunochemical
Techniques.
B11. Construct Design
of Clinical Development
Programs
b9. Appraise Cell Signalling Pathways for
Drug Discovery
b10. Contrast Discovery Approaches for
Neglected Tropical Diseases
b11. Build Drug Repurposing, Repositioning
and Orphan Drugs
b12. Appraise GPCR based Drug Design
b13. Compose Innovative Translational
Strategies to Discover & Develop Drugs
b14. Analyze Novel Screening
Methodologies for Drug Discovery
b15. Analyze Novel Therapeutic Targets
using Chemical Biology
b16. Distinguish Pre-Clinical Drug
Development
b17. Contrast Success in Drug Discovery
b18. Distinguish Targetting Protein-Protein
Interactions
b19. Relate Targeted Drug Discovery and
Development.
B12. Construct Role of
the Administration (e.g.
FDA) in Guiding Drug
Development
b20. Operate Planning Clinical Trial program
(use of preclinical and Phase I data)
b21. Contrast Study types and designs
b22. Apply Documentation (protocols,
reports, source documents, case report
forms, study master file, investigator’s
brochure).
b23. compose Study conduct
b24. Analyze Quality control and quality
assurance
b25. Appraise Adverse Events (definitions,
collection, reporting, assessment,
coding)
b26. Interpretation of study design, analysis
and results.
b.13 Criticize clinical applications of
Drug Discovery and development
b27. Appraise Clinical application in drug
research center
b28. Criticize Project in drug development
b29. Compose Clinical training in
pharmaceutical companies.
C.Professional
and Practical
Skills
C3. Criticize specific drugs in
specific situations
C1. Apply update in Personalized Medicine, ,
C2. Appraise update pharmacologic knowledge
to select the best drug for a particular Elderly
and Pediatric Populations
C3. Solve problems of Orphan Drugs,
Comparative Effectiveness, Combination
Treatments, Transparency...etc.
D. General
Skills
d1. Hold skills of class discussion
and critical evaluation of
evidence presented by
publications or industry.
d1. Demonstrate competent presentation and
knowledge in class and respect questions
and inquires from colleagues and
professors.
d2. Prove efficient skills in searching databases
and evidence-based guidelines.
d3. Display good time-management during talk,
case presentation and discussion.
Attitudes and
ethical
behavior
E7. Show respect to professors,
colleagues, other members of medical
team and to patients.
e1. Show respect to professors, colleagues,
during lectures and discussion
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Essential Research and Study
Skills
✓ ✓
2. Modern Pre- to Post-Clinical
Research
✓ ✓
3. Registration of Drugs and
Pharmaceutical Products
✓ ✓
4. Advanced Drug Design ✓ ✓
5. Biochemical and Molecular
Methods in Toxicology
✓ ✓
▪ Cell Culture Techniques ✓ ✓
▪ Molecular Techniques ✓
▪ Immunochemical
Techniques
✓ ✓
6. Cell Signalling Pathways for
Drug Discovery
✓ ✓
7. Discovery Approaches for
Neglected Tropical Diseases
✓ ✓
8. Drug Repurposing,
Repositioning and Orphan
Drugs
✓
9. GPCR based Drug Design ✓
10. Innovative Translational
Strategies to Discover &
Develop Drugs
✓
11. Novel Screening Methodologies
for Drug Discovery
✓
12. Novel Therapeutic Targets using
Chemical Biology
✓
13. Pre-Clinical Drug Development ✓
14. Success in Drug Discovery ✓
15. Targetting Protein-Protein
Interaction.
✓
16. Targeted Drug Discovery and
Development
✓ ✓
17. Planning Clinical Trial program
(use of preclinical and Phase I
data)
✓ ✓
18. Study types and designs ✓ ✓
19. Documentation (protocols,
reports, source documents, case
report forms, study master file,
investigator’s brochure).
✓ ✓
20. Study conduct ✓ ✓
21. Quality control and quality
assurance
✓ ✓
22. Adverse Events (definitions,
collection, reporting,
assessment, coding)
✓ ✓
23. Interpretation of study design,
analysis and results.
✓ ✓
Practical:
1. Clinical application in drug
research center
✓
2. Project in drug development ✓
3. Clinical training in
pharmaceutical companies.
✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 40 %
End of term 60 %
Distribution of Marks
Written Exam 60 %
Practical/Clinical Exam 40 %
Others (attendance/Assignment) %
List of Textbooks and References
Lecture Notes
Manuscripts of Assignment Topics prepared by
candidates and revised by supervising professors.
Course Text Books
Drug Discovery and Development
UNDERSTANDING THE R&D PROCESS (by
innovation.org)
Biopharmaceutical Research &
Development: The Process Behind New
Medicines (www.phrma.org)
Suggested Extra Reading
1) Katzung basic and clinical Pharmacology
2) Lippincot' s Pharmacology review
3) Goodman and Gillman Basic Pharmacology.
Journals and Periodicals, others
Review articles on pubmed and Medscape on Drug
discovery and Development
for more information: www.phrma.org
Course Instructor
Name: Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
✓ ✓
✓
✓ ✓
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060905 Course Name: Biostatistics and data
management in clinical trials
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
The candidates will be able to
Design a clinical trial, collect data, analyze and interpret results.
Use evidence based medicine
Critically analyses papers regarding rationale, cogency, experimental design, analytical methodology,
method of analysis, potential sources of bias, confounding, conflict of interest, appropriateness of
discussion, and validity of conclusions.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program matrix) Course ILOs
A. Knowledge
and
Understanding
A18. Design a clinical trial, collect
data, analyze and interpret results.
al- Identify the rules regulating clinical
trials
a2- Define hypothesis testing, The null
hypothesis, Type I and II errors,
significance and power
a3- Discuss Risk factors, confounding
variables
a4- Enumerate types of data
a5-Explain Variations in biometry in
population, in disease
a6- Discuss Types of analysis
a7- Outline study design
1
a8-.Define evidence based medicine
a9- Assess violations, withdrawals, errors,
bias
a10- Discuss Sources of bias
a 11- Explain Statistical principles and
issues in report writing: data manipulation,
transposition, merging
B. Intellectual
skills
B14. Assess the presence or absence
of significant difference
between different groups of the
clinical trial, using the
appropriate statistical test
bl- Apply the studied statistical principles to
test the null hypothesis
b2- Compare Paired and non-paired tests,
parametric and non-parametric tests
B15 - Critically analyses papers
b3- Critique six studies regarding rationale,
cogency, experimental design, analytical
methodology, method of analysis, potential
sources of bias, confounding, conflict of
interest, appropriateness of discussion,
validity of conclusions
b4- Design/ practice a clinical trial to
compare new drugs with standard therapy
C.
Professional
and Practical
Skills
C4. Use computer programs to assess
the level of significance between
different groups of a study
c1. Use computer programs to assess the
level of significance between different
groups of a study
c2. Interpret graphs to get statistical
informations
c3. Acquire personal/professional skills
(e.g. functioning within an organization)
D. General
Skills
D1 Hold skills to critically
evaluate evidence presented by
publications
d1. Communicate and share ideas with
professors to Use the computer statistical
programs
d2. Communicate and collaborate within a
team Application level
d3. Participate in Conceptualization level
Attitudes and
ethical
behavior
E7. Show respect to professors,
colleagues, other members of medical
team and to patients.
e1. Show respect to professors, colleagues,
during lectures and discussion
Course Content (Units/Topics)
Teaching/Leang Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Trial design, hypothesis testing,
power
• Pre-trial decisions and specification
• Risk factors, confounding variables
• The null hypothesis, Type I and II
errors, significance, power
✓ ✓
2. Measurement and types of data
• Standardization
• Variations in biometry in
population, in disease
✓ ✓
3. Data collection and management
• Creation, maintenance and security
of databases, software validation and
archiving
• Data management from clinical
trials: corrections verifications and
extraction
• Within-trial decisions, data
management, extraction and
manipulation
✓ ✓
4. Types of analysis
• Analysis of efficacy end-points and
of safety
• Paired and non-paired tests,
parametric and non-parametric tests,
confidence limits
• Handling of rating and visual
analogue scales, patient diaries and
laboratory values
✓ ✓
5. 5. Interpretation of study design,
analysis and results
• Assessment of violations,
withdrawals, errors, bias
• Statistical principles and issues in
report writing: data manipulation,
transposition, merging
• Clinical interpretation of trial
• Final report writing and formatting for
registration dossier and publications
✓ ✓
6. What is evidence based medicine
and Causation
Searching the medical literature
Study design and strength of evidence
✓ ✓
7. Instruments and measurements
strength and validity
Sources of bias
Hypothesis testing
Types of error and number needed to
treat
✓ ✓
8. Method of analysis, potential sources
of bias, confounding, conflict of
interest, appropriateness of discussion,
validity of conclusions.
✓ ✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 100 %
Practical/Clinical Exam
Others %
✓
✓
✓ ✓
List of Textbooks and References
Lecture Notes
✓
Course Text Books
• Karen L.Rasacati (2014), Essentials of
Pharmacoeconomics, 2nd ed., Wolters
Kluwer, Lippincott, William & Wilkins
Austin, Texas.
• Copeland, R. A., and Anderson, P. S.
(2002), in Textbook of Drug Design and
Discovery, 3rd ed., P. Krogsgaard-
Larsen, T. Liljefors, and U. Madsen, eds.,
Taylor and Francis, New York,
Suggested Extra Reading
International Society for Pharmacoeconomics
and Outcomes Research membership
Journals and Periodicals, others
Publications of ISPOR= International Society
for Pharmacoeconomics and Outcome
research)
Egyptian Guidelines and reports for Reporting
Pharmacoeconomic Evaluations
Course Instructor
Name: Prof. Inas Darwish Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060906 Course Name: Advanced Neuropharmacology
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours 2 Theoretical Clinical/Practical
Course Aims
Students taking this course examine how drugs work to attack various diseases affecting the nervous
system. They study commonly prescribed medications, learning what they do, what side effects are
possible and which drugs can't be mixed. The class discusses reasons to use drugs to treat a condition
even when the side effects could be bad for the patient. The course also covers the problem of people
developing immunity to a drug or set of drugs.
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A1. Discuss the pharmacology and
possible effects of a drug and integrate
other disciplines with clinical
pharmacology.
A2. Review the pharmacodynamic and
pharmacokinetic concepts that will help
in understanding basic drug actions
A9. Recognize the importance of dose
adjustment of some antimicrobial drugs
A10. Evaluate the importance of drug
monitoring of certain drugs
A11. Assess the plasma level of certain
immunosuppressant drugs
A12. Discuss the pharmacokinetics of
drugs with narrow therapeutic index
a1. Discuss the pharmacology and possible
effects of a drug from an understanding of
its mechanism of action
a2. Perform complex medication reviews
and provide advice on judicious prescribing
a3. Provide in-depth advice on prescribing
in special patient groups, including older
people, children, pregnant and
nursing mothers, and patients with renal or
hepatic disease
a4. Describe clinically important genotypes
that produce atypical patient responses to
medications
a5. Discuss and recognise potential drug
interactions
a6. Provide advice on therapeutic drug
monitoring, including dose discussion
calculations
1 1
a7. Design and conduct clinical trials
a8. Perform drug utilisation evaluations
a9. Assess adverse drug reactions and
determine causality, and have awareness of
national and international
pharmacovigilance systems
a 10. Diagnose and manage adverse drug
reactions
a 11. extract and critically evaluate drug
information
a 12. interpret and develop evidence-based
prescribing guidelines
B. Intellectual
skills
B1. Evaluate and provide drug
information
B3. Correlate the action of drugs on
their targets to their abilities to achieve
a specific therapeutic outcome
B4. Predict the possibility of
maximizing drug benefits and
minimizing adverse effects based on
the acquired knowledge linked to the
studied signaling cascades
b1. Describe drug safety, including
assessment and management of adverse
drug reactions (adrs),
adverse drug events (ades) and drug error
b.2 Diagnose and manage drug interactions
b.3 Interpret drug concentrations and give
advice on dose individualisation
b.4 Access, evaluate and provide drug
information
C.Professional
and Practical
Skills
C1. Add to the practice of the specialty
and research through creativity &
innovation
C2. Assessment of drug regimens in
different clinical situations in the
hospitalized patients
C3. Criticize specific drugs in specific
situations
c.1 Develop drug policies and actively
contribute to drug-related committee
activities
c.2 Describe, practice and advise on quality
use of medicines (QUM)
c.3 Assess and manage issues related to
compliance/adherence/concordance
c.4 Critically review medications and
prescribe rationally
D. General
Skills
D1. Hold skills to critically evaluate
evidence presented by publications
D2. Acquiring new communication
skills in designing and delivering talks
and lectures
D3. Train in team working
d1. Assess a possible drug interaction in
terms of
causality, and classify according to type
d2. Interpret laboratory data
d3. Write a complete, correct and legal
prescription
d4. Perform complex medication reviews
and provide
advice on judicious prescribing
d5. Promote better prescribing
Attitudes and
ethical
behavior
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs.
E2. Obtain consent that is truly
informed
E3. Manage special challenges of
performing clinical research in
vulnerable populations
E4. Manage confusion of roles in
academic medical centers and problems
with duplicative, interactive, or
conflicting drug treatment plans
E5. Integrate with other members of
medical team to provide the patients
the appropriate medical care
E7. Show respect to professors,
colleagues, other members of medical
team and to patients.
e1 Apply regulations and ethics that govern
physicians in promotion and detailing of
neurological ddrugs.
e2. Obtain consent that is truly informed
before patient participation in any trials
e3. Manage special challenges of
performing clinical research in vulnerable
populations
e4. Manage confusion of roles in academic
medical centers and problems with
duplicative, interactive, or conflicting
neurological drug treatment plans
e5. Integrate with other members of medical
team to provide the patients the appropriate
medical care for common neurological
diseases
e7. Show respect to professors, colleagues,
other members of medical team and to
patients.in teaching and medical practice
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
Basic Principles of
Neuropharmacology, Cellular Basis of
Communication, Synaptic
Transmission, Pain, Neuroinflammation
✓ ✓ ✓
Sleep and Arousal, Higher Cognitive
Function and Behavioral Control, Mood
and Emotion, Reinforcement and
Addictive Disorders, Schizophrenia and
Bipolar Disorder, Neurodegeneration,
Seizure Disorders, Stroke and Migraine.
✓ ✓
Atypical Neurotransmitters, Autonomic
Nervous System, Neural and
Neuroendocrine Control of the Internal
Milieu
✓ ✓ ✓
Signal Transduction in the
Brain, Excitatory and Inhibitory
Amino Acids, Widely Projecting
Systems: Monoamines,
Acetylcholine, and Orexin,
Neuropeptides
✓ ✓ ✓
Please check (✓) the appropriate method
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam 30 %
Others %
✓ ✓
✓
✓
List of Textbooks and References
Lecture Notes
✓
Course Text Books
Molecular Neuropharmacology: A Foundation
for Clinical Neuroscience, 3e
Eric J. Nestler, MD, PhD, Steven E. Hyman,
MD, David M. Holtzman, MD, Robert C.
Malenka, MD, PhD
Suggested Extra Reading
Journals and Periodicals, others
• Ann. Rev. Pharmacol
Course Instructor
Name: Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060907 Course Name: Pharmacotherapy (Rational use of drugs)
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours: 4 Theoretical Clinical/Practical
Course Aims to:
1. Enable students to recognize the factors that alter patient’s drug response.
2. Build up the ability of applying basic pharmacology knowledge on drugs use in common
medical diseases.
3. Provide students with the essentials of rules and the regulations that govern prescribing
medications.
4. Enable students to identify medication errors, adverse drug reactions, drug interactions and over
dosage.
5. Develop students’ skills in:
• Good communication with patients and families.
• Obtaining accurate drug history.
• Developing a sound drug therapy plan.
• Using information technology.
• Finding evidence-based information.
Intended Learning Outcomes (ILOs)
Program ILO Course ILOs
A. Knowledge
and
Understanding
A1. Discuss the pharmacology and
possible effects of a drug and
integrate other disciplines with
clinical pharmacology.
A2. Review the pharmacodynamic
and pharmacokinetic concepts that
A1.Identify principles of rational drug use.
A2.Discuss clinical use of antimicrobial drugs.
A3.Outline management of rheumatoid Arthritis.
A4. Explain the clinical use of antiepileptic drugs.
A5. State lines of pain management.
A6. Describe the mechanism of action and drug
interactions related to the management of
common medical diseases.
2 2
will help in understanding basic drug
actions.
A19. Review recent guidelines in
management of common diseases.
B. Intellectual
skills
B1. Evaluate and provide drug
information
B2. Formulate evidence-based
treatment strategies for important
emergency situations
B16. Formulate evidence-based
treatment strategies for important
clinical situations.
B1. Apply drug therapy individualization in
patients with:
• Renal insufficiency.
• Hepatic disease.
• Metabolic genetic alterations.
B2.Apply therapeutic approaches for management
of: heart failure, ischemic heart disease, acute
coronary syndromes, atrial fibrillation, essential
hypertension, hypertensive emergency and
hyperlipidemia.
B3.Illustrate emergency management of different
types of shock, cardiopulmonary arrest, and
diabetic ketoacidosis.
B4. Formulate therapeutic strategies for common
acute and chronic gastrointestinal, neurologic,
immunologic, hematologic, rheumatologic,
infectious, and endocrinal disorders.
B5. Employ the special precautions needed in
pediatric and geriatric patients and pregnancy.
C.
Professional
and Practical
Skills
C1 Add to the practice of the
specialty and research through
creativity & innovation
C2. Assessment of drug regimens in
different clinical situations in the
hospitalized patients
C3. Criticize specific drugs in specific
C1.Criticize different therapeutic approaches for
common medical problems.
C2.Organize a plan for therapeutic management
of patients with comorbidities.
C3.Apply the pharmacological knowledge in
finding common medical errors.
situations
C5. Implement drug safety on
rational drug use
C7. Monitor adverse drug reactions
C4.Design systematic approaches for emergency
management.
C5.Use trials to compare the appropriateness of
different therapeutic approaches in specific
populations.
D. General
Skills
D1 Hold skills to critically
evaluate evidence presented by
publications.
D2. Acquiring new communication
skills in designing and delivering
talks and lectures
D3. Train in team working
D1.Perform practice-based improvement activities
using a systematic methodology.
D2.Appraise evidence from scientific studies.
D3.Participate in one audit related to
pharmacology.
Attitudes and ethical behavior
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs.
E2. Obtain consent that is truly
informed
E3. Manage special challenges of
performing clinical research in
vulnerable populations
E4. Manage confusion of roles in
academic medical centers and
problems with duplicative,
interactive, or conflicting drug
treatment plans
E5. Integrate with other members of
medical team to provide the
patients the appropriate medical
care
E7. Show respect to professors,
colleagues, other members of
.E1 Apply regulations and ethics that govern
physicians in promotion and detailing of variable
prescribed drugs.
E2. Obtain consent that is truly informed before
patient participation in any trials
E3. Manage special challenges of performing clinical
research in vulnerable populations
E4. Manage confusion of roles in academic medical
centers and problems with duplicative, interactive, or
conflicting drug treatment plans
E5. Integrate with other members of medical team to
provide the patients the appropriate medical care for
common diseases
E7. Show respect to professors, colleagues, other
members of medical team and to patients.in teaching
and medical practice
medical team and to patients.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
A. Recent guidelines in
management of common
diseases.
✓ ✓
B. General concepts:
1. Principles of rational drug use ✓
2. Clinical Use Of Antimicrobial
Drugs
✓
3. Clinical Use of HCV & HIV
Drugs
✓
4. Management of Rheumatoid
Arthritis
✓
5. Drug Therapy Individualization
in Patients with Hepatic Disease
or Genetic Alterations in Drug
Metabolizing Activity
✓ ✓
6. Clinical Use of Antiepileptic
Drugs
✓
7. Drug Therapy Individualization
for Patients with Renal
Insufficiency
✓ ✓
8. Pain Management
✓
C. Clinical sessions: Problem
based learning on
C.V.S. Disorders - I
Essential Hypertension
Hypertensive emergency
Hypertension in pregnancy
Heart Failure
✓ ✓ ✓
C.V.S. Disorders - II
Ischemic Heart Disease
✓ ✓
✓
Acute Coronary Syndromes
Atrial Fibrillation
Hyperlipidemia
Respiratory Disorders:
Bronchial Asthma
Community Acquired Pneumonia
Nosocomial Pneumonia
Tuberculosis
✓ ✓ ✓
GIT Disorders:
Chronic Inflammatory Bowel Disease
Peptic Ulcer Disease
Portal Hypertension and Cirrhosis
Viral Hepatitis
Traveler’s Diarrhea
✓
Neurologic Disorders:
Ischemic Stroke
Generalized Tonic-Clonic Seizures.
Parkinson’s Disease
Migraine
✓ ✓ ✓
Endocrinology, Metabolism, and
Diabetes Disorders- I:
Diabetes Mellitus (NIDDM)
Diabetes Mellitus (IDDM)
Hyperthyroidism
Hypothyroidism
✓ ✓ ✓
Immunologic And Rheumatologic
Disorders:
Rheumatoid Arthritis
Osteoarthritis
Gout and Hyperuricemia
Solid-Organ Transplantation
✓ ✓ ✓
Hematologic Disorders:
Iron Deficiency Anemia
Megaloplastic Anemia
Acute Leukemia
HIV infection
✓ ✓ ✓
Infectious Disease-I:
Bacterial Meningitis
Typhoid fever
Osteomyelitis
Urinary Tract Infections
✓ ✓ ✓
Infectious Disease-II:
Cellulitis
Infective Endocarditis
Intraabdominal Infections
Gonorrhea
✓ ✓ ✓
Pediatric Disorders:
Pediatric Gastroenteritis
Rheumatic fever
Meningitis in childhood
Acute childhood leukemia
✓ ✓ ✓
Geriatric Disorders:
Dementia
Urinary Incontinence
Osteoporosis
✓ ✓ ✓
Emergency:
Cardiopulmonary Arrest
Anaphylactic shock
Sepsis and Septic Shock
Diabetic ketoacidosis
✓ ✓ ✓
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam 30 %
Others:
List of Textbooks and References
Lecture Notes
Course Text Books
• Katzung Basic and Clinical
Pharmacology
• Martindale: The Extrapharmacopoeia
• JM Ritter, LD Lewis, TG Mant & A
✓ ✓
✓
✓
Ferro (Eds.), A Textbook of Clinical
Pharmacology and Therapeutics.
• Harrison’s Principles of Internal
Medicine
Suggested Extra Reading
Journals and Periodicals, others
• British journal of Pharmacology
• The Journal of Clinical Pharmacology
Course Instructor:
Name: Signature:
Program Coordinator:
Name: Signature:
Program Director (Head of Department):
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060908 Course Name: Drug Safety
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours 1 Theoretical Clinical/Practical
Course Aims
Develop specialized knowledge and skills required to monitor and manage clinical trials and to conduct
drug safety and Pharmacovigilance activities including adverse reaction reporting and preparing
periodic safety update reports. Providing the foundation and practical knowledge to formulate a sound
clinical development plan; ensure clinical trial data is credible and accurate; and that the rights,
integrity and confidentiality of trial subjects are protected
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
1
A. Knowledge
and
Understanding
A20. Understand concept of drug
safety
A21. Recognize adverse drug reactions
A22. Recognize glossary of terms used
in Pharmacovigilance
A1.Explain the role of drug safety in the
successful development and usage of a
medicine to the benefit of patients.
A2. Identify frequent pitfalls related to drug
safety considerations
A3. Discuss how changes in safety
assessment could become part of a new
drug development paradigm
A4. Outline the classification of adverse
events / adverse drug reactions.
A5. Describe the safety reporting
requirements (according to the type of
adverse event / reaction) pre- and post-
approval.
A6. Review causality, severity, probability
of adverse drug reactions
B. Intellectual
skills
B17. Choose tools, techniques and
methodologies in dug safety evaluation
B18. Assess impact of adverse drug
reactions on adherence of patients to
drugs
B19. Evaluate principal methodological
challenges in the reporting, analysis
and interpretation of safety data in
B1.Choose tools, techniques and
methodologies in dug safety evaluation
B2. Evaluate the assessment of causality.
B3.Distinguish the etiology, mechanisms
and pathology of major classes of adverse
drug reactions and interactions.
B4. Appreciate what safety-related
questions need to be answered in early and
late drug development
clinical trials B5. Evaluate principal methodological
challenges in the reporting, analysis and
interpretation of safety data in clinical trials
C.
Professional
and Practical
Skills
C5. Implement drug safety on rational
drug use
C6. Add to the practice of the specialty
and research through creativity &
innovation
C7. Monitor adverse drug reactions
C1. Critically appraise the principles of
risk-benefit analysis and management using
qualitative and quantitative approaches.
C2. Add to the practice of the specialty and
research through creativity & innovation
C3. Appreciate the role of various centers in
practicing drug safety monitoring
D. General
Skills
D1. Hold skills to critically evaluate
evidence presented by publications.
D1. Critically review and interpret the
literature relating to drug safety and usage
D2.Hold skills to critically evaluate
evidence presented by publications
concerning drug safety.
Attitudes and ethical behavior
E7. Show respect to professors,
colleagues, other members of medical
team and to patients
E1. Show respect to professors, colleagues
during lectures and oral presentations, other
members of medical team and to patients
during clinical practice
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Pharmacovigilance Regulations
and Good Pharmacovigilance
✓
Practices (GVP)
2. Organization of a Typical Drug
Safety Department
✓
3. Adverse Drug Reaction types
and Reporting
✓
4. Post Marketing Compliance for
Safety Monitoring
✓
5. Clinical Study and Safety
Reporting Activities
✓
6. GVP Inspections and Audits
7. Clinical Research, Drug Safety,
Pharmacovigilance Project
✓
8. Drug interactions ✓
9. Immune mechanisms in drug
hypersensitivity and Cutaneous
manifestations of adverse drug
reactions
✓
10. Organ specific adverse drug
reactions
✓
11. Pharmacogenetics and
metabolic basis for adverse
drug reactions
✓
12. FDA Publications , Updates and
Medwatch
13. Safe use of drugs in certain
disease conditions, pregnancy,
lactation, elderly and children
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam
Others 30 %
List of Textbooks and References
Lecture Notes
✓
Course Text Books
• 1. Cobert's Manual of Drug Safety and
Pharmacovigilance 2nd Edition
Suggested Extra Reading
• Oxford Handbook of Practical Drug
Therapy (2 ed.).Duncan Richards, Jeffrey
✓ ✓
✓
Aronson, D. John Reynolds, and Jamie
Coleman
Journals and Periodicals, others
• Cobert's Manual Of Drug Safety And
Pharmacovigilance: Medicine & Health
Science Books @ Amazon.com.
Course Instructor
Name: Azza Baraka Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Samia Mohammed Ali Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060909 Course Name: Pharmacoeconomic
Applications
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours 2 Theoretical Clinical/Practical
Course Aims
In general, the candidates will be able to use the decision analysis to model costs and their outcomes.
E.g. Markov model. Moreover, in view of retrospective databases, the candidate within a team will be
able to evaluate the cost and outcomes associated with Alexandria Faculty of Medicine Hospitals and
Pharmacy services.
An outcome for the pharmacology department is the address and the use of pharmacoeconomic
research in decision making regarding drug policy in major health problems
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A23 Recognize recent updates in
measuring costs and sensitivity
analysis
al- Identify the decision analysis
a2- Point the purpose of decision analysis
a3- Label a decision tree
a4- Interpret threshold analysis graphs
a5-Explain when Markov modeling may be
useful
a6- Interpret a pictorial; presentation of
Markov model
a7- outline types of retrospective data base
a8-Predict the importance of measuring
costs and patient outcomes associated with
medication therapy management for high
1 1
risk Medicare patient
a9-Discuss the pharmacoeconomic results
from different countries
a10- paraphrase updated references and
websites on worldwide pharmacoeconomic
guidelines
B. Intellectual
skills
B20. Calculation of average costs
bl- Calculate the average costs and outcome
from a decision tree
b2- Compare and contrast the use of data
from randomized clinical trials (RCT)
versus observation from pharmacoeconomic
study
B21- Share in six studies
b3- Critique six studies that use
retrospective database
b4- Design/ practice a pharmacoeconomic
study that evaluate therapeutic service in
Alexandria main hospital ( for example
antihypertensive, antidiabetic agents)
C.
Professional
and Practical
Skills
C8 Acquire the technical skills (e.g.
developing medical decision trees
c1. Acquire the technical skills (e.g.
developing medical decision trees)
C9. Interpret images/ diagram
Social/ethical skills (e.g. interpretation of
results at the population level,
understanding of ethical issues)
C10. Acquire personal/professional skills
(e.g. functioning within an organization)
c2. Interpret images/ diagram Social/ethical
skills (e.g. interpretation of results at the
population level, understanding of ethical
issues)
c3. Acquire personal/professional skills (e.g.
functioning within an organization)
D. General
Skills
D6. Communicate and share ideas with
professors to Use the computer aided
d1. Communicate and share ideas with
professors to Use the computer aided decision
decision making from drug discovery in
pharmacoeconomic
D7 Communicate and collaborate within a
team Application level (e.g. one should be
able to understand a decision tree that is
conceptualized by others)
D8. Participate in Conceptualization level
(e.g. one can develop a new decision tree)
D9. Within a team design a research
project done in Alexandria Faculty
Medicine about pharmacoeconomic of
neuropathic pain killers, antidiabetic,
antihypertensive d5. Share in completion
of a national research in Alexandria
Somuaha hospital
D10. Share in improving the quality of
practice and patient care in Alexandria
D11. Share in activities of (ISPOR=
International Society for
Pharmacoeconomics and Outcome
research)
making from drug discovery in
pharmacoeconomic
d2. Communicate and collaborate within a
team Application level (e.g. one should be able
to understand a decision tree that is
conceptualized by others)
d3. Participate in Conceptualization level (e.g.
one can develop a new decision tree)
d4. Within a team design a research project
done in Alexandria Faculty Medicine about
pharmacoeconomic of neuropathic pain killers,
antidiabetic, antihypertensive d5. Share in
completion of a national research in Alexandria
Somuaha hospital
d6. Share in improving the quality of practice
and patient care in Alexandria
d7. Share in activities of (ISPOR= International
Society for Pharmacoeconomics and Outcome
research)
Attitudes and ethical behavior
E7. Show respect to professors,
colleagues, other members of medical
team and to patients.
E1. Show respect to professors, colleagues,
during lectures and discussion
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. updates in measuring costs ✓ ✓
2. methods of sensitivity analysis ✓ ✓
3. the use of data from randomized
clinical trials (RCT) versus
observation from
pharmacoeconomic study
✓
4. Critique six studies that use retrospective database
✓ ✓
5. Design/ practice a
pharmacoeconomic study that evaluate
therapeutic service in Alexandria main
hospital ( for example antihypertensive,
antidiabetic agents)
✓ ✓ ✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam 30 %
Others %
✓
✓
✓
✓ ✓
List of Textbooks and References
Lecture Notes
✓
Course Text Books
• Karen L.Rasacati (2014), Essentials of
Pharmacoeconomics, 2nd ed., Wolters
Kluwer, Lippincott, William & Wilkins
Austin, Texas.
• Copeland, R. A., and Anderson, P. S. (2002),
in Textbook of Drug Design and Discovery,
3rd ed., P. Krogsgaard-Larsen, T. Liljefors,
and U. Madsen, eds., Taylor and Francis,
New York,
Suggested Extra Reading
International Society for Pharmacoeconomics
and Outcomes Research membership
Journals and Periodicals, others
Publications of ISPOR= International Society
for Pharmacoeconomics and Outcome
research)
Egyptian Guidelines and reports for Reporting
Pharmacoeconomic Evaluations
Course Instructor
Name: Prof. Inas Darwish Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: Clinical pharmacology
Course Information
Course Code: 05060910 Course Name: Advanced toxicokinetics & Drug poisoning
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Gain advanced knowledge and apply recent laboratory techniques that helps in understanding
the pharmacokinetic aspects of different therapeutic agents and its implications in the field of
drug poisoning and toxicology with exploration of recent guidelines in their evaluation and
management aiming to improve outcome and decrease in both drug related morbidity and
mortality.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A24. Discuss toxicity tests
A25. Discuss applicable lines of
management in drug poisoning.
A26. Discuss drug teratogens.
A27. Discuss drug related
A1. Discuss animal toxicity tests.
A2. Review In Vitro Alternatives to Animal Toxicity .
A3. Define toxicogenomis
A4. Review toxicokinetics.
1 2
carcinogenesis. A5. Discuss recent laboratory investigation
involved in drug related adverse reaction.
A6. Discuss in detail the specific diagnostic tool
for each drug related toxicity.
A7. Discuss general lines of management of
intoxication patient.
A8. Recognize that specific measures of each
agent with the specific antidote if available.
A10. Discuss different categories of teratogenic
drugs.
A11. Discuss optimal drug choice in pregnancy.
A12. Recognize drugs with high carcinogenic
potentials
A13. Discuss in measures to reduce the risk.
B. Intellectual
skills
B22. Explain toxicokinetics.
B23. Choose alternative drugs to avoid
potential drug interactions.
B1Assess Extent of exposure in toxicity studies
B2. Evaluate data from toxicity studies
statistically.
B3. Compare between Single-dose toxicity studies and Repeated-dose toxicity studies
B4. Select optimal drug in patient receiving
other drugs which inhibit or stimulate
metabolizing enzymes.
C.Professional
and Practical
Skills
C11. Apply recent advances in
methodology and laboratory
technology in drug research and
clinical investigations.
C1. Apply recent laboratory techniques in
clinical and analytical toxicology.
C2. Implement the quantitative evaluation of
plasma drug level in drug discovery and
development
C12. Add to the practice of the
specialty and research through
creativity & innovation
C3. Design kinetics of different therapeutic
agents.
C4. Apply the mathematical calculations for
Steady State Analysis of plasma drug level.
D. General
Skills
D1. Hold skills to critically evaluate
evidence presented by publications
or industry.
D1. Identify examples of Pharmacologically
Interesting recent advances in manipulating
drugs with high toxic risk.
D2. Acquire the ability to recognize errors in
prescribing multidrug therapy which may
interact and to correct these errors.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Descriptive Animal Toxicity Tests
✓ ✓
2. In Vitro Alternatives to Animal Toxicity
✓ ✓
3. Toxicogenomics ✓ ✓
4. The objectives of toxicokinetics and the parameters, which may be determined
✓ ✓ ✓
5. Carcinogenic and teratogenic agents, how to minimize the risk
✓ ✓ ✓
6. Quantification of exposure
✓ ✓ ✓
7. Justification of time points for sampling
✓ ✓ ✓
8. Justification of time points for sampling
✓ ✓ ✓
9. Contribution to the setting of dose levels in order to produce
✓ ✓
adequate exposure
10. Extent of exposure assessment in toxicity studies
✓ ✓
11. Extent of exposure assessment in toxicity studies, Complicating factors in exposure interpretation, Route of administration
✓ ✓
12. Determination of metabolites
✓ ✓
13. Statistical evaluation of data
✓ ✓ ✓
14. Analytical methods ✓ ✓ ✓
15. Reporting ✓ ✓ ✓
16. Toxicokinetics in the various areas of toxicity testing - specific aspects
✓ ✓ ✓
17. Single-dose toxicity studies ✓ ✓ ✓
18. Repeated-dose toxicity studies
✓ ✓ ✓
19. Genotoxicity studies and Carcinogenicity
✓ ✓ ✓
20. Reproductive toxicity studies
✓ ✓ ✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment Mid-term 30 %
✓ ✓
✓
✓
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam 30 %
Others %
List of Textbooks and References
Lecture Notes
✓
Course Text Books
• Michael J. Derelanko (2014), Handbook of
toxicology, 3nd ed., Wiley, New York.
• Abou-Donia Mohamed B (2015), Mammalin
toxicology, 1st ed., Wiley, New York.
Suggested Extra Reading
Journals and Periodicals, others
Course Instructor
Name: Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060911 Course Name: Health outcomes and health-related Quality of life
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours: 1 Theoretical Clinical/Practical
Course Aims to:
1. Identify the different patient-reported health outcomes and health-related quality of life
measures.
2. Emphasize on the importance of assessing health-related quality of life.
3. Appraise the reliability and validity of assessing health-related quality of life measures.
4. Distinguish common measures of health-related quality of life.
5. Develop students’ skills in assessment of :
• Health-related outcomes.
• Health-related quality of life.
• Quality-adjusted life-years.
• Health state preferences.
Intended Learning Outcomes (ILOs)
Program ILO Course ILOs
A. Knowledge
and
Understanding
A28 Identify patient-reported health
outcomes and health-related quality of
life measures.
A1. Define health-related quality of life.
A2.Discuss Quality-of-life outcomes
associated with pharmacotherapy.
A3.Outline and estimate measures of health-
related quality of life.
A4. Distinguish the 36-Item Short Form
Health Survey (SF-36).
A5.estimate quality-adjusted life-years
(QALY).
1
B. Intellectual
skills
B24 Apply the health outcomes and
health-related quality of life measures
to pharmacotherapy.
B1. Discriminate types of conditions and
types of treatments which determine the
value of pharmacotherapy based on
health-related quality of life measures.
B2.Distinguish Concepts of respondent
and administrative burden related to the
assessment of health-related quality of
life.
C. General ,
Professional
and Practical
Skills
C1Hold skills to critically evaluate
evidence presented by publications.
C1.Criticize the validity and reliability of
the measured outcomes.
C2. Design a study to assess the health-
related quality of life outcomes of
pharmacotherapy in a specific patient
population.
D. General
Skills
D1. Hold skills to critically evaluate
evidence presented by publications
D2. Acquiring new communication skills in
designing and delivering talks and lectures
D3. Train in team working
D1. critically evaluate evidence presented by
publications
D2. Use new communication skills in designing
and delivering talks and lectures
D3. Train in team working during group discussions
Attitudes and ethical behavior
E7. Show respect to professors,
colleagues, other members of medical
team and to patients
E1. Show respect to professors, colleagues,
during lectures and discussion
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Identify the different patient-
reported health outcomes and
health-related quality of life
✓ ✓
measures.
2. Emphasize on the importance of
assessing health-related quality
of life.
✓ ✓
3. Appraise the reliability and
validity of assessing health-
related quality of life measures.
✓ ✓
4. Distinguish common measures
of health-related quality of life.
✓ ✓
6. Develop students’ skills in
assessment of :
• Health-related outcomes.
• Health-related quality of life.
• Quality-adjusted life-years.
• Health state preferences.
✓
✓
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam
Others: assignment 30 %
List of Textbooks and References
Lecture Notes
✓
Course Text Books
• Martindale: The Extrapharmacopoeia
• JM Ritter, LD Lewis, TG Mant & A Ferro
(Eds.), A Textbook of Clinical Pharmacology
and Therapeutics.
✓ ✓
✓
Suggested Extra Reading
--
Journals and Periodicals, others
• British journal of Pharmacology
• The Journal of Clinical Pharmacology
Course Instructor
Name: Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 052409060 Course Name: Oncology for Clinical
pharmacology
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
By the end of this course, the student is supposed to have the proper knowledge and understanding
about the pathogenesis and criteria of carcinogenesis, the common carcinogens. He should have
detailed information about anti-neoplastic agents, their mechanisms of action, therapeutic uses,
adverse drug reactions and contra-indications. Updated information about guidelines for treatment of
common neoplastic diseases will be discussed in this course
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A1. Discuss the pharmacology and possible
effects of a drug and integrate other
disciplines with clinical pharmacology.
A2. Review the pharmacodynamic and
pharmacokinetic concepts that will help in
understanding basic drug actions.
A4. List the available targets of drug action
A5. Describe the characteristic
specification of each target
A6. Classify each target to different
al- Describe the pathophysiology of cancer.
including the hallmarks of cancer, the
metastatic process, tumour biology, tumour
markers, and mechanisms of resistance.
a2- Discuss the epidemiology of cancer
including various causative factors
(environmental versus non-environmental)
a3- Evaluate the role and appropriateness of
various screening methods
a4- . Identify the main treatment modalities
of cancer
a5- Categorize the different intents of
treatment with chemotherapy and radiation,
1 1
subcategories and superfamilies that have
been so far enrolled
A7. Identify linking signaling cascade of
each target and potential sites where a
drug can possibly intervene starting at cell
surface down to nuclear modulation and
gene expression or repression
A29. Review pharmacokinetic and
pharmacodynamics of
anticancer drugs
including neoadjuvant, adjuvant and
palliative treatment.
a6- Explain the rationale for combination
chemotherapy to treat various types of
cancer
a7- Explain the mechanism of action, place
in therapy and role in conjunction with
chemotherapy. of targeted therapies (e.g.,
vascular endothelial growth factor
inhibitors, epithelial growth factor receptor
inhibitors,)
a8- Discuss the chemotherapy-induced
hematological and non-hematological
adverse effects
a9- Describe the mechanism of various
adverse effects related to biologic/targeted
therapies
a10- Compare and contrast the relevant
available classes of drugs used for the
treatment of chemotherapy-induced side
effects
. a 11- Explain the normal process of
hematopoiesis
A12- Identify various disorders of abnormal
hematopoiesis
B. Intellectual
skills
B25 Analyze relevant information to
determine drug therapy
problems, urgency, and priority
for a given clinical situation
bl- Analyze relevant information to
determine drug therapy problems, urgency,
and priority for a given clinical situation
b2- Interpret various prognostic factors
related to cancer and their impact on
treatment approaches
b3- Develop and justify a therapeutic plan
with follow up for a given clinical situation
b4- Evaluate the quality, accuracy, and
completeness of the therapeutic plan
C.
Professional
and Practical
Skills
C1. Add to the practice of the specialty
and research through creativity &
innovation
c1. demonstrate respect and collaboration in
team functioning
c2. Apply interprofessional patient centered
care principles to reach decisions for
therapeutic alternatives
c3. Acquire personal/professional skills
(e.g. functioning within an organization)
D. General
Skills
D1. Hold skills to critically evaluate
evidence presented by publications
d1. Communicate and share ideas with
professors to Use the computer aided
decision making from drug discovery in
pharmacoeconomic
d2. Communicate and collaborate within a
team Application level (e.g. one should be
able to understand a decision tree that is
conceptualized by others)
Attitudes and ethical behavior
E7. Show respect to professors,
colleagues, other members of medical
team and to patients.
E1. Show respect to professors, colleagues,
during lectures and discussion
Teaching/Leang Methods
Lectures self Practical/ Small Others
Course Content (Units/Topics)
learning Clinical group
discussion
1. Biology of malignant
transformation in haematopoietic
cells
✓ ✓
2. Practical issues in cytotoxic
chemotherapy usage
✓ ✓
3. Biological treatments in cancer
✓
4. Hormones in cancer
✓ ✓
5. Management of GIT cancers:
(Stomach, Colon and rectum,
Exocrine pancreas)
✓ ✓ ✓
6. Management of cancer Bladder ✓ ✓
7. Management of pulmonary
cancer
✓ ✓
8. Management of prostate cancers ✓ ✓
9. Management of CNS cancers ✓ ✓
10. Management of lymphomas and
myeloma
✓ ✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam 30 %
Others %
✓
✓
✓
✓ ✓
List of Textbooks and References
Lecture Notes
✓
Course Text Books
• Katzung Basic and Clinical
Pharmacology
• Martindale: The Extrapharmacopoeia
• JM Ritter, LD Lewis, TG Mant & A
Ferro (Eds.), A Textbook of Clinical
Pharmacology and Therapeutics.
• Harrison’s Principles of Internal
Medicine
Suggested Extra Reading
• Abeloff's Clinical Oncology
• Skin Cancer: Recognition and
Management
Journals and Periodicals, others
International Classification of Diseases (ICD) -
Official publication of the World Health
Organization
• British journal of Pharmacology
The Journal of Clinical Pharmacology
Course Instructor
Name: Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 050209060 Course Name: Acute Care Cardiology
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours 1 Theoretical Clinical/Practical
Course Aims
Gain advanced knowledge in optimizing use of medications for critically ill cardiac patients and
provide advanced clinical training in the areas of critical care pharmacotherapy to develop independent
problem-solving skills . This includes the establishment of a firm knowledge base in cardiovascular
pharmacology. The course will provide an integrated approach to critical cardiovascular medicine and
focus on applying scientific principles to direct patient care.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A30. Understand appropriate
pharmacotherapeutic regimens in
cardiovascular diseases in critically ill
patients
A1. Explain appropriate
pharmacotherapeutic regimens in
cardiovascular diseases in critically ill
patients including cardiogenic shock,
coronary artery disease, heart failure,
valvular disease, and cardiac surgery
perioperative management
A2. Demonstrate knowledge of fundamental
approaches to the evidence-based care of
acute myocardial infarction, congestive
heart failure, unstable arrythmias , and other
0.5 0.5
critical cardiovascular problems.
A31. Recognize specific problems
of prescribing for critically ill
cardiac patient
A3. Discuss the impact of altered
hemodynamic changes on drug
pharmacokinetics.
A4. Explain principles for appropriate
prescription in critically ill patients to
avoid adverse effects, drug interactions
and minimize adverse events.
A32. Recognize guidelines for
managing critically ill cardiac
patient
A5. Review guidelines and evidence-based
practices for prescribing for critically ill
cardiac patient.
B. Intellectual
skills
B26. Apply the standards of practice
for clinical pharmacology to the
critical care practice environment using
a standard process of care.
B1. Apply the standards of practice for
clinical pharmacology to the critical care
practice environment using a standard
process of care.
B2.Develop an approach to conducting a
gap analysis relative to the principles and
values of team-based care in a local critical
care practice environment.
B27. Identify the best practice patterns
to facilitate care of the critically ill
cardiac patient
B3. Appreciate the status of several areas of
active research on cardiovascular
pharmacology.
B4. Identify the best practice patterns to
facilitate care of the critically ill cardiac
patient
C.
Professional
and Practical
Skills
C13. Evaluate the critically ill cardiac
patient condition and recommend
appropriate corresponding
C1. Interpret a patient’s hemodynamic
status and recommend appropriate
corresponding pharmacotherapeutic
pharmacotherapeutic regimens.
regimens.
C2. Evaluate patients and devise a treatment
strategy for patients with cardiogenic shock,
considering pharmacodynamic response to
vasopressors/inotropes.
C3. Optimize drug therapy in patients with
cardiovascular disease
C4.Integrate drug therapy into an overall
cardiovascular disease management plan..
C14. Correctly interpret common
electrocardiographic effects of cardiac
drugs.
C5. Correctly interpret common
electrocardiographic effects of cardiac
drugs.
D. General
Skills
D1. Hold skills to critically evaluate
evidence presented by publications.
D1. Provide appropriate advice to patients
and other healthcare professionals regarding
disease management, including drug
therapy.
D2.Hold skills to critically evaluate
evidence presented by publications
concerning cardiovascular pharmacology.
D3. Assist in the achievement of
performance improvement projects and
goals identified by the cardiology services,
including current projects targeting the
pharmacological care of patients with
myocardial infarction and acute coronary
syndromes .
D4. Satisfy requirements for Continuing
Professional Development.
Attitudes and
ethical
behavior
E7. Show respect to professors,
colleagues, other members of medical
team and to patients.
E1. Show respect to professors, colleagues,
other members of medical team and to
patients during lectures, discussion and clinical
practice
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Pathophysiology and therapy
of Acute Coronary Syndromes
(Introduction)
✓
2. Pharmacotherapy of non-
STEMI/unstable angina
✓
3. Pharmacotherapy of STEMI
(Antithrombotic Therapy in
CV)
✓
4. Guidelines for the
Management of
supraventricular arrhythmias
✓ ✓
5. Pharmacotherapy of ventricular
arrhythmias
✓
6. Treatment of the Patient with
acute heart failure
✓
7. Drug therapy of pulmonary
embolism and DVT
✓
8. Pharmacotherapy Of
HYPERTENSIVE
emergencies
✓
9. Pharmacotherapy of shock ✓
10. Comparison of different
antithrombotics used in
critically ill patient
✓
11. Comparison of different
antihypertensives used in
critically ill patient
✓
12. Comparison of different
antiarrhythmics used in
critically ill patient
✓
13. Guidelines for safe use of
cardiovascular drugs in cardiac
emergencies
✓
14. Role of beta blockers, ACEIs,
CCBs, vasoactive drugs ad
diuretics in cardiac
emergencies
✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam 30 %
Others %
List of Textbooks and References
Lecture Notes
✓
Course Text Books
• Fundamentals of cardiovascular
Pharmacology
• Textbook of Interventional
Cardiovascular Pharmacology
Suggested Extra Reading
• Cardiac Drug Therapy | M. Gabriel Khan |
Springer
• Cardiac Drugs: Kanu Chatterjee, Eric J.,
M.D.
Journals and Periodicals, others
• Cardiovascular Pharmacology and
Therapeutics
Course Instructor
Name: Azza Baraka Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Samia Mohammed Ali Signature:
✓ ✓
✓
✓
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060912 Course Name: Clinical Immunology
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Gain advanced knowledge and clinical skills in diagnosis and treatment of immunological diseases.
Distinguish the role of drug in manipulation of the immunologic functions to suppress or stimulate
cellular and humoural immunity. Recognize the immunosuppressant drugs in organ transplantation and
probable adverse drug reactions. Discuss the genetic variation affecting drug metabolism and
disposition and its reflection on dose modulation and response to treatment.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix)
Course ILOs
A. Knowledge
and
Understanding
A33. Recognize Basic immunologic
Structure and Function
A1a. Discuss the development of
immunological cells.
A1b. Identify the function of immunologic
cells.
A1c. Summarize the immunologic
mediators.
A1d. Describe the regulatory mechanisms
of immune system.
A34. Recognize recent advances in
Immunodeficiency diseases
A2a. classify immunodeficiency diseases.
A2b. discuse drug treatment of Acquired
immunodeficiency disease.
A2c. Discuss adversre effects of drugs used
in treatment of HIV infection.
½ ½
A35. Discuss Recombinant Proteins
used in Immunotherapy
A3a. Discuss development of Recombinant
Proteins
A3b classify Recombinant Proteins
A3c. Explain the use of Recombinant
Proteins in therapy of immunologic
diseases.
A3d. discuss adverse effects of
Recombinant Proteins.
A36. Discuss the drugs used in
immunosuppressive therapy
A4a. classify immunosuppressive drugs
A4b. discuss the use of immunosuppressive
drugs in therapy of immunologic diseases.
A4c. discuss adverse effects of
immunosuppressive drugs.
A37. Discuss the diagnosis and
management of Allergic diseases
A5a. classify allergic diseases.
A5c. discuss the drugs used in treatment of
Allergic diseases.
A5d. discuss adverse effects of the drugs
used in treatment of Allergic diseases.
A38. Discuss the Disease-modifying
antirheumatic drugs (DMARDs)
A6a. classify allergic diseases.
A6b. discuss the drugs used in treatment of
Allergic diseases.
A6c. discuss adverse effects of the drugs
used in treatment of Allergic diseases.
A39. Discuss Autoimmune Diseases
A7a. classify Autoimmune Diseases.
A7b. discuss the Patterns of autoimmune
disease.
A7c. discuss Mechanisms of tissue damage.
A7d. discuss drug Treatment of
autoimmune disease.
A40. Discuss the role of drugs in
Transplantation immunology
A8a. Identify Histocompatibility genetics in
humans.
A8b. discuss Solid organ transplantation
and role of drugs in prevention of rejection.
A8c. discuss Haematopoietic stem cell
transplantation and role of drugs in
prevention of rejection.
B. Intellectual
skills
B28. Choose suitable drugs for
treatment of immunological
diseases .
B1a. Compare the drugs used in
immunotherapy as regard efficacy, safety,
suitability and cost.
B1b. Select optimal drug in in treatment of
immunological diseases.
B29. Choose alternative drugs to avoid
potential drug interactions.
B2a. Select optimal drug in patient with
increased activity of drug metabolizing
enzyme.
B2b. Select optimal drug in patient
receiving other drugs which inhibit or
stimulate metabolizing enzymes.
C.Professional
and Practical
Skills
C11. Apply recent advances in
laboratory investigations in drug
research and clinical diagnosis.
C1a. Apply recent laboratory techniques
diagnosis of immunological diseases
C1b. Implement the newly developed drugs
in formulation of drug regimens.
D. General
Skills
D1. Hold skills to critically evaluate
evidence presented by publications.
D1a. Identify examples of
Pharmacologically Interesting recent
advances in immunosuppressants.
D2. Acquire the ability to recognize errors
in prescribing multidrug therapy, which
may interact on metabolizing enzymes, and
to correct these errors.
Attitudes and
ethical
behavior
E7. Show respect to professors, colleagues,
other members of medical team and
to patients
E1. Show respect to professors, colleagues,
other members of medical team and to
patients during lectures, discussion and clinical
practice
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Recombinant Proteins and
Immunotherapeutics
✓ ✓
2. Drug immunosuppressive therapy ✓ ✓
3. Disease-modifying antirheumatic
drugs (DMARDs)
✓
4. Basic immunology: Structure and
Function
✓ ✓
5. Infection ✓ ✓
6. Immunodeficiency (management of
HIV)
✓
7. Anaphylaxis and Allergic diseases ✓ ✓
8. Treatment of autoimmune disease ✓ ✓
9. Lymphoproliferative Disorders ✓ ✓
10. Immune Manipulation ✓
11. Transplantation immunology ✓ ✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam 30 %
Others %
List of Textbooks and References
Lecture Notes
✓
Course Text Books
• John B. Zabriskie. Essential-Clinical-
Immunology 2009.
• Harrison's PRINCIPLES OF INTERNAL
MEDICINE Seventeenth Edition
Suggested Extra Reading
Journals and Periodicals, others
• J allergy Clin Immunol
Course Instructor
Name: Signature:
✓ ✓
✓
✓
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060913 Course Name: Herbal use in therapy
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Gain advanced knowledge and criticize the highly practiced herbs by Egyptian populations
concerning the international published evidence based one.
Implement national guidelines for optimal use of herb-drug in common disease interventions
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A41. Discuss in details types,
preparations, toxicities of active
principles in herbal medicinal
plants
al- Classify types of active principles in
herbal medicinal plants
a2- Explain factors affecting efficacy or
toxicity by herbs
a3- Identify the pharmaceutically available
herbal preparations
a4- Outline methods of extraction,
purification
a5- Enumerate dosage preparations
derived from medicinal plants
0.5 0.5
a6- Interpret synergistic herbal formula
a7- outline turmeric importance in
medicine
a8-Predict the quality control in
production of herbal remedies
a9-Discuss limitations of prescribing
herbal remedies
a10- Point updated references and
websites on licensed herbal preparations
in Egypt and world wide
B. Intellectual
skills
B30 Use evidence based data to assess
the proper use of herbal preparations
bl- Judge the Safety in prescribing herbal
preparations
b2- Compare evidence based data regarding
herb drug interactions
b3- Critique three international studies done
on herbs
b4- Design/ practice pharmacologic study
evaluate efficacy or adverse effects of three
herbs
C.Professional
and Practical
Skills
C8 Acquire the technical skills (e.g.
developing medical decision trees
C9. Interpret images/ diagram
Social/ethical skills
C10. Acquire personal/professional skills
(e.g. functioning within an organization
c1. Acquire technical skills ,
developing medical decision
c2. Interpret images/ diagram /
results at the population level
c3. Acquire personal/professional
skills (e.g. functioning within an
organization)
D. General
Skills
D12. Communicate and share
ideas with professors to Use the
computer aided evidence based
data regarding herbs
D13. Communicate and
collaborate within a team able to
understand and refined food-drug
herb interaction or allergy
D14. Participate in experimental
studied
D15. Within a team design a
research project done in
Alexandria Faculty Medicine
regarding herbal or homeopathic
modulation of neuropathic pain
killers, antidiabetic,
antihypertensive
D16. Share in completion of a
national research in Alexandria
Somuaha hospital
d1. Communicate and share ideas with
professors to Use the computer aided
evidence based data regarding herbs
d2. Communicate and collaborate
within a team able to understand and
refined food-drug herb interaction or
allergy
d3. Participate in experimental studied
d4. Within a team design a research
project done in Alexandria Faculty
Medicine regarding herbal or
homeopathic modulation of
neuropathic pain killers, antidiabetic,
antihypertensive
d5. Share in completion of a national
research in Alexandria Somuaha
hospital
Attitudes and ethical behavior
E7. Show respect to professors,
colleagues, other members of
medical team and to patients
E1. Show respect to professors,
colleagues, other members of medical
team and to patients during lectures,
discussion and clinical practice
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
Others
discussion
1. Definition and history, classification according to active groups
✓ ✓
2. agency regulates the manufacture or certifies the labeling of herbal preparations
✓ ✓
3. Methods of preparation,
purification, titration
Identification practically, pharmaceutically of selected herbs 1
✓
4. Pharmacological evidence based study of each plant
✓ ✓
5. Pharmacological evidence based study of each plant (5-9)
6.
✓ ✓
Please check (✓) the appropriate method.
Student Assessment
Methods of Assessment
Essay Objective questions
Case OSCE/OSPE
Assignment Logbook fulfillment
Others
Schedule of Assessment
Mid-term 30 %
End of term 70 %
Distribution of Marks
Written Exam 70 %
Practical/Clinical Exam 30 %
Others %
List of Textbooks and References
Lecture Notes
✓
Course Text Books • Herbal drugs as therapeutic agents Analysis, 2nd ed.,
✓ ✓
✓
✓
CRC Press books. New York.
• Copeland, R. A., and Anderson, P. S. (2002), in Textbook of
Drug Design and Discovery, 3rd ed., P. Krogsgaard-Larsen,
T. Liljefors, and U. Madsen, eds., Taylor and Francis, New
York,
Suggested Extra Reading
Journals and Periodicals, others
www.naturalpedia.com/book_ Constituents_of_Medicina...
www.journals.elsevier.com /journal-of-herbal-medicine
Course Instructor
Name: Prof. Inas Darwish Signature:
Program Coordinator
Name: Signature:
Program Director (Head of Department)
Name: Signature:
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