university: alexandria faculty: medicine programme ...exploring drug discovery and development,...
TRANSCRIPT
الهيئة القومية لضمان جودة التعليم واالعتماد
University: Alexandria
Faculty: Medicine
Programme Specifications
(Academic year: 2016/2017 )
A. Basic Information:
1. Program title: Master 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
1.1 prepare graduates who are able to share in improving the quality of patient care through optimal medication
management based on sound pharmaco-therapeutic principles
1.2 Encourage the student to be capable of working confidently and adopting a mature, professional and safe attitude to their work
1.3 Increase the depth of the student’s knowledge, technical and transferable skills in an integrated manner to enhance their
current and future roles
1.4Encourage the student to develop independent and self-critical learning to maximize their own potential
1.5 Enhance critical, analytical problem-solving skills, evidence-based decision making skills and the use of information
technology
1.6 Develop a deep understanding of human pharmacology, including its application in the clinical setting, as well as its relevance
in the drug development process.
1.7 To develop students’ skills in experimental design, evaluation and interpretation of experimental data, literature searches,
scientific writing, oral presentations, poster presentations and team working.
1.8 Develop an advanced understanding of how clinical, safety and regulatory principles underpin human trials
1.9 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 2007
http://www.pmetb.org.uk/fileadmin/user/QA/Curricula/Approved_curricula/CLINICAL_PHARMACOLOG
Y_AND_THERAPEUTICS/CPT_3_Jul_07_Curr_0010.pdf
الهيئة القومية لضمان جودة التعليم واالعتماد
Domain Academic
Reference
Standards
ILOs
A. Knowledge
and
understandin
g
A1. Review the fundamental principles of pharmacology, drug
discovery and drug development.
A2. Discuss the sources of individual variations in drug response
A3. Explain in depth the molecular mechanisms underlying
pharmacokinetics and pharmacodynamics and their relations to
manifestations and therapy of drug toxicity;
A4. Elucidate the cellular signaling pathways relevant to drug
discovery and disease; considering the associated molecular and
genetic techniques.
A5. Discuss and appraise the clinical management of various clinical
cases, illustrating their related problems; such as adverse drug
reactions, interactions, contraindications, carcinogenicity and
teratogenicity.
A6. Summarize the drug use and management of diseases of special
populations
A7. Review Research ethics and reporting to research ethics
committees (REC).
A8. Describe in details clinical trials, and compare between its
different phases.
A9. Outline the concept of pharmacoeconomics.
A10. Classify types of pharmacoeconomic analysis
A11. Recognize Portfolio and Project Planning and Management in the
Drug Discovery, Evaluation, Development, and Regulatory Review
Process
B. Intellectual
skills
B1. Apply the pharmacokinetic information to justify drug plasma
concentrations according to number of doses given to the patient and to
optimize plasma drug concentration.
B2. Design an evidence-based treatment strategies for a specific
clinical cases in the light of studied pharmacological information to
minimize medication errors
B3. Write a report to research ethics committees (REC).
B4. Design Non-Clinical Drug Development
B5. Perform Preclinical Prediction of Human Pharmacokinetics
B6. Design Phase I Clinical Studies
B7. Construct Design of Clinical drug Development Programs
B8. Review Role of the Administration (e.g. FDA) in Guiding Drug
Development
B9. Compare different types of pharmacoeconomic analysis.
B10. Discuss future perspectives.
B11. apply problem solving skills in experimental and clinical issues
الهيئة القومية لضمان جودة التعليم واالعتماد
C. Professional
skills
C1. Assess drug pharmacokinetics (solubility, absorption/
bioavailability and bioequivalence, distribution and protein binding,
biotransformation, renal excretion), and pharmacodynamics.
C2. work effectively and safely in a clinical and laboratory environment
C3.Recommend the drug (S) of choice for a particular clinical
presentation.
C4.Compare available classes of drugs.
C5.Criticize specific drugs in specific situations
C6.Criticize the Non-Clinical Drug Development
C7.Design a pharmacoeconomic study.
C8. Outline suggestions to improve patients adherence to prescribed
drugs
C9. Communicate basic information about drug therapy to patients and
their families, including purpose of medication, how it works, possible
adverse drug reactions, potential drug interactions, cost, and necessary
follow-up
C10. Identify and recommend appropriate corrections of prescription
errors
C11. Recognize drug compliance and administrations errors and
communicate effectively with patients about them
C12. Recognize patient preferences for treatment, patient concerns and
goals about disease and treatment
D. General and
transferrable
skills
D1. Hold skills of class discussion and critical evaluation of evidence
presented by publications or industry.
D2- Write reports, design poster presentation and give oral presentations
D3- Use web browsing to locate and use online data bases.
D4. Apply effective listening skills and elicit and provide information
using nonverbal, explanatory, and questioning skills.
D5. Integrate effectively with others as a member or leader of a health
care team.
D6. Participate in community and professional organizations.
D7. Report attended seminars, conferences and workshops for further
development.
D8. Plan training courses to improve practice and enhance
performance of juniors.
E. Attitudes and
ethical
behavior
E1. Apply regulations and ethics that govern physicians in promotion
and detailing of drugs.
E2. Explain to patients the possible participation as human research
subjects in clinical trials,
E3. Integrate essential elements for informed consent
E4. Obtain consent that is truly informed
E5. Manage special challenges of performing clinical research in
vulnerable populations
E6. Manage confusion of roles in academic medical centers and
problems with duplicative, interactive, or conflicting drug treatment
الهيئة القومية لضمان جودة التعليم واالعتماد
plans
E7. Integrate with other members of medical team to provide the
patients the appropriate medical care
E8. Apply regulations and ethics during laboratory work on
experimental animals
E9. Show respect to professors, colleagues, other members of medical
team and to patients.
Matrix of Program ILOs/Courses ILO Course
A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11
Clinical pharmacokinetics × × × Basic Pharmacology-I × × × × × Basic Pharmacology –II × × × × × × Drug discovery and development-I × × × ×
Drug discovery and development-II × × × × ×
Optimizing and evaluative patient therapy and assessment of
drug effects × × ×
Pharmacotherapy (Rational use of drugs) × × × × × × Basic Pharmacoeconomics × × Drug metabolism and transport × × × × ×
Applied internal medicine × × × × × × × Applied emergency medicine × × ',,,,Clinical pediatrics × × × × × × Clinical geriatrics × × × × × × Drug poisoning × . ×
ILO Course
B1 B2 B3 B4 B5 B6 B7 B8 B9 B10 B11
Clinical pharmacokinetics × × Basic Pharmacology-I × × Basic Pharmacology –II × × × × Drug discovery and development-I × × × × Drug discovery and development-II × × × × Optimizing and evaluative patient therapy and assessment of drug
effects × × ×
Pharmacotherapy (Rational use of drugs) × × × Basic Pharmacoeconomics × ×
الهيئة القومية لضمان جودة التعليم واالعتماد
Drug metabolism and transport × × × × × Applied internal medicine × × × × Applied emergency medicine × × Clinical pediatrics × × Clinical geriatrics × × Drug poisoning ×
ILO Course
C1 C2
C3 C4 C5 C6 C7 C8 C9 C10 C11 12
Clinical pharmacokinetics × × × × × Basic Pharmacology-I × × × × × × × × Basic Pharmacology –II × × × × × × × × Drug discovery and development-I × Drug discovery and development-II × Optimizing and evaluative patient therapy and assessment of drug
effects × × × ×
Pharmacotherapy (Rational use of drugs) × × × × × × × × Basic Pharmacoeconomics × × Drug metabolism and transport × × × × Applied internal medicine × × × × × × × × × Applied emergency medicine × × × × Clinical pediatrics × × × × Clinical geriatrics × × × Drug poisoning × ×
الهيئة القومية لضمان جودة التعليم واالعتماد
ILO Course
D1-
D2
D3 D4 D5 D6 D7 D8
Clinical pharmacokinetics × × × × × Basic Pharmacology-I × × × × × × Basic Pharmacology –II × × × × × × Drug discovery and development-I × × × × × Drug discovery and development-II × × × × × Optimizing and evaluative patient therapy and assessment of
drug effects × × × ×
Pharmacotherapy (Rational use of drugs) × × × × × × × ×
Basic Pharmacoeconomics × Drug metabolism and transport × Applied internal medicine × Applied emergency medicine × Clinical pediatrics × × × × × × Clinical geriatrics × × × Drug poisoning ×
الهيئة القومية لضمان جودة التعليم واالعتماد
ILO Course
E1 -E2 E3
E4 -E5 E6 E7 E8 -E9
Clinical pharmacokinetics × ×
Basic Pharmacology-I × × × × ×
Basic Pharmacology –II × × × × ×
Drug discovery and development-I × × Drug discovery and development-II × × Optimizing and evaluative patient therapy and assessment of drug effects × × Pharmacotherapy (Rational use of drugs) × × × × Basic Pharmacoeconomics × Drug metabolism and transport × × Applied internal medicine × × × × × × × × × Applied emergency medicine × × × × × × × × × Clinical pediatrics × × × × × × × × × Clinical geriatrics × ×
Drug poisoning ×
5- Curriculum Structure and Contents:
5.1 Programme duration: 40 credit hours
5.2 Programme structure: …………………………………………………………..
Programme courses:
Obligatory:
الهيئة القومية لضمان جودة التعليم واالعتماد
Course Code Course Title Number
of Units
No of Hours/Week
Lectures Practical Clinical
05500801 Basics of research 3
05060801 Clinical pharmacokinetics 2 1 1
05060802 Basic Pharmacology-I 3 2.5 0.5
05060803 Basic Pharmacology –II 3 2 1
05060804 Drug discovery and
development-I
2 2
05060805 Drug discovery and
development-II
2 2
05060806 Optimizing and
evaluating patient's
therapy and assessment of
drug effects
1 0.5 0.5
05060807 Pharmacotherapy
(Rational use of drugs)
4 2 2
05060808 Basic
Pharmacoeconomics
1 1
05060809 Drug metabolism and
transport
1 0.5 0.5
05060810 Applied internal medicine 3 2.5 0.5
05060811 Applied emergency
medicine
1 0.5 0.5
05060812 Clinical pediatrics 2 1 1
05060813 Clinical geriatrics 1 0.5 0.5
05060814 Drug poisoning 3 2 1
6- Curricular Contents:
Clinical pharmacokinetics
Code Course credit hours 2 Pre-requisites
05060801
Theoretical 1 Practical 1 05500801
This course aims at helping the student to acquire advanced knowledge and problem solving skills
to guide drug prescribing based on pharmacokinetic properties of drugs.
Basic Pharmacology-I
Code Course credit hours 3 Pre-requisites
05060802 Theoretical 2.5 Practical 0.5 05500801
الهيئة القومية لضمان جودة التعليم واالعتماد
This course aims to provide the student with the basic knowledge of the essential principles in
pharmacology, To build up the ability of applying this knowledge in recognizing the basic
pharmacology of drugs targeting inflammation, autonomic nervous system, blood components, body
fluid balance, hemostasis, renal system and skin disorders.To enable the student to apply these
pharmacological knowledge in clinical situations in the field of therapeutics And to provide the
student with essential practical skills in pharmacology
Basic Pharmacology-II
Code Course credit hours 3 Pre-requisites
05060803 Theoretical 2 Practical 1 05500801
The course includes knowledge about the essentials of basic pharmacology. Aiming to help students
recognizing the basic pharmacology of drugs targeting infection, autoimmune diseases, cancer, central
nervous, cardiovascular, gastrointestinal, pulmonary, and endocrine systems and to apply these
knowledge in clinical situations in the field of therapeutics. Also it tends to provide the student with
essential practical skills in pharmacology.
Drug discovery and development-I
Code Course credit hours 2 Pre-requisites
05060804 Theoretical 2 Practical 05500801
This course helps the student to acquire advanced knowledge and apply recent techniques that help in
exploring Drug discovery and Development, implement Project Planning and Management in the
Drug Discovery, Evaluation, Development, and Regulatory Review Process
Drug discovery and development-II
Code Course credit hours 2 Pre-requisites
05060805 Theoretical 2 Practical 05500801
This course helps the student to Acquire advanced knowledge and apply recent techniques that help in
exploring Drug discovery and Development, Phase I Clinical Studies, and Distinguish Role of the
Administration (e.g. FDA) in Guiding Drug Development
Optimizing and evaluating patient's therapy and assessment of drug effects
Code Course credit hours 1 Pre-requisites
05060806 Theoretical 0.5 Practical 0.5 05500801
This course helps student to Acquire advanced knowledge enabling the student to assess drug
effect, evaluate and optimize drug therapy.
.
Pharmacotherapy (Rational use of drugs)
Code Course credit hours 4 Pre-requisites
الهيئة القومية لضمان جودة التعليم واالعتماد
05060807 Theoretical 2 Clinical 2 05500801
This Course Aims To enable the student to recognize factors that make patients unique
To build up the ability of applying basic pharmacology knowledge in drug use in common medical
diseases, To provide the student with the essentials of rules and regulation that govern prescribing
To enable the students to identify medication errors, adverse drug reactions and drug interactions.
To develop in the students the skills of Good communication with patients and families, Obtaining
accurate drug history, Developing a sound drug therapy plan, Using information technology and
Finding evidence-based information
Basic Pharmacoeconomics
Code Course credit hours 1 Pre-requisites
05060808 Theoretical 1 Practical 05500801
At the end of the course the student will be able to Define pharmacoeconomic concepts and
terminology. Compare different types of pharmacoeconomic analysis. Apply knowledge to provide
healthcare decision-makers with valuable information and allowing optimal allocation of limited
resources, and discuss future perspectives.
Drug metabolism and transport
Code Course credit hours 1 Pre-requisites
05060809 Theoretical 0.5 Practical 0.5 05500801
This course helps student to Acquire advanced knowledge related to variable types of drug transport
and drug metabolic pathways.
Applied internal medicine
Code Course credit hours 3 Pre-requisites
05060810 Theoretical 2.5 Clinical 0.5 05500801
This course is designed To enable the student to recognize factors that make patients unique
To build up the ability of applying basic pharmacology knowledge in drug use in common medical
diseases, To provide the student with the essentials of rules and regulation that govern prescribing
To enable the students to identify medication errors, adverse drug reactions, drug interactions and
overdosage and To develop in the students the skills of Good communication with patients and
families, Obtaining accurate drug history, Developing a sound drug therapy plan, Using information
technology and Finding evidence-based information
Applied emergency medicine
Code Course credit hours 1 Pre-requisites
05060811 Theoretical 0.5 Clinical 0.5 05500801
The course Discussess basic and advanced measures for management of emergency situations.
Recognize important pharmacokinetic and pharmacodynamic changes in critically ill patients. Gain
advanced knowledge and apply recent guidelines to construct effective management plan in
emergency room
الهيئة القومية لضمان جودة التعليم واالعتماد
Clinical pediatrics
Code Course credit hours 2 Pre-requisites
05060812 Theoretical 1 Clinical 1 05500801
The course aims to help the student to Gain advanced knowledge in optimizing use of medications for
individual children and provide advanced clinical training in the areas of pediatric pharmacotherapy.
The primary emphasis of the course is to develop independent problem-solving skills in pediatrics
pharmacotherapy. This includes the establishment of a firm knowledge base in pediatric
pharmacology and pharmacokinetics; and the ability to provide therapeutic interventions to enhance
the management of pediatric patients.
Clinical geriatrics
Code Course credit hours 1 Pre-requisites
05060813 Theoretical 0.5 Clinical 0.5 05500801
The course aims to help the student to Acquire advanced knowledge and problem solving skills to
guide prescribing in geriatric disorders based on updated guidelines and evidence-based practices.
Drug poisoning
Code Course credit hours 3 Pre-requisites evaluation
05060814 Theoretical 2 Practical 1 05500801
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
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).
10- Methods of student assessment:
Methods Intended Learning outcomes to be
assessed
1. Essay A1-11, B1-11
2. Case studies A1-11, B1-11, C2-5, C7
3. Assignment A1-11, B1-11, D1-12, E1-9
4. Objective questions A1-11, B1-11, C1-12
5. OSCE/OSPE A1-11, B1-11, C1-12, D1-8, E1-9
الهيئة القومية لضمان جودة التعليم واالعتماد
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 Maged Misheal Signature:
Date: / /
Course Specifications
University: Alexandria
Faculty: Medicine
Department: clinical pharmacology
Course Information
Course Code: 05060801 Course Name: Clinical Pharmacokinetics
Program in which the Course is Given MSc in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Acquire advanced knowledge and problem solving skills to guide drug prescribing based on
pharmacokinetic properties of drugs.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A1. Review the fundamental principles
of pharmacology, drug discovery and
drug development.
A2. Discuss the sources of individual
variations in drug response
A3. Explain in depth the molecular
mechanisms underlying
pharmacokinetics and
pharmacodynamics and their relations
to manifestations and therapy of drug
toxicity;
A1.Define pharmacokinetics and
pharmacodynamics
A2. Discuss drug Clearance.
A4. Explain Volume of distribution
A5. State Half-life and elimination rate
constant
A6. Explain Michaelis-menten (saturable or
nonlinear pharmacokinetics)
A7. Outline factors affecting Drug Absorption,
Bioavailability and Bioequivalence
A8. Review the effects of Renal and Liver
Disease on Pharmacokinetics
A9. Compare between Noncompartmental
and Compartmental Approaches to
1 1
Pharmacokinetic Analysis
A10. Describe the effects of liver and renal
diseases on pharmacokinetics
B. Intellectual
skills
B1. Apply the pharmacokinetic
information to justify drug plasma
concentrations according to number of
doses given to the patient and to
optimize plasma drug concentration.
B2. Design a evidence-based treatment
strategies for a specific clinical cases in
the light of studied pharmacokinetic
information to minimize medication
errors
B1. Apply the pharmacokinetic equations
for drug single dose administration
B2. Apply the pharmacokinetic equations
for drug multiple doses administration
B3. Apply the pharmacokinetic equations to
adjust timing to reach steady state situation
B4. Adjust drug dosing in renal and hepatic
impairment.
B5. Design individualized dosage regimens
using one-compartment and Multi-
compartment model equations.
B6. Calculate of clearance, volume of
distribution, and half-life in
pharmacokinetic research studies.
C.Professional
and Practical
Skills
C1. Recommend the drug (S) of choice for
a particular clinical presentation
C2. work effectively and safely in a clinical
and laboratory environment
C3.Recommend the drug (S) of choice for a
particular clinical presentation.
C4.Compare available classes of drugs
C8. Outline suggestions to improve
patients adherence to prescribed drugs
C1. Apply update pharmacokinetic knowledge
to select the best drug for a particular clinical
case
C2.Solve problems of variations of drug
concentration in diseases of organs of
elimination.
C3. Appraise the cardioprotective,
neuroprotective and renoprotective effects of
some drug classes that favor their use over
other counterparts.
C4. Criticize medication errors in some
prescriptions and recommend changes to
improve safety and efficacy of drug therapy.
D. General
Skills
D1. Hold skills of class discussion and
critical evaluation of evidence presented by
publications or industry.
D2- Write reports and give oral
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.
presentations
D3- Use web browsing to locate and
use online data bases.
D4. Communicate basic information about
drug therapy to patients and their families,
including purpose of medication, how it
works, possible adverse drug reactions,
potential drug interactions, cost, and
necessary follow-up
D5. Apply effective listening skills and
elicit and provide information using
nonverbal, explanatory, and questioning
skills.
d3. Demonstrate clinical cases and Display good
time-management during talk, case
presentation and discussion.
D4. Communicate basic information about drug
pharmacokinetics to patients and their families
D5. Apply effective listening skills during
lectures and seminars.
E. Attitudes and ethical behavior
E8. Apply regulations and ethics during
laboratory work on experimental animals
E9. Show respect to professors,
colleagues, other members of medical
team and to patients.
E1. Apply regulations and ethical behavior
toward experimental animals during
laboratory work.
E2. Show respect during listening,
providing oral presentations and
experimental work towards other team
members.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Introduction to pharmacokinetics (Clinical pharmacokinetics vs pharmacodynamics)
✓
2. Clearance, Volume of distribution, Half-life and elimination rate constant
✓
3. Michaelis-menten (saturable or nonlinear pharmacokinetics)
✓
4. Drug Absorption, Bioavailability and Bioequivalence
✓
5. One-compartment model equations for linear pharmacokinetics (Single dose, Multiple-Dose and Steady-State Equations
✓ ✓
6. Designing individualized dosage regimens using one compartment model equations
✓ ✓
7. Multicompartment models ✓ ✓
8. Calculation of clearance, volume of distribution, and half-life in pharmacokinetic research studies
✓ ✓
9. Effects of Renal Disease on Pharmacokinetics
✓ ✓ ✓
10. Effect of Liver Disease on Pharmacokinetics
✓ ✓ ✓
11. Noncompartmental versus Compartmental Approaches to Pharmacokinetic Analysis
✓ ✓ ✓
12. Study problems ✓
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 80 %
Practical/Clinical Exam 20 %
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
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
pharmacokinetics
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: 05060802 Course Name: Basic Pharmacology I
Program in which the Course is Given MS in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
To provide the student with the basic knowledge of the essential principles in pharmacology
To build up the ability of applying this knowledge in recognizing the basic pharmacology of drugs
targeting inflammation, autonomic nervous system, blood components, body fluid balance, hemostasis,
renal system and skin disorders.
To enable the student to apply these pharmacological knowledge in clinical situations in the field of
therapeutics
To provide the student with essential practical skills in pharmacology
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
0.5 2.5
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A2. Discuss the sources of individual
variations in drug response A3- Explain in depth the molecular
mechanisms underlying pharmacokinetics
and pharmacodynamics and their relations
to manifestations and therapy of drug
toxicity;
A4. Elucidate the cellular signaling
pathways relevant to drug discovery and
disease; considering the associated
molecular and genetic techniques.
A5. Discuss and appraise the clinical
management of various clinical cases,
illustrating their related problems; such as
adverse drug reactions, interactions,
contraindications, carcinogenicity and
teratogenicity.
a1.Describe in depth principles and facts
related to the pharmacodynamics of drugs
a2.Identify the detailed pharmacology of
drugs affecting the autonomic nervous
system and their applications in the medical
field
a3.State the pharmacological aspects of
different autacoids and their targeting by
drugs
a4.List drugs used in different types of
anemia
a5.Point different diuretics and their site of
action and adverse effects
a6.Outline vitamins and intravenous fluids
replacement therapy
a7. List drugs used in different
dermatological diseases.
B. Intellectual
skills
B1. Apply the pharmacokinetic
information to justify drug plasma
concentrations according to number of
doses given to the patient and to
optimize plasma drug concentration.
B2. Design an evidence-based
treatment strategies for a specific
clinical cases in the light of studied
pharmacological information to
minimize medication errors
B1.Describe the mechanism of action and
drug interactions related to the autonomic
nervous system, inflammation and
homeostasis
B2.Classify diuretics and discuss their side
effects in relation to their mechanism of
action
B3.Describe vitamins and relate their
physiological aspects to their use in
different clinical states.
C.
Professional
and Practical
Skills
C1. Assess drug pharmacokinetics
(solubility, absorption/ bioavailability and
bioequivalence, distribution and protein
binding, biotransformation, renal
excretion), and pharmacodynamics.
C2. work effectively and safely in a clinical
and laboratory environment
C3.Recommend the drug (S) of choice for a
particular clinical presentation.
C4.Compare available classes of drugs.
C5.Criticize specific drugs in specific
situations
C8. Outline suggestions to improve
patients adherence to prescribed drugs
C9. Communicate basic information about
drug therapy to patients and their
families, including purpose of medication,
how it works, possible adverse drug
reactions, potential drug interactions,
cost, and necessary follow-up
C10. Identify and recommend appropriate
corrections of prescription errors
C1.Compare different diuretics and put a
recommendation of the use of each group in
specific clinical conditions
C2.Organize a plan for therapeutic
management of patients with coagulation
disorders with different comorbidities
C3.Apply the pharmacological knowledge
in management of gout and other rheumatic
disorders
C4.Design systematic approaches for fluid
replacement in different clinical conditions
of fluid imbalance
C5.Use practical experiments to evaluate
the action of analgesics and autonomic
drugs.
C6.Identify examples of recently published
advances in treatment of collagen disorders
C7.Dicuss guidelines of different societies
for the management of thrombotic
disorders, rheumatoid arthritis and
intravenous fluid replacement therapy
C8. Identify problems causing failure of
therapy, and Outline suggestions to avoid or
correct them.
C9. Communicate basic information (purpose of
medication, how it works, possible adverse
drug reactions, potential drug interactions,
cost, and necessary follow-up) about drug
therapy for anemia, renal and inflammatory
diseases, to patients and their families.
D. General
Skills D1. Hold skills of class discussion and D1.Perform practice-based improvement
critical evaluation of evidence presented
by publications or industry.
D2- Write reports, design poster
presentation and give oral presentations
D3- Use web browsing to locate and use
online data bases.
D4. Apply effective listening skills and
elicit and provide information using
nonverbal, explanatory, and questioning
skills.
D7. Report attended seminars,
conferences and workshops for further
development.
D8. Plan training courses to improve
practice and enhance performance of
juniors.
activities using a systematic methodology
D2.Appraise evidence from scientific
studies
D3.Participate in one audit related to
pharmacology
D4. Write two reports about two attended
conferences
D5. Use online data bases to identify the
proper guidelines for certain clinical cases
D6. Apply effective listening skills and elicit
and provide information using nonverbal,
explanatory, and questioning skills during
lectures and during oral presentations
D7. Plan experimental and clinical training
courses to improve practice.
.
E. Attitudes and ethical behavior
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs
E6. Manage confusion of roles in academic
medical centers and problems with
duplicative, interactive, or conflicting drug
treatment plans
E7. Integrate with other members of
medical team to provide the patients the
appropriate medical care
E8. Apply regulations and ethics during
laboratory work on experimental animals
E9. Show respect to professors,
colleagues, other members of medical
E1. Apply regulations and ethics that govern
physicians in promotion and detailing of the
studied drugs
E2. Manage confusion of roles in academic
medical centers and problems with duplicative,
interactive, or conflicting drug treatment plans
related to anemia, gout and dermatological
diseases
E3. Integrate with other members of medical
team to provide the renal, hepatic and cardiac
patients the appropriate medical care
E4. Apply regulations and ethics during
laboratory work on experimental animals
E5. Show respect to professors, colleagues
team and to patients. during lectures and oral presentations, and to
other members of medical team and to
patients during patient counselling.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. General principles of drug action ✓
2. Drugs acting on the autonomic
nervous system
✓ ✓ ✓
3. Autacoids and ergots ✓ ✓
4. Antiinflammatory agents and drugs
used in treatment of gout and
hyperuricemia
✓ ✓
5. Drugs used in anemia and
disorders of haemostasis
✓ ✓
6. Drugs acting on the renal system ✓ ✓
7. Fluids used in the intravenous fluid
therapy
✓ ✓
8. Vitamins ✓ ✓
9. Drugs used in dermatologic
diseases
✓
10. Disinfectants and antiseptics ✓ ✓
11. Practical:
• Effect of drugs on the eye
• Dose-response curve and
drug antagonism
• Evaluation of analgesic
activity of NSAIDs
✓
✓
✓
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 60 %
Practical/Clinical Exam 20 %
Others: essays (assignments) 20%
List of Textbooks and References
Lecture Notes
✓
Course Text Books
• Katzung Basic and Clinical
Pharmacology
• Goodman and Gilmen’s the
Pharmacological Basis of Therapeutics
Suggested Extra Reading
--
✓ ✓
✓
✓
Journals and Periodicals, others
• British journal of Pharmacology
Pharmacological review
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: 05060803 Course Name: Basic Pharmacology II
Program in which the Course is Given MS in Clinical Pharmacology
Number of Credit Hours Theoretical Practical
Course Aims
To develop a deep knowledge of the essentials of basic pharmacology.
To build up the ability of applying this knowledge in recognizing the basic pharmacology of drugs
targeting infection, autoimmune diseases, cancer, central nervous, cardiovascular, gastrointestinal,
pulmonary, and endocrine systems.
To enable the student to apply these pharmacological knowledge in clinical situations in the field of
therapeutics.
To provide the student with essential practical skills in pharmacology.
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A2. Discuss the sources of individual
variations in drug response
A3. Explain in depth the molecular
mechanisms underlying pharmacokinetics
and pharmacodynamics and their relations
to manifestations and therapy of drug
toxicity;
A4. Elucidate the cellular signaling
pathways relevant to drug discovery and
A1. Classify drugs acting on CVS, CNS,
Pulmonary and endocrinal systems
A2. Identify the detailed pharmacology of
drugs Acting on CVS, CNS, Pulmonary and
endocrinal systems
A3. Discuss drugs Used in Treatment of
Infectious Diseases.
A4. State the pharmacological aspects of
different Drugs Used in Cancer Chemotherapy A5. Review recent guidelines for treatment of common cardiovascular, pulmonary, neurological and endocrinal diseases.
1 2
disease; considering the associated
molecular and genetic techniques.
A5. Discuss and appraise the clinical
management of various clinical cases,
illustrating their related problems; such as
adverse drug reactions, interactions,
contraindications, carcinogenicity and
teratogenicity.
A6. Summarize the drug use and
management of diseases of special
populations
A6. Explain in depth the molecular mechanisms underlying pharmacokinetics and pharmacodynamics of drugs acting on CVS, CNS, Pulmonary and endocrinal systems and anticancer drugs. and their relations to adverse drug reactions A7. Discuss the sources of individual variations in response to drugs acting on CVS, CNS, Pulmonary and endocrinal systems and to anticancer drugs
B. Intellectual
skills
B1. Apply the pharmacokinetic
information to justify drug plasma
concentrations according to number of
doses given to the patient and to optimize
plasma drug concentration.
B2. Design an evidence-based
treatment strategies for a specific
clinical cases in the light of studied
pharmacological information to
minimize medication errors B8. Review Role of the Administration (e.g.
FDA) in Guiding Drug Development
B11. apply problem solving skills in
experimental and clinical issues
B1.Describe the mechanisms of action and
drug interactions related to the CVS, CNS,
Pulmonary and endocrinal systems
B2.Classify Immunosuppressant Drugs and
discuss their side effects in relation to their
mechanism of action
B3.Compare between different anticancer
drugs regarding their mechanisms of action,
therapeutic uses and adverse drug reactions.
B4. Identify appropriate method to optimize
plasma drug concentration during treatment of
common cardiovascular, pulmonary,
neurological and endocrinal diseases.
B5. Review Role of the Administration (e.g.
FDA) in Guiding Development of anticancer
drugs and other pharmacological agents.
C.
Professional
and Practical
Skills
C1. Assess drug pharmacokinetics
(solubility, absorption/ bioavailability and
bioequivalence, distribution and protein
binding, biotransformation, renal
excretion), and pharmacodynamics.
C2. work effectively and safely in a clinical
and laboratory environment
C3.Recommend the drug (S) of choice for a
particular clinical presentation.
C4.Compare available classes of drugs.
C5.Criticize specific drugs in specific
situations
C8. Outline suggestions to improve
patients adherence to prescribed drugs
C9. Communicate basic information about
drug therapy to patients and their
families, including purpose of medication,
how it works, possible adverse drug
reactions, potential drug interactions,
cost, and necessary follow-up
C10. Identify and recommend appropriate
corrections of prescription errors
C11. Recognize drug compliance and
administrations errors and communicate
effectively with patients about them
C1.Apply the pharmacological knowledge
in management of clinical cases related to
cardiovascular, respiratory, endocrinal
C2. Select the appropriate drug for common
clinical cases taking into considerations the
causes of individual variations
C3. Recommend drug therapy for common
cardiovascular, infectious, endocrinal and
respiratory diseases, using evidence based
medicine.
C4.Compare available classes of the studied
drugs, and select specific drugs for each clinical
case.
C5.Criticize specific drugs in specific situations.
C6. Identify problems causing failure of
therapy, and Outline suggestions to avoid or
correct them.
C7. Conduct laboratory experiments to
evaluate anticonvulsant activity of drugs,
applying effective, safe and ethical
measures. C8. Conduct laboratory experiments to
Evaluate bronchodilators and
Bronchoconstrictors applying effective, safe
and ethical measures
C9. Communicate basic information (purpose of
medication, how it works, possible adverse
drug reactions, potential drug interactions,
cost, and necessary follow-up) about drug
therapy for common cardiovascular, infectious,
endocrinal and respiratory diseases, to patients
and their families.
D. General
Skills
D1. Hold skills of class discussion and
critical evaluation of evidence presented
D1.Perform practice-based improvement
activities using a systematic methodology
by publications or industry.
D2- Write reports, design poster
presentation and give oral presentations
D3- Use web browsing to locate and use
online data bases.
D4. Apply effective listening skills and
elicit and provide information using
nonverbal, explanatory, and questioning
skills.
D7. Report attended seminars,
conferences and workshops for further
development.
D8. Plan training courses to improve
practice and enhance performance of
juniors.
.
D2.Appraise evidence from scientific
studies
D3.Participate in one audit related to
pharmacology
D4. Write two reports about two attended
conferences
D5. Use online data bases to identify the
proper guidelines for certain clinical cases
D6. Apply effective listening skills and elicit
and provide information using nonverbal,
explanatory, and questioning skills during
lectures and during oral presentations
D7. Plan experimental and clinical training
courses to improve practice.
E. Attitudes and ethical behavior
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs
E6. Manage confusion of roles in academic
medical centers and problems with
duplicative, interactive, or conflicting drug
treatment plans
E7. Integrate with other members of
medical team to provide the patients the
appropriate medical care
E8. Apply regulations and ethics during
laboratory work on experimental animals
E1. Apply regulations and ethics that govern
physicians in promotion and detailing of the
studied drugs
E2. Manage confusion of roles in academic
medical centers and problems with duplicative,
interactive, or conflicting drug treatment plans
related to cardiovascular, neurological and
endocrinal disease
E3. Integrate with other members of medical
team to provide the cancer patients the
appropriate medical care
E4. Apply regulations and ethics during
E9. Show respect to professors,
colleagues, other members of medical
team and to patients.
laboratory work on experimental animals
E5. Show respect to professors, colleagues
during lectures and oral presentations, and to
other members of medical team and to
patients during patient counselling.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Drugs acting on central nervous system.
✓ ✓ ✓
2. Drugs acting on cardiovascular system.
✓ ✓
3. Drugs acting on gastrointestinal system.
✓
4. Drugs acting on pulmonary system. ✓ ✓
5. Drugs acting on endocrine system. ✓ ✓
6. Drugs used in cancer chemotherapy
✓ ✓
7. Immunosuppressant drugs ✓
8. Drugs used in treatment of infectious disease.
✓ ✓ ✓
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 80 %
Practical/Clinical Exam 20 %
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.
Suggested Extra Reading
Journals and Periodicals, others
• British journal of Pharmacology
• Pharmacological review
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: 05060804 Course Name: Drug discovery and Development –I
Program in which the Course is Given MSc 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, and implement Project Planning and Management in the Drug Discovery, Evaluation,
Development, and Regulatory Review Process
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
2
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A4. Elucidate the cellular signaling
pathways relevant to drug discovery and
disease; considering the associated
molecular and genetic techniques
A7. Review Research ethics and report
to research ethics committees (REC).
A11. Recognize Portfolio and Project
Planning and Management in the Drug
Discovery, Evaluation, Development,
and Regulatory Review Process.
a.1 Review Research ethics and report
to research ethics committees (REC).
a.2 Discuss Project Planning and
Management?
a.3 Define Project planning and
management
a.4 Discuss Project planning and
management tools
a.5 Distinguish Project team
management and decision-making.
a.6 Discuss Drug discovery
philosophies and definition of drug
targets
a.7 Explain Generating diversity
a.8 Describe lead structures
a.9 Identify Qualifying leads for
transition to early trials
a.10 Identify Components of non-clinical
drug development
a.11 Distinguish Translational research in
oncology drug development
a.12 Discuss Microdosing
a.13 Identify Allometry
a.14 Distinguish Physiologic
pharmacokinetics
a.15 Recognize Preclinical
Prediction of Human
Pharmacokinetics
B. Intellectual
skills
B3. Write a report to research ethics
committees (REC). B4. Design Non-Clinical Drug Development
B5. Perform Preclinical Prediction of
Human Pharmacokinetics
B7. Construct Design of Clinical drug
Development Programs
b1. Design a report to research ethics
committees (REC).
b2. Report on and interpret Project
Planning and Management?
b3. Build Project planning and
management
b4. Construct Project planning and
management tools
b5. Relate Project team management
and decision-making
b6. Relate Drug discovery philosophies
and definition of drug targets
b7. Report Generating diversity
b8. Build Definition of lead structures
b9. Relate Qualifying leads for
transition to early trials
b10. Describe Components of
non-clinical drug development
b11. Construct Translational
research in oncology drug
development
b12. interpret Microdosing
b13. Analyze Allometry
b14. Analyze Physiologic
pharmacokinetics
C.Professional
and Practical
Skills
C6.Criticize the Non-Clinical Drug
Development
C1. Apply update to predict and develop
Components of non-clinical drug
development
C2. Solve problems of Translational
research in oncology drug
development...etc.
D. General
Skills
d1. Hold skills of class discussion and
critical evaluation of evidence
presented by publications or industry.
D2- Write reports, design poster
presentation and give oral presentations
D3- Use web browsing to locate and use
online data bases.
D4. Apply effective listening skills and elicit
and provide information using nonverbal,
explanatory, and questioning skills.
D7. Report attended seminars,
conferences and workshops for further
development.
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.
D4. Report two attended conferences
D5. Apply effective listening skills during
lectures and oral presentations
E. Attitudes and ethical behavior
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs.
E9. Show respect to professors,
colleagues, other members of medical
team and to patients.
E1. Apply regulations and ethics that govern
physicians in designing pre-clinical and clinical
drug development.
E9. Show respect to professors, colleagues,
other members of medical team and to
patients.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Research ethics and reporting to
research ethics committees (REC).
[in collaboration with Department of
Forensic Medicine]
✓
2. Portfolio and Project Planning and
Management in the Drug Discovery,
Evaluation, Development, and
Regulatory Review Process.
✓
▪ What Is Project Planning and
Management?
✓
▪ Project planning and
management
✓
▪ Project planning and
management tools
✓
▪ Project team management and
decision-making
✓
3. Drug Discovery ✓
▪ Drug discovery philosophies and
definition of drug targets
✓
▪ Generating diversity ✓
▪ Definition of lead structures ✓
▪ Qualifying leads for transition to
early trials
✓
4. Non-Clinical Drug Development ✓
▪ Components of non-clinical drug
development
✓
▪ Translational research in
oncology drug development
✓
5. Preclinical Prediction of Human
Pharmacokinetics
✓
▪ Microdosing ✓
▪ Allometry ✓
▪ Physiologic pharmacokinetics ✓
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 %
Others (attendance/Assignment) 40 %
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
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: 05060805 Course Name: Drug discovery and Development –II
Program in which the Course is Given MSc 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, Phase I Clinical Studies, and Distinguish Role of the Administration (e.g. FDA) in
Guiding Drug Development.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
2
A. Knowledge
and
Understanding
A1. Review the fundamental principles
of pharmacology, drug discovery and
drug development.
A4. Elucidate the cellular signaling
pathways relevant to drug discovery and
disease; considering the associated
molecular and genetic techniques.
A7. Review Research ethics and
reporting to research ethics committees
(REC).
A8. Describe in details clinical trials, and
compare between its different phases.
A11. Recognize Portfolio and Project
Planning and Management in the
Drug Discovery, Evaluation,
Development, and Regulatory
Review Process
a.1 Define Phase I Clinical Studies
a.2 Explain drug toxicity.
a.3 Define Monoclonal antibodies
a.4 Assay of macromolecules
a.5 Describe Interspecies scaling of
macromolecules: predictions in humans
a.6 Explain Pharmacokinetic characteristics
of macromolecules
a.7 Describe Pharmacodynamics of
macromolecules
a.8 Discuss Principles of clinical
development
a.9 Distinguish Legal and regulatory
requirements
a.10 discuss Evidence-based, goal-directed
clinical development
a.11 Review Specific design issues in clinical
development programs
a.12 Review Personalized Medicine, Elderly
and Pediatric Populations, Orphan Drugs,
Comparative Effectiveness, Combination
Treatments, Transparency)
a.13 Recognize The role of the FDA office of
clinical pharmacology.
B. Intellectual
skills
B3. Write a report to research ethics
committees (REC). B6. Design Phase I Clinical Studies
B7. Construct Design of Clinical drug
Development Programs
B8. Review Role of the Administration
(e.g. FDA) in Guiding Drug Development
b1. interpret Monoclonal antibodies
b2. Review methods of Assay of
macromolecules
b3. Construct Interspecies scaling of
macromolecules: predictions in humans
b4. Explain Pharmacokinetic characteristics
of macromolecules
b5. Discuss Legal and regulatory requirements
b6. Analyze Evidence-based, goal-directed
clinical development
b7. interpret Specific design issues in clinical
development programs
b8. Describe Evidence-based, goal-directed
clinical development
b9. Analyze Specific design issues in clinical
development programs
b10. compose Specific design issues in
clinical development programs
b11. Relate Conduct of clinical development
b12. Interpret how does the FDA guide drug
development?
C.Professional
and Practical
Skills
C6.Criticize the Non-Clinical Drug
Development
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.
D2- Write reports, design poster
presentation and give oral presentations
D3- Use web browsing to locate and use
online data bases.
D4. Apply effective listening skills and
elicit and provide information using
nonverbal, explanatory, and questioning
skills.
D7. Report attended seminars,
conferences and workshops for further
development.
d1. Demonstrate competent presentation and
knowledge in class and respect questions 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.
D4. Report two attended conferences
D5. Apply effective listening skills during lectures
and oral presentations
E. Attitudes and ethical behavior
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs.
E9. Show respect to professors,
colleagues, other members of medical
team and to patients.
E1. Apply regulations and ethics that govern
physicians in designing pre-clinical and clinical drug
development.
E9. Show respect to professors, colleagues, other
members of medical team and to patients.
Teaching/Learning Methods
Course Content (Units/Topics)
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Phase I Clinical Studies ✓ ✓
▪ Introduction ✓ ✓
▪ Disease-specific considerations ✓ ✓
▪ Beyond toxicity ✓ ✓
2. Pharmacokinetic and
Pharmacodynamic
Considerations in the
Development of Biotechnology
Products and Large Molecules
✓ ✓
▪ Monoclonal antibodies ✓ ✓
▪ Assay of macromolecules ✓ ✓
▪ Interspecies scaling of
macromolecules: predictions in
humans
✓ ✓
▪ Pharmacokinetic characteristics
of macromolecules
✓ ✓
▪ Pharmacodynamics of
macromolecules
✓ ✓
3. Design of Clinical Development
Programs
✓
▪ Principles of clinical development ✓
▪ Legal and regulatory requirements ✓
▪ Evidence-based, goal-directed
clinical development
✓
▪ Specific design issues in clinical
development programs
✓
▪ Specific design issues in clinical
development programs
✓
▪ Conduct of clinical development ✓
▪ Special topics (Personalized
Medicine, Elderly and Pediatric
Populations, Orphan Drugs,
Comparative Effectiveness,
Combination Treatments,
Transparency)
✓
4. Role of the Administration (e.g. ✓
FDA) in Guiding Drug
Development
▪ Why does the FDA get involved
in drug development?
✓
▪ When does the FDA get involved
in drug development?
✓
▪ How does the FDA guide drug
development?
✓
▪ What are FDA guidances? ✓
▪ The role of the FDA office of
clinical pharmacology
✓
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 (attendance/Assignment) 30%
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
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: 05060806 Course Name: Optimizing and evaluating patient's therapy and assessment of drug effects
Program in which the Course is Given MSc in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Acquire advanced knowledge enabling the student to assess drug effect, evaluate and optimize drug
therapy.
.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A3. Explain in depth the molecular
mechanisms underlying pharmacokinetics
and pharmacodynamics and their relations
to manifestations and therapy of drug
toxicity;
A4. Elucidate the cellular signaling
pathways relevant to drug discovery and
disease; considering the associated
molecular and genetic techniques.
A1. Discuss Physiological and Laboratory Markers of Drug Effect A2.Review the role of Imaging in Drug Development A3. Enumerate Methods of Analysis of Drugs
and Drug Metabolites
A4. Discuss Dose–Effect and Concentration–Effect Analysis
A5. Explain Time Course of Drug Response
A6. State the Pharmacokinetic differences between Men and Women
0.5 0.5
B. Intellectual
skills
B1. Apply the pharmacokinetic
information to justify drug plasma
concentrations according to number of
doses given to the patient and to
optimize plasma drug concentration.
B2. Design an evidence-based
treatment strategies for a specific
clinical cases in the light of studied
pharmacological information to
minimize medication errors
B11. apply problem solving skills in
experimental and clinical issues
B1. Review Physiological and Laboratory Markers of Drug Effect B2. Compare between pharmacokinetics in male and female B3. Classify drugs according to their use in pregnancy and lactation
C.Professional
and Practical
Skills
C1. Assess drug pharmacokinetics
(solubility, absorption/ bioavailability and
bioequivalence, distribution and protein
binding, biotransformation, renal
excretion), and pharmacodynamics.
C2. work effectively and safely in a clinical
and laboratory environment
C3.Recommend the drug (S) of choice for a
particular clinical presentation.
C4.Compare available classes of drugs.
C1. Apply update pharmacologic knowledge to
select the best drug combinations for a
particular indication
C2. Solve problems of polypharmacy, drug
interactions, decline of function of elimination
organs, drug adherence...etc especially in cases
of pregnancy and lactation.
C3. Criticize medication errors in prescriptions
in pregnancy and lactation
D. General
Skills
D1. Hold skills of class discussion and
critical evaluation of evidence presented
by publications or industry.
D2- Write reports and give oral
presentations
D3- Use web browsing to locate and
use online data bases.
D4. Apply effective listening skills and
elicit and provide information using
nonverbal, explanatory, and questioning
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.
skills.
E. Attitudes and ethical behavior
E8. Apply regulations and ethics during
laboratory work on experimental animals
E9. Show respect to professors,
colleagues, other members of medical
team and to patients.
E1. Apply regulations and ethical behavior
toward experimental animals during
laboratory work.
E2. Show respect during listening,
providing oral presentations and
experimental work towards other team
members.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Physiological and Laboratory Markers of Drug Effect
✓ ✓
2. Imaging in Drug Development. ✓ ✓
3. Dose–Effect and Concentration–Effect Analysis
✓ ✓ ✓
4. Time Course of Drug Response ✓ ✓
5. Disease Progress Models
✓ ✓
6. Pharmacokinetic differences between Men and Women
✓
7. Drug Therapy in Pregnant and Nursing Women
✓ ✓
8. Clinical Analysis of Adverse Drug Reactions
✓ ✓
9. Quality Assessment of Drug 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 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
1) Katzung basic and clinical Pharmacology
2) Lippincot' s Pharmacology review
3) Goodman and Gillman Basic
Pharmacology.
Suggested Extra Reading
Journals and Periodicals, others
Review articles on pubmed and Medscape on
drug metabolism
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: 05060807 Course Name: Pharmacotherapy (Rational use of drugs)
Program in which the Course is Given MS in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
To enable the student to recognize factors that make patients unique
To build up the ability of applying basic pharmacology knowledge in drug use in common medical
diseases.
To provide the student with the essentials of rules and regulation that govern prescribing
To enable the students to identify medication errors, adverse drug reactions and drug interactions.
To develop in the students the skills of:
• 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 (refer to program matrix) Course ILOs
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A2. Discuss the sources of individual
variations in drug response
A3. Explain in depth the molecular
mechanisms underlying pharmacokinetics
and pharmacodynamics and their relations
to manifestations and therapy of drug
A1.Review recent guidelines in
management of common diseases.
A2.Identify Principles of rational drug use A3.Discuss Clinical Use Of Antimicrobial Drugs A4.Outline Management of Rheumatoid Arthritis A5. Define Drug Therapy
2 2
toxicity;
A4. Elucidate the cellular signaling pathways
relevant to drug discovery and disease;
considering the associated molecular and
genetic techniques.
A5. Discuss and appraise the clinical
management of various clinical cases,
illustrating their related problems; such as
adverse drug reactions, interactions,
contraindications, carcinogenicity and
teratogenicity.
A6. Summarize the drug use and
management of diseases of special
populations
Individualization. A6. Explain Clinical Use of Antiepileptic Drugs A7. State lines of pain management
B. Intellectual
skills
B1. Apply the pharmacokinetic
information to justify drug plasma
concentrations according to number of
doses given to the patient and to optimize
plasma drug concentration.
B2. Design an evidence-based treatment
strategies for a specific clinical cases in
the light of studied pharmacological
information to minimize medication
errors B11. apply problem solving skills in
experimental and clinical issues
B1.Describe the mechanism of action and
drug interactions related to the
management of common medical diseases
B2.Classify therapeutic approaches for
management of: Heart Failure, Ischemic
Heart Disease, Acute Coronary Syndromes,
Atrial Fibrillation, Hyperlipidemia
B3.Describe emergency management of
acute hepatic failure and acute coronary
syndrome
B4. Differentiate therapeutic guidelines
for treatment of Essential Hypertension,
Hypertensive emergency and Hypertension
in pregnancy
B5. Formulate therapeutic strategies for
common acute and chronic
gastrointestinal, neurologic,
immunologic, hematologic, infectious
and endocrinal disorders, taking into
consideration the special precautions
needed in pediatric and geriatric patients.
C.
Professional
and Practical
Skills
C2. work effectively and safely in a clinical
and laboratory environment
C3.Recommend the drug (S) of choice for a
particular clinical presentation.
C4.Compare available classes of drugs.
C5.Criticize specific drugs in specific
situations
C8. Outline suggestions to improve patients
adherence to prescribed drugs
C9. Communicate basic information about
drug therapy to patients and their families,
including purpose of medication, how it
works, possible adverse drug reactions,
potential drug interactions, cost, and
necessary follow-up
C10. Identify and recommend appropriate
corrections of prescription errors
C11. Recognize drug compliance and
administrations errors and communicate
effectively with patients about them
C12. Recognize patient preferences for
treatment, patient concerns and goals about
disease and treatment
C1.Criticize different therapeutic
approaches for common medical
problems
C2.Organize a plan for therapeutic
management of patients with common
disorders with comorbidities
C3.Apply the pharmacological
knowledge in finding common medical
errors
C4.Design systematic approaches
management of hepatic patients
C5.Use trials to compare the
appropriateness of different therapeutic
approaches in specific populations..
C6. Compare available classes of available
drugs, regarding their efficacy, safety,
suitability and cost.
C7. Communicate effectively with patients
about them
D. General
Skills
D1. Hold skills of class discussion and critical
evaluation of evidence presented by
publications or industry.
D2- Write reports, design poster presentation
d1. Demonstrate competent presentation
and knowledge in class and respect
questions and inquires from colleagues and
professors.
and give oral presentations
D3- Use web browsing to locate and use
online data bases.
D4. Apply effective listening skills and elicit
and provide information using nonverbal,
explanatory, and questioning skills.
D5. Integrate effectively with others as a
member or leader of a health care team.
D6. Participate in community and
professional organizations.
D7. Report attended seminars, conferences
and workshops for further development.
D8. Plan training courses to improve practice
and enhance performance of juniors..
d2. Prove efficient skills in searching
databases and evidence-based guidelines.
d3. Demonstrate clinical cases and Display
good time-management during talk, case
presentation and discussion.
D4. Communicate basic information about
drug pharmacokinetics and
pharmacodynamics to patients and their
families
D5. Apply effective listening skills during
lectures and seminars and during
communication with patients.
Attitudes and ethical behavior
E1. Apply regulations and ethics that govern
physicians in promotion and detailing of
drugs.
E6. Manage confusion of roles in academic
medical centers and problems with
duplicative, interactive, or conflicting drug
treatment plans
E7. Integrate with other members of
medical team to provide the patients the
appropriate medical care
E9. 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 and in communication with patients
and other medical team members.
E2. Manage confusion of roles in academic
medical centers and problems with
duplicative, interactive, or conflicting drug
treatment plans
E3. Integrate with physicians and nurses to
provide the 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 drug councelling.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Recent guidelines in management
of common diseases
✓ ✓ ✓
2. Principles of rational drug use ✓ ✓
3. Clinical Use Of Antimicrobial Drugs ✓ ✓
4. Clinical Use of HCV & HIV Drugs ✓ ✓ ✓
5. Management of Rheumatoid Arthritis
✓ ✓
6. Drug Therapy Individualization in Patients with Hepatic Disease or Genetic Alterations in Drug Metabolizing Activity
✓ ✓ ✓
7. Clinical Use of Antiepileptic Drugs ✓ ✓ ✓
8. Drug Therapy Individualization for Patients with Renal Insufficiency
✓ ✓ ✓ ✓
9. Pain Management ✓ ✓
10. C.V.S. Disorders – I Essential Hypertension
Hypertensive emergency
Hypertension in pregnancy
Heart Failure
✓ ✓ ✓ ✓
11. C.V.S. Disorders - II Ischemic Heart Disease
Acute Coronary Syndromes
Atrial Fibrillation
Hyperlipidemia
✓ ✓
12. 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
Human Immunodeficiency Virus 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
✓ ✓ ✓
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
--
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: 05160801 Course Name: Basic Pharmacoeconomics
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Define pharmacoeconomic concepts and terminology. Compare different types of pharmacoeconomic
analysis. Apply knowledge to provide healthcare decision-makers with valuable information and
allowing optimal allocation of limited resources, and discuss future perspectives.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix)
Course ILOs
A. Knowledge
and
Understanding
A9. Outline the concept of
pharmacoeconomics.
A10. Classify types of
pharmacoeconomic analysis.
A1. Define pharmacoeconomic concepts.
A2. Enumerate the sources and data needed
for pharmacoeconomic studies.
A3. Define cost-of-illness, and cost-
minimization analysis.
A4. Discuss cost-benefit , cost utility
analysis
A5. Explain cost effectiveness and
incremental analysis.
A6. Compare Define sensitivity analysis.
1
B. Intellectual
skills
B9. Compare different types of
pharmacoeconomic analysis.
B10. Discuss future perspectives.
B1. Compare different types of
pharmacoeconomic analysis.
B2. Differentiate between cost
effectiveness and incremental analysis.
B3. Explain how pharmacoeconomics can
enhance clinical practice.
C.Professional
and Practical
Skills
C7.Design a pharmacoeconomic study.
C8. Outline suggestions to improve
C1. Apply pharmacoeconomic analysis on
6 case studies.
C2. Interpret policy decisions for selected
cas studies.
D. General
Skills
D1. Hold skills to critically evaluate
evidence presented by publications or
industry.
D1. Write scientific article under the basics
of scientific research.
D2. Work in a multi-disciplinary team.
A. Attitudes and ethical behavior
E9. Show respect to professors,
colleagues, other members of medical
team and to patients
E1. Show respect to professors, colleagues,
during lectures, seminars and oral
presentations
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
Concept of pharmacoeconomics ✓
Examples of researches and published
data
✓ ✓
Data source for PE ✓
Enhancement of clinical practice by PE
studies
✓
Types of PE analysis ✓ ✓
Objectives and research outcomes ✓
Cost effectiveness and incremental
analysis
✓ ✓
Perspectives in PE And sensitivity
analysis
✓ ✓
Application for 6 case studies ✓
Analysis of data ✓ ✓
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
• Arnold R. (2010), Pharmacoeconomics
From Theory to Practice. CRC Press,
Taylor & Francis Group
• Bootman JL, Townsend RJ, McGhan WF.
Principles of Pharmacoeconomics, 3rd ed.
Cincinnati, OH: Harvey Whitney Books,
✓ ✓
✓ ✓
2005.
• Barner J, Rascati K. Cost-benefit analysis.
In Grauer D, Lee J, Odom T, et al., eds.
Pharmacoeconomics and Outcomes, 2nd
ed. Kansas City, MO: American College of
Clinical Pharmacy, 2003:115–132.
Suggested Extra Reading
Drummond MF, O’Brien BJ, Stoddart GL,
Torrance GW (1997). Basic types of economic
evaluation. In: Drummond MF, O’Brien BJ,
Stoddart GL, Torrance GW (eds). Methods for
the Economic Evaluation of Health Care
Programmes. Oxford University Press: New
York, pp. 6–26.
Journals and Periodicals, others
PharmacoEconomics Journal.
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: 05060809 Course Name: Drug metabolism and transport
Program in which the Course is Given MSc in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Acquire advanced knowledge related to variable types of drug transport and drug metabolic
pathways
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
0.5 0.5
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A2. Discuss the sources of individual
variations in drug response
A3. Explain in depth the molecular
mechanisms underlying pharmacokinetics
and pharmacodynamics and their relations
to manifestations and therapy of drug
toxicity;
A4. Elucidate the cellular signaling
pathways relevant to drug discovery and
disease; considering the associated
molecular and genetic techniques.
A5. Discuss and appraise the clinical
management of various clinical cases,
illustrating their related problems; such as
adverse drug reactions, interactions,
contraindications, carcinogenicity and
teratogenicity.
A1. Identify Basics of genetics
A2. Discuss mechanisms and Genetics of drug
transport.
A3.Define drug metabolism
A4.Review different pathways of drug
metabolism
A5. Illustrate instruments used in analysis
(Chromatographic Separations, Absorption
and Emission Spectroscopy, Immunoaffinity
Assays, Mass Spectrometry, etc)
A6. Enumerate Methods of Analysis of Drugs
and Drug Metabolites
A7. Discuss the role of liver and kidney in drug
metabolism
B. Intellectual
skills
B1. Apply the pharmacokinetic
information to justify drug plasma
concentrations according to number of
doses given to the patient and to
optimize plasma drug concentration.
B2. Design an evidence-based
treatment strategies for a specific
clinical cases in the light of studied
pharmacological information to
minimize medication errors B5. Perform Preclinical Prediction of
Human Pharmacokinetics
B10. Discuss future perspectives.
B11. apply problem solving skills in
experimental and clinical issue
B1. Solve problems of dose adjustment in
renal and hepatic impairment
B2. Report on and interpret:
- Drug-drug interactions
- Drug-disease interaction
- Drug- food interactions.
B3. Design therapeutic plan for specific
clinical cases, avoiding drug
interaction at the level of drug
metabolism and transport .
C.Professional
and Practical
Skills
C1. Assess drug pharmacokinetics
(solubility, absorption/ bioavailability and
bioequivalence, distribution and protein
binding, biotransformation, renal
excretion), and pharmacodynamics.
C2. work effectively and safely in a clinical
and laboratory environment
C3.Recommend the drug (S) of choice for a
particular clinical presentation.
C4.Compare available classes of drugs.
C1. Apply update pharmacologic knowledge to
select the best drug combinations for a
particular indication
C2. Solve problems of polypharmacy, drug
interactions, decline of function of elimination
organs, drug adherence...etc.
C3. Criticize medication errors in some
prescriptions.
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.
E. Attitudes and ethical behavior
E8. Apply regulations and ethics during
laboratory work on experimental animals
E9. Show respect to professors,
colleagues, other members of medical
team and to patients.
E1. Apply regulations and ethical behavior
toward experimental animals during
laboratory work.
E2. Show respect during listening,
providing oral presentations and
experimental work towards other team
members.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Basics of genetics ✓
2. Pathways of Drug Metabolism. ✓
3. Methods of Analysis of Drugs and Drug Metabolites
✓
4. Clinical Pharmacogenetics ✓
5. Mechanisms and Genetics of Drug Transport
✓
6. Drug Interactions ✓
7. Basis of instruments used in analysis, etc
✓ ✓
8. (Chromatographic Separations ✓ ✓
9. Absorption and Emission Spectroscopy
✓ ✓
10. Immunoaffinity Assays ✓ ✓
11. Mass Spectrometry ✓ ✓
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 80 %
Practical/Clinical Exam 20%
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
1) Katzung basic and clinical Pharmacology
2) Lippincot' s Pharmacology review
3) Goodman and Gillman Basic
Pharmacology.
Suggested Extra Reading
Journals and Periodicals, others
Review articles on pubmed and Medscape on
drug metabolism
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: 05060810 Course Name: Applied Internal Medicine
Program in which the Course is Given MS in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
To enable the student to recognise factors that make patients unique
To build up the ability of applying basic pharmacology knowledge in drug use in common medical
diseases.
To provide the student with the essentials of rules and regulation that govern prescribing
To enable the students to identify medication errors, adverse drug reactions, drug interactions and
overdosage.
To develop in the students the skills of:
• 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 (refer to program matrix) Course ILOs
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A2. Discuss the sources of individual
variations in drug response
A3. Explain in depth the molecular
mechanisms underlying pharmacokinetics
and pharmacodynamics and their relations
to manifestations and therapy of drug
A1.Describe the clinical picture of
common cardiovascular, hepatic,
pulmonary, GIT, endocrine and
rheumatic diseases.
A2.Identify the laboratory
investigations required in diagnosing
such disorders
A3.List drugs used in these common
0.5 2.5
toxicity;
A4. Elucidate the cellular signaling pathways
relevant to drug discovery and disease;
considering the associated molecular and
genetic techniques.
A5. Discuss and appraise the clinical
management of various clinical cases,
illustrating their related problems; such as
adverse drug reactions, interactions,
contraindications, carcinogenicity and
teratogenicity.
A6. Summarize the drug use and
management of diseases of special
populations
A8. Describe in details clinical trials, and
compare between its different phases
disorders
A5.Outline approaches in management
of anemias.
A6. . Elucidate the cellular signaling
pathways mediating the
pharmacological actions of drugs used
in common cardiovascular, hepatic,
pulmonary, GIT, endocrine and
rheumatic diseases.
A7. Discuss types of adverse drug
reactions.
A7. Summarize the drug use and
management of diseases of hepatic and
renal patients
A8. Describe in details phases of clinical
trials.
B. Intellectual
skills
B1. Apply the pharmacokinetic
information to justify drug plasma
concentrations according to number of
doses given to the patient and to optimize
plasma drug concentration.
B2. Design an evidence-based treatment
strategies for a specific clinical cases in
the light of studied pharmacological
information to minimize medication
errors B10. Discuss future perspectives.
B11. apply problem solving skills in
experimental and clinical issues
B1.Describe the mechanism of action
and drug interactions related to the
management of common medical
diseases
B2.Classify therapeutic approaches for
management of: viral hepatitis,
anemia, diabetes mellitus,
inflammatory bowel disease,
arrhythmia, rheumatoid a & gouty
arthritis, and systemic lupus
erythematosis
B3.Describe emergency management
of acute hepatic failure and acute
coronary syndrome
B4. Differentiate therapeutic
guidelines for treatment of: liver
cirrhosis, osteoarthritis, adrenocortical
disorders, peptic ulcer, gastro-
intestinal infections, heart failure,
hypertension, dyslipidemia,
pneumonias and tuberculosis.
C. Professional
and Practical
Skills
C2. work effectively and safely in a clinical
and laboratory environment
C3.Recommend the drug (S) of choice for a
particular clinical presentation.
C4.Compare available classes of drugs.
C5.Criticize specific drugs in specific
situations
C6.Criticize the Non-Clinical Drug
Development
C9. Communicate basic information about
drug therapy to patients and their families,
including purpose of medication, how it
works, possible adverse drug reactions,
potential drug interactions, cost, and
necessary follow-up
C10. Identify and recommend appropriate
corrections of prescription errors
C11. Recognize drug compliance and
administrations errors and communicate
effectively with patients about them
C12. Recognize patient preferences for
treatment, patient concerns and goals about
disease and treatment
C1.Criticize different therapeutic
approaches for common medical
problems
C2.Organize a plan for therapeutic
management of patients with common
disorders with comorbidities
C3.Apply the pharmacological
knowledge in finding common
medical errors
C4.Design systematic approaches
managrmrnt of hepatic patients
C5.Use trials to compare the
appropriateness of different
therapeutic approaches in specific
populations..
C6.Identify examples of recently
published advances in treatment of
diabetes
C7. Communicate basic information
about drug therapy of common internal
medicine cases, to patients and their
families, including purpose of medication,
how it works, possible adverse drug
reactions, potential drug interactions,
cost, and necessary follow-up
C8. Identify and recommend appropriate
corrections of prescription errors for
diabetes mellitus
C9. Recognize preferences of diabetic
patient for treatment
D. General Skills
D1. Hold skills to critically evaluate
evidence presented by publications.
D1.Perform practice-based
improvement activities using a
systematic methodology
D2.Appraise evidence from scientific
studies
D3.Participate in one audit related to
pharmacology
E. Attitudes and
ethical behavior
E1. Apply regulations and ethics that govern
physicians in promotion and detailing of
drugs.
E2. Explain to patients the possible
participation as human research subjects in
clinical trials,
E3. Integrate essential elements for
informed consent
E4. Obtain consent that is truly informed
E5. Manage special challenges of performing
clinical research in vulnerable populations
E6. Manage confusion of roles in academic
medical centers and problems with
duplicative, interactive, or conflicting drug
treatment plans
E7. Integrate with other members of
medical team to provide the patients the
appropriate medical care
E8. Apply regulations and ethics during
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs used in common
internal medicine diseases.
E2. Explain to patients the possible
participation as human research
subjects to participate in phase III
clinical trials,
E3. Integrate essential elements for
informed consent taken from the
patient before incorporation in clinical
trial
E4. Obtain consent from patients
tending to participate in clinical trials,
that is truly informed
E5. Manage special challenges of
performing clinical research in
vulnerable populations, like elderly,
diabetic and patients with renal failure
E6. Manage confusion of roles in
academic medical centers and
problems with duplicative, interactive,
or conflicting drug treatment plans
E7. Integrate with other members of
medical team to provide the diabetic,
renal and hepatic patients the
laboratory work on experimental animals
E9. Show respect to professors, colleagues,
other members of medical team and to
patients.
appropriate medical care
E8. Show respect to professors,
colleagues during lectures, seminars and
oral presentation and to other members
of medical team and to patients in clinical
practice.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Viral hepatitis ✓ ✓ ✓
2. Liver cirrhosis & Acute hepatic
failure
✓ ✓
3. Degenerative joint disease
(osteoarthritis)
✓ ✓
4. Rheumatoid arthritis ✓ ✓ ✓
5. Systemic lupus erythematosus ✓ ✓
6. Gouty arthritis ✓ ✓ ✓
7. Approach to anemia ✓ ✓ ✓
8. Diabetes mellitus: type1 & type 2 ✓ ✓ ✓ ✓
9. Chronic adrenocortical
insufficiency (Addison’s disease) &
hypercorticolism (Cushing’s
syndrome)
✓ ✓
10. Peptic ulcer disease
✓ ✓ ✓ ✓
11. Inflammatory bowel disease
✓ ✓
12. Gastrointestinal infections ✓ ✓
13. Acute coronary syndromes ✓ ✓
14. Disturbances in rate and rhythm ✓ ✓
15. Heart failure ✓ ✓
16. Systemic hypertension ✓ ✓ ✓
17. Lipid and lipoprotein disorders ✓ ✓
18. Tuberculosis ✓ ✓
19. Pneumonias ✓ ✓ ✓
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
--
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: 05060811 Course Name: Applied Emergency Medicine
Program in which the Course is Given MD in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Discuss basic and advanced measures for management of emergency situations. Recognize important
pharmacokinetic and pharmacodynamic changes in critically ill patients. Gain advanced knowledge and
apply recent guidelines to construct effective management plan in emergency room.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A3. Explain in depth the molecular
mechanisms underlying pharmacokinetics
and pharmacodynamics and their relations
to manifestations and therapy of drug
toxicity;
A1. discuss the pharmacodynamic and
pharmacokinetic concepts.
A2. discuss the effect of renal and/or
hepatic dysfunction on the dynamic
characteristics of commonly used drugs in
emergency situations.
A3. Discuss changes in sensitivity to some
drugs in liver diseases (Benzodiazepines, β-
Adrenergic blockers, β-Lactam antibiotics).
0.5 0.5
B. Intellectual
skills
B1. Apply the pharmacokinetic
information to justify drug plasma
concentrations according to number of
doses given to the patient and to
optimize plasma drug concentration.
B2. Design an evidence-based
treatment strategies for a specific
clinical cases in the light of studied
pharmacological information to
minimize medication errors
.
B1. Recommend the appropriate use of
different drugs used in myocardial
infarction.
B2. Formulate evidence-based treatment
strategies for patients with acute
decompensated heart failure.
B3. Select the appropriate use of fluids,
vasopressors, antibiotics, and
corticosteroids in patients with sepsis, or
septic shock.
B4. Choose alternative drugs to avoid
potential drug interactions.
B5. Classify patients, assess control, and
select and monitor appropriate acute and
preventive treatments for pediatric and adult
patients with asthma.
B6. Classify factors that influence the
dosing of antibiotics in critical illness (Drug
factors, Patient factors).
C.
Professional
and Practical
Skills
C2. work effectively and safely in a clinical
and laboratory environment
C3.Recommend the drug (S) of choice for a
particular clinical presentation.
C4.Compare available classes of drugs.
C5.Criticize specific drugs in specific
situations
C1. Apply the appropriate calculations for
drug dosing in patients with renal diseases.
C2. Acquire the ability to recognize errors
in prescribing multidrug therapy which may
have significant, life threatening drug
interactions.
D. General
Skills
D1. Hold skills to critically evaluate
evidence presented by publications.
D1. Write scientific article under the basics
of scientific research.
D2. Work in a multi-disciplinary team.
E. Attitudes
and ethical
behavior
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs.
E2. Explain to patients the possible
participation as human research subjects
in clinical trials,
E3. Integrate essential elements for
informed consent
E4. Obtain consent that is truly informed
E5. Manage special challenges of
performing clinical research in vulnerable
populations
E6. Manage confusion of roles in academic
medical centers and problems with
duplicative, interactive, or conflicting drug
treatment plans
E7. Integrate with other members of
medical team to provide the patients the
appropriate medical care
E8. Apply regulations and ethics during
laboratory work on experimental animals
E9. 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 diseases.
E2. Explain to patients the possible
participation as human research subjects to
participate in phase III clinical trials,
E3. Integrate essential elements for
informed consent taken from the patient
before incorporation in clinical trial
E4. Obtain consent from patients tending to
participate in clinical trials, that is truly
informed
E5. Manage special challenges of
performing clinical research in vulnerable
populations, like elderly, diabetic and
patients with renal failure
E6. Manage confusion of roles in academic
medical centers and problems with
duplicative, interactive, or conflicting drug
treatment plans
E7. Integrate with other members of
medical team to provide the diabetic, renal
and hepatic patients the appropriate medical
care
E8. Show respect to professors, colleagues
during lectures, seminars and oral presentation
and to other members of medical team and to
patients in clinical practice.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Pharmacokinetic and ✓ ✓
pharmacodynamic concepts
2. The altered pharmacokinetics
and pharmacodynamics of drugs
commonly used in critically ill
patients.
✓ ✓
3. Management of severe Sepsis
and Septic Shock.
✓ ✓
4. Management of myocardial
infarction.
✓ ✓
5. The use of antimicrobials in
the treatment of infection in
critically ill patient.
✓
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
• Ritter J, Lewis L, Mant T, Ferro A.
(2008) A text book of Clinical
pharmacology and therapeutics, 5th ed.,
Charon Tec Ltd (A Macmillan
Company).
• Park G, and Shelly M. (2001)
Pharmacology of the critically ill. J W
Arrowsmith Ltd, Bristol.
Suggested Extra Reading
• Craig C, Stitzel R. Modern pharmacology
with clinical applications, 6th ed,
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: 05060812 Course Name: Clinical Pediatrics
Program in which the Course is Given MS in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Gain advanced knowledge in optimizing use of medications for individual children and provide
advanced clinical training in the areas of pediatric pharmacotherapy. The primary emphasis of the
course is to develop independent problem-solving skills in pediatrics pharmacotherapy. This includes
the establishment of a firm knowledge base in pediatric pharmacology and pharmacokinetics; and the
ability to provide therapeutic interventions to enhance the management of pediatric patients.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
1 1
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A2. Discuss the sources of individual
variations in drug response
A3. Explain in depth the molecular
mechanisms underlying pharmacokinetics
and pharmacodynamics and their relations
to manifestations and therapy of drug
toxicity;
A4. Elucidate the cellular signaling
pathways relevant to drug discovery and
disease; considering the associated
molecular and genetic techniques.
A5. Discuss and appraise the clinical
management of various clinical cases,
illustrating their related problems; such as
adverse drug reactions, interactions,
contraindications, carcinogenicity and
teratogenicity.
A6. Summarize the drug use and
management of diseases of special
populations
A1.Describe of the developmental changes
in newborns, infants, and children
A2.Discuss age-related changes in
pharmacokinetics (PK) and
pharmacodynamics (PD ) for several
commonly used classes of drugs.
A3.Identify areas of active research on
pediatric pharmacology
A4Explain pediatric clinical trials and
methods of improvement of pediatric drug
study designs
A5. Discuss pathophysiology and
pharmacologic management of pediatric
diseases
A6. Review guidelines for pediatric disease
management
B. Intellectual
skills
B1. Apply the pharmacokinetic
information to justify drug plasma
concentrations according to number of
doses given to the patient and to
optimize plasma drug concentration.
B2. Design an evidence-based
treatment strategies for a specific
clinical cases in the light of studied
pharmacological information to
minimize medication errors
B1. Implicate changes in pharmacokinetics
and pharmacodynamics for dose selection
and assessment of benefits and risks of
drugs used in treating different pediatrics
diseases.
B2. Select most appropriate drugs to treat
pediatric diseases in children with renal or
hepatic impairment
B3. Apply knowledge of drug
pharmacokinetics to select safe drugs to be
given to a lactating child.
C.
Professional
and Practical
Skills
C2. work effectively and safely in a clinical
and laboratory environment
C3.Recommend the drug (S) of choice for a
particular clinical presentation.
C4.Compare available classes of drugs.
C5.Criticize specific drugs in specific
situations
C1. work effectively and safely in a clinical
environment
C2 Recommend rational use of drugs in
pediatrics
C3 Practice pediatric case study, analysis,
drug selection and dose adjustment
C4. Practice methods to promote adherence of
parents to prescribed drugs
D. General
Skills
D1. Hold skills of class discussion and
critical evaluation of evidence presented
by publications or industry.
D2- Write reports, design poster
presentation and give oral presentations
D3- Use web browsing to locate and use
online data bases.
D4. Apply effective listening skills and elicit
and provide information using nonverbal,
explanatory, and questioning skills.
D5. Integrate effectively with others as a
member or leader of a health care team.
. D7. Report attended seminars,
conferences and workshops for further
development
D1. Criticize the challenges inherent in
pediatric clinical trials and awareness of
ongoing efforts to improve on pediatric drug
study designs
D2.Hold skills to critically evaluate
evidence presented by publications
concerning pediatric pharmacology..
D3- Use web browsing to locate and use online
data bases to summarize guidelines for
common pediatric diseases
D4. Report three attended seminars,
conferences related to pediatric medicine
Attitudes and ethical behavior
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs
E9. 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 pediatrics
E9. Show respect to professors, colleagues,
other members of medical team and to
patients in clinical practice
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Developmental
Pharmacodynamics
✓
2. Pharmacometabolomic
Implications for Clinical
Pharmacology
✓
3. Pediatric Pharmacogenetics:
Discovery to Clinical
Implementation
✓
4. How Physiologic Changes in
the child Influence Drug
pharmacokinetics
✓ ✓
5. Optimal Study Design in
Pediatric Clinical
Pharmacology Research
✓
6. Pharmacokinetic Modeling and
Trial Desig
✓ ✓ ✓
7. Pharmacotherapy of CNS ✓ ✓ ✓
diseases in pediatrics
8. Pharmacotherapy of Pediatric
Cardiovascular diseases
✓ ✓ ✓
9. Pharmacotherapy of Pediatric
Infectious diseases
✓ ✓ ✓
10. Pharmacotherapy of Pediatric
endocrine disorders
✓ ✓ ✓
11.Pharmacotherapy of Pediatric
cancer and blood disorders
✓ ✓ ✓
12. Pharmacotherapy of Pediatric
respiratory disorders
✓ ✓ ✓
13. Safe use of drugs for a lactating
child
✓ ✓ ✓
14. Extemporaneous Formulations -
Problems and Solutions
✓ ✓ ✓
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
• .Nelson Textbook of Pediatrics
Suggested Extra Reading
• Textbook on Pediatric Clinical
Pharmacology. The basis of rational drug
therapy in children. Edited by S M
MacLeod.....
Journals and Periodicals, others
• WHO medication handbook in Pediatrics
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: 05060813 Course Name: Clinical Geriatrics
Program in which the Course is Given MSc in Clinical Pharmacology
Number of Credit Hours Theoretical Clinical/Practical
Course Aims
Acquire advanced knowledge and problem solving skills to guide prescribing in geriatric disorders
based on updated guidelines and evidence-based practices.
Intended Learning Outcomes (ILOs)
Program ILO (refer to program
matrix) Course ILOs
0.5 0.5
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A2. Discuss the sources of individual
variations in drug response
A3. Explain in depth the molecular
mechanisms underlying pharmacokinetics
and pharmacodynamics and their relations
to manifestations and therapy of drug
toxicity;
A4. Elucidate the cellular signaling
pathways relevant to drug discovery and
disease; considering the associated
molecular and genetic techniques.
A5. Discuss and appraise the clinical
management of various clinical cases,
illustrating their related problems; such as
adverse drug reactions, interactions,
contraindications, carcinogenicity and
teratogenicity.
A6. Summarize the drug use and
management of diseases of special
populations
A1.Discuss theories of aging process
A2. Mention the physiological changes of
aging
A3. Review the special health needs for this
cohort of population.
A4. Discuss the changes in liver and kidney
functions with aging and impact of these on
plasma drug levels and drugs' half-lives.
A5. Explain the pharmacodynamic changes in
geriatric patient and alterations in
magnitude of drug effects.
A6. Discuss pathophysiology, clinical features,
diagonsis , non-pharmacologic and
pharmacologic management of geriatric
disorders affecting different body systems.
A7. Review updates on guidelines and
evidence-based practices for prescribing.
A8. Discuss nutrition and exercises that can
be prescribed to geriatric patients in
the ambulatory setting as part of their
health maintenance. A9. Discuss the impact of natural products and
herbal medicines used by elderly for
possible interactions with drugs.
A10. Identify principles for appropriate
prescription of drugs in geriatric patients to
avoid adverse effects, drug interactions and
minimize polypharmacy.
A11. Discuss how to promote adherence to a
prescribed drug regimen
B. Intellectual
skills
B1. Apply the pharmacokinetic
information to justify drug plasma
concentrations according to number of
doses given to the patient and to
optimize plasma drug concentration.
B2. Design an evidence-based
treatment strategies for a specific
clinical cases in the light of studied
pharmacological information to
minimize medication errors .
B1. Perform a comprehensive assessment
of clinical case presentation.
B2. Design a treatment plan for the
clinical diagnosis.
B3. Solve problems of dose adjustment in
renal and hepatic impairment.
B4. Incorporate evidence-based medicine
into geriatric medicine.
B5. Report on and interpret:
- Drug history
- previous or current adverse drug
reactions.
- Drug-drug interactions
- Drug-disease interaction
- Drug- food interactions.
B6 Design appropriate methods improve
adherence to a prescribed drug
regimen.
C.Professional
and Practical
Skills
C3.Recommend the drug (S) of choice for a
particular clinical presentation.
C4.Compare available classes of drugs.
C5.Criticize specific drugs in specific
situations .
C1. Apply update pharmacologic knowledge to
select the best drug for a particular indication
C2. Solve problems of polypharmacy, drug
interactions, decline of function of elimination
organs, drug adherence...etc.
C3. Apprise the cardioprotective,
neuroprotective and renoprotective
effects of some drug classes that favor
their use over other counterparts.
C4. Criticize medication errors in some
prescriptions.
D. General
Skills
D1. Hold skills of class discussion and
critical evaluation of evidence
presented by publications or
d1. Demonstrate competent presentation and
knowledge in class and respect questions
and inquires from colleagues and
professors.
industry.
D2- Write reports, design poster
presentation and give oral presentations
D3- Use web browsing to locate and use
online data bases.
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
E1. Apply regulations and ethics that
govern physicians in promotion and
detailing of drugs.
E9. 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 for treatment of common geriatric
diseases.
E2. Show respect to professors, colleagues, other members of medical team and to patients during drug councelling.
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Aging biology ✓
2. Altered pharmacokinetics and Pharmacodynamics in aging population.
✓ ✓ ✓
3. Managing diabetes mellitus and thyroid disease in the elderly
✓ ✓ ✓
4. Issues concerning common infections in elderly.
✓ ✓ ✓
5. Issues in geriatric dermatology ✓ ✓ ✓
6. Dealing with dementia, Alzheimer's disease and depression.
✓ ✓ ✓
7. Pharmacotherapy issues of managing chronic pain in the
✓ ✓ ✓
geriatric population
8. Nutrition and exercise in the elderly
✓
9. Natural medicines used by the elderly
✓
10. Ethical prescribing in the geriatric patient
✓
11. Improving medication use in the elderly and enhancing medication adherence
✓
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 20 %
Others (attendance/Assignment) 20 %
List of Textbooks and References
Lecture Notes
Manuscripts of Assignment Topics prepared
by candidates and revised by supervising
professors.
Course Text Books
Geriatric Pharmacology - The
Principles of Practice & Clinical
Recommendations (by Steven Atkinson)
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
geriatric pharmacology
Course Instructor
Name: Madiha Abdel-Halim 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: 05060814 Course Name: Drug poisoning
Program in which the Course is Given Ms 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
1 2
A. Knowledge
and
Understanding
A1. Review the fundamental principles of
pharmacology, drug discovery and drug
development.
A3. Explain in depth the molecular
mechanisms underlying pharmacokinetics
and pharmacodynamics and their relations
to manifestations and therapy of drug
toxicity;
A1. Define the therapeutic agents most involved
in increased toxic effects.
A2. Discuss their pharmacokinetics in details.
A3. review their recoded toxic effects.
A4. describe recent advances in methods for
clinical assessment of patient with drug
poisoning.
A5. review 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. explain 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. Identify drugs with high carcinogenic
potentials
A13. Discuss in measures to reduce the risk.
B. Intellectual
skills
. B2. Design an evidence-based
treatment strategies for a specific
clinical cases in the light of
studied pharmacological
information to minimize
medication errors
B1. Compare pharmacokinetic aspects of
different alternative.
B2. Select optimal drug suitable to each patient
with specific conditions.
B3. Select optimal drug in patient with
increased activity of drug metabolizing enzyme.
B4. Select optimal drug in patient receiving
other drugs which inhibit or stimulate
metabolizing enzymes.
C.Professional
and Practical
Skills
C5.Criticize specific drugs in specific
situations
C10. Identify and recommend appropriate
corrections of prescription errors
C1. Apply recent laboratory techniques in
clinical and analytical toxicology.
C2. Implement the quantitative evaluation of
plasma drug level in drug discovery and
development
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.
Attitudes and ethical behavior
E9. Show respect to professors,
colleagues, other members of
medical team and to patients
E1. Show respect to professors, colleagues,
Course Content (Units/Topics)
Teaching/Learning Methods
Lectures self
learning
Practical/
Clinical
Small
group
discussion
Others
1. Pharmacology, kinetics, toxic effects of different drugs.
✓ ✓
2. Recent guidelines for evaluation of patient with drug toxicity.
✓ ✓
3. General and specific lines in management of drug toxicity.
✓ ✓
4. Pharmacokinetic and dynamic aspects of intoxication in vulnerable groups.
✓ ✓
5. Carcinogenic and teratogenic agents, how to minimize the risk
✓ ✓
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: