GUJARAT TECHNOLOGICAL UNIVERSITY

PHARM.D
5th Year

Subject Name: Clinical Research

Subject Code: 858801

Scope: This course is designed to make the students to understand the principles and gain adequate
knowledge regarding the various approaches to drug discovery including clinical phase of development.
Also enables the students to understand and implement all regulatory and ethical requirements that are
required during the process of drug development.

Objectives:At completion of this course, it is expected that students will be able to:
• Know the concept of new drug development process.
• Understand the regulatory and ethical requirements.
• Conduct the clinical trials in accordance to regulatory and ethical requirements.
• Coordinate the clinical trials and promote quality drug trial research

Teaching scheme and examination scheme:

Teaching Scheme Evaluation Scheme Total
Theory Tutorial Practical Total Theory Practical Marks
External Internal External Internal
3 1 0 4 70 30 0 0 100

Topics Hrs %
Weight
age
1. Drug development process:
Introduction
Various Approaches to drug discovery
1. Pharmacological
1 04 8
2. Toxicological
3. IND Application
4. Drug characterization
5. Dosage form
2. Clinical development of drug:
1. Introduction to Clinical trials. 02 4
2. Various phases of clinical trial. 02 4
3. Methods of post marketing surveillance. 02 4
4. Abbreviated New Drug Application submission. 02 4
5. Good Clinical Practice – ICH, GCP, Central drug standard control organisation 12
06
(CDSCO) guidelines.
6. Challenges in the implementation of guidelines. 02 4
7. Ethical guidelines in Clinical Research. 01 2
8. Composition, responsibilities, procedures of IRB / IEC. 01 2
9. Overview of regulatory environment in USA, Europe and India. 06 15
 10. Role and responsibilities of clinical trial personnel as per ICH- GCP
a. Sponsor
b. Investigators
c. Clinical research associate
04 10
d. Auditors
e. Contract research coordinators
f. Regulatory authority

11. Designing of clinical study documents (protocol, CRF, ICF, PIC with 14
06
assignment).
12. Informed consent Process. 01 3
13. Data management and its components. 03 7
14. Safety monitoring in clinical trials. 03 7

Text Books:
1. Principles and Practice of Pharmaceutical Medicine. Lionel D. Edward, Aadrew J. Flether,
Anthony W. Fos, Peter D. Sloaier. Publisher- Wiley. Latest edition.
2. Handbook of clinical research. Julia Lloyd and Ann Raven Ed. Publisher- Churchill
Livingstone. Latest edition.
3. Principles of Clinical Research. Giovanna di Ignazio, Di Giovanna and Haynes. Publisher-
Ergode books. Latest edition.
4. Essentials of Clinical Research. Glasser. Publisher- Springer. Latest edition.

Reference books:
1. Textbook of Clinical Trials. David Machin, Simon Day and Sylvan Green. Publisher- John
Wiley and Sons. Latest edition.
2. Clinical Data Management. R K Rondels, S A Varley, C F Webbs. Publisher- Wiley. Latest
edition.
3. Goodman & Gilman: JG Hardman, LE Limbard, Publishers- McGraw Hill. Latest edition.

Other references:
1. Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for
Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health (Latest
guidelines).
2. International Conference on Harmonization of Technical requirements for registration of
Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline for Good
Clinical Practice.E6. (Latest guidelines).
3. Ethical Guidelines for Biomedical Research on Human Subjects. Indian Council of Medical
Research, New Delhi. (Latest guidelines).
4. Websites of regulatory bodies of different countries.
5. Clinical research journa
 GUJARAT TECHNOLOGICAL UNIVERSITY
PHARM.D
5th Year

Subject Name: PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS

Subject Code: 858802

Scope: This course is designed to impart knowledge regarding various methods and applications of
pharmacoepidemiology and pharmaco-economics in drug safety monitoring, drug approval and regulations

Objectives: Upon completion of this course, it is expected that students will be able to -
a. Understand drugs use pattern and their outcome measures
b. Conduct pharmaco-epidemiological studies
c. Adopt the tools effectively in evaluating risk and benefit of therapy
d. Conduct pharmacoeconomic studies and evaluate the cost-benefit ratio
Teaching scheme and examination scheme:

Teaching Scheme Evaluation Scheme Total

Theory Tutorial Practical Total Theory Practical Marks
External Internal External Internal
3 1 0 4 70 30 0 0 100

Sr. Topic Hr %
Weightage
1. Pharmacoepidemiology : 02 5
Definition and scope:
Origin and evaluation of pharmacoepidemiology need for pharmacoepidemiology,
aims and applications.
Measurement of outcomes in pharmacoepidemiology Outcome measure and 03 8
drug use measures Prevalence, incidence and incidence rate. Monetary units,
number of prescriptions, units of drugs dispensed, defined daily doses and
prescribed daily doses, medication adherence measurement
Concept of risk in pharmacoepidemiology Measurement of risk, attributable risk 03 7
and relative risk, time-risk relationship and odds ratio
Pharmacoepidemiological methods Includes theoretical aspects of various 12 25
methods and practical study of various methods with the help of case studies for
individual methods Drug utilization review, case reports, case series, surveys of
drug use, cross – sectional studies, cohort studies, case control studies, case –
cohort studies, meta – analysis studies, spontaneous reporting, prescription event
monitoring and record linkage system.
Sources of data for pharmacoepidemiological studies Ad Hoc data sources and 03 8
automated data systems.
Selected special applications of pharmacoepidemiology Studies of vaccine 06 12
safety, hospital pharmacoepidemiology, pharmacoepidemiology and risk
management, drug induced birth defects.
2. Phrmacoeconomics:
 Definition, history, needs of pharmacoeconomic evaluations 02 5
Role in formulary management decisions 02 5
Pharmacoeconomic evaluation Outcome assessment and types of evaluation 07 15
Includes theoretical aspects of various methods and practical study of various
methods with the help of case studies for individual methods: Cost –
minimization, cost- benefit, cost – effectiveness, cost utility
3. Applications of Pharmacoeconomics 03 6
Software and case studies (assignment discussion) 02 4

Text books:
1. Pharmacoepidemiology and Pharmacoeconomics: Concepts and Practice. K G Revikumar.
Publisher- Pharma Med Press. Latest edition.
2. Textbook of Pharmacoepidemiology. Brian L. Strom, Stephen E. Kimmel, Sean Hennessy.
Publisher- John Wiley & Sons. Latest edition.
3. A textbook of Clinical Pharmacy Practice: Essential concepts and skills. G Parthasarathi, Karin
Nyfort-Hansen, Milap C. Nahata. Publisher- Orient Longman Pvt. Ltd. Latest edition.

Reference Books:
1. Pharmacoeconomics and outcomes: Applications for patient care, case studies. Graer D W, Lee
J, OdomT D, et al. Publisher- Lippincott Williams and Wilkins. Latest edition.
2. Introduction to Applied Pharmacoeconomics. F. Randy Vogenberg. Publisher- McGraw-Hill.
Latest edition.
3. Pharmacoepidemiology. Brian L Storm. Publisher- John Wiley and Sons, Ltd. Latest edition.
4. Clinical epidemiology- How to do clinical Practice Research. Brian Haynes, David L
Sachett. Publisher- Lippincott Williams and Wilkins. Latest edition.
5. Park’s textbook of Preventive and social medicine. K Park. Bhanot Publishers. Latest
edition.

Other references:
• WHO website (for epidemiology data)
 GUJARAT TECHNOLOGICAL UNIVERSITY
PHARM.D
5th Year

Subject Name: Clinical Pharmacokinetics & Pharmacotherapeutic Drug Monitoring

Subject Code: 858803

Scope: This course is designed to make the students to understand and apply pharmacokinetic principles
in designing / individualizing dosage regimen. Also, enable the students to interpret the plasma drug
range, and hepatic / renal function in optimizing the drug therapy.

Objectives:
On completion of the course, the student shall be able to
1. Design the drug therapy regimen for individual patient
2. Interpret and correlate the plasma drug concentration with patient’s thera- peutic outcome.
3. Recommend dosage adjustment for patients with renal/ hepatic impairment
4. Detect and manage drug –drug interactions

Teaching scheme and examination scheme:

Teaching Scheme Evaluation Scheme Total
Theory Tutorial Practical Total Theory Practical Marks
External Internal External Internal
2 1 0 3 70 30 0 0 100

Sr. Topic Hr %
Weightage
1. Introduction to Clinical pharmacokinetics 02 5

2. Design of dosage regimens: Nomograms and Tabulations in designing 06 14

dosage regimen, Conversion from intravenous to oral dosing, Determination
of dose and dosing intervals, Drug dosing in the elderly and pediatrics and
obese patients.
3. Pharmacokinetics of Drug Interaction: a. Pharmacokinetic drug 03 7
interactions b. Inhibition and Induction of Drug metabolism c. Inhibition of
Biliary Excretion.
4. Therapeutic Drug monitoring: a. Introduction b. Individualization of drug 12 25
dosage regimen (Variability – Genetic, Age and Weight , disease, Interacting
drugs). c. Indications for TDM. Protocol for TDM. d.
Pharmacokinetic/Pharmacodynamic Correlation in drug therapy. e. TDM of
drugs used in the following disease conditions: cardiovascular disease,
Seizure disorders, Psychiatric conditions, and Organ transplantations
5. Dosage adjustment in Renal and hepatic Disease. a. Renal impairment b. 12 25
Pharmacokinetic considerations c. General approach for dosage adjustment
in Renal disease. d. Measurement of Glomerular Filtration rate and
creatinine clearance. e. Dosage adjustment for uremic patients. f.
Extracorporeal removal of drugs. g. Effect of Hepatic disease on
pharmacokinetics
 6. Population Pharmacokinetics. a. Introduction to Bayesian Theory. b. 05 12
Adaptive method or Dosing with feed back. c. Analysis of Population
pharmacokinetic Data.
7. Pharmacogenetics 05 12
a. Genetic polymorphism in Drug metabolism: Cytochrome P-450
Isoenzymes.
b. Genetic Polymorphism in Drug Transport and Drug Targets.
c. Pharmacogenetics and Pharmacokinetics/Pharmacodynamic
considerations

Text Books:
1. Biopharmaceutics and Applied Pharmacokinetics. Leon Shargel. Publisher- Prentice
Hall. Latest edition.
2. Applied Pharmacokinetics & Pharmacodynamics: Principles of Therapeutic Drug
Monitoring. Michael E. Burton, Leslie M. Shaw, Jerome J. Schentag, William E.
Evans. Publisher- Lippincott Williams & Wilkins. Latest edition.

Reference books:
1. Handbook of Analytical Therapeutic Drug Monitoring and Toxicology. Steven How-
Yan Wong, Irving Sunshine. Publisher- CRC Press. Latest edition.
2. Clinical pharmacokinetics. Soraya Dhillon, Andrzej Kostrzewski. Publisher-
Pharmaceutical Press. Latest edition.
3. Clinical Pharmacokinetics. Rowland and Tozer.. Publisher- Williams and Wilkins. Latest
edition.
4. Principles of Clinical Pharmacology. Arthur J Atkinson. Publisher-TNQ books and
Journals Pvt Ltd. Latest edition

Other references:
1. Therapeutic Drug monitoring, Clinical guide. Abbott Diagnostics. Published by Abbott.
Journals – Clinical Pharmacokinetics, Therapeutic drug monitoring
 GUJARAT TECHNOLOGICAL UNIVERSITY
PHARM.D
5th Year

Subject Name: Clerkship

Subject Code: 858804

In the fifth year, every student shall spend half a day in the morning hours attending ward rounds on daily
basis as a part of clerkship. Theory teaching may be scheduled in the afternoon.

Clerkship examination – Oral examination shall be conducted after the completion of clerkship of students.
An external and an internal examiner will evaluate the student. Students may be asked to present the allotted
medical cases followed by discussion. Students’ capabilities in delivering clinical pharmacy services,
pharmaceutical care planning and knowledge of therapeutics shall be assessed.