Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm SEMESTER-III EXAMINATION WINTER 2017
Subject Code: 930103 Date: 10-11-2017
Subject Name: Clinical Research and Pharmacy Practice
Time: 10:30 am to 01:30 pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Explain the flow of drug development process. Discuss phase I trial in detail.
06

What are the problems in transplantation? How it is managed?
05

Enlist contraindicated drugs during pregnancy and lactation with explanation.
05
Q.2

Explain Drug-Drug interactions of clinical relevance giving suitable examples. What are the methods for minimizing adverse drug interactions?
06

Explain rational drug therapy. Describe the role of pharmacist in overcoming irrational prescribing of drugs.
05

Describe the factors affecting drug response in different racial, ethnic and sex groups.
05
Q.3

Write composition and responsibilities of IRB.
06

Write short note on Investigator Brochure.
05

Discuss various Hematological parameters with their clinical significance.
05
Q.4

Explain the clinical pharmacokinetic parameters and illustrate their significance in patient care.
06

Write short note on Critical Care Therapy.
05

Discuss in brief important aspects of NDA regulations.
05
Q.5

What is inform consent? Write in brief about inform consent process.
06

What is pharmacovigilance? Discuss its status in India. How it can be improved?
05

Explain general principle of clinical toxicology.
05
Q. 6

Describe principles and goals of geriatric therapy.
06

Discuss role and responsibility of Investigator as per ICH GCP guideline.
05

Define ANDA. Discuss AND Application for generic drugs.
05
Q.7

What is TDM? Explain the situations where TDM is useful.
06

Justify clinical investigation of a new drug. Describe phase-I study of clinical trials.
05

Define pharmacoepidemiology. Explain the methods used in epidemiological studies.
05