Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm. SEMESTER • EXAMINATION SUMMER -2018
Subject Code: 910104 Date: 05/05/2018
Subject Name: BIOLOGICAL EVALUATIONS AND CLINICAL RESEARCH
Time: 02:30PM TO 05:30PM 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

Define Bioassay. Explain different types of Bioassay.
06

Explain bioassay of Insulin.
05

What are Pyrogens? Describe the chemistry and biological effects of pyrogens
05
Q.2

What are biological fluids? Explain method of collection of different biological fluids.
06

Write a note on LLE.
05

Write note on Pyrogen testing or LAL test.
05
Q.3

Explain in detail different concepts of pharmaceutical Equivalents. How bioavailability can be measured?
06

Explain the regulatory aspects of bioavailability.
05

Explain Helsinki declaration.
05
Q.4

Write a note on roles and responsibilities of IRB/IEC.
06

Write a note on GCP.
05

Write a note on clinical trial protocol.
05
Q.5

What is Pharmacokinetic? Explain in detail about Cmax and AUC.
06

Explain various pharmacokinetic models.
05

What are the applications of Pharmacokinetics?
05
Q. 6

Explain test for effectiveness of antimicrobial preservatives.
06

Explain toxicity. Explain various parameters for toxicity testing.
05

Explain the sterility testing and microbial limit test in detail.
05
Q.7

Explain the sterility testing of following:
Catgut oily injections Atmospheric air.
06

Write a note on IRMA.
05

Describe objective and study design of clinical trial.
05