Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M. PHARM SEMESTER- I -EXAMINATION SUMMER 2017
Subject Code:910104 Date: 29/04/2017
Subject Name: Biological Evaluations Clinical Research
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

Define and explain biological standardization? Give its importance. Describe Parallel-line model of bioassay.
06

State and explain microbial limit tests with its applications.
05

Give brief note on ELISA for protein hormones.
05
Q.2

Describe the LAL test for pyrogens.
06

Describe various parameters employed in bioanalytical method development and validation.
05

Write in brief about application of pharmacokinetic in New Drug Development.
05
Q.3

Describe RIA of insulin in brief.
06

Write a note on design, approval and execution of protocol for bioequivalence studies.
05

Explain the scope and contents of Good Laboratory Practices in pre- clinical studies.
05
Q.4

Describe methods used for the evaluation of bioassay.
06

Describe chemical properties of pyrogen and endotoxines.
05

Write a note on evolution of Good Clinical Practices.
05
Q.5

State and explain radio immunoassay? Describe its principle. Give its advantages and limitations.
06

Write a note on Module 4 and Module 5 of CTD describing non-clinical study reports and clinical study reports.
05

Describe one compartment open model-intravenous infusion.
05
Q. 6

Explain: Pharmacokinetic, bioavailability, bioequivalence and steady state.
06

Describe the significance, methods and limitations of sterility test in
Pharmaceutical analysis.
05

Discuss LD50 and ED50. Describe method for their determination.
05
Q.7

Give brief note on design of clinical research protocol.
06

Give method of sterilization any two of followings;
Implants Insulin Catgut.
05

What is toxicity study? Describe briefly the parameters for measuring toxic effect.
05