Gujarat Technological University 2012-2nd Sem M.Pharm - – –, Clinical Research and Regulatory Affairs - Question Paper
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Univesity Name: Gujrat Technological University
Paper name: Clinical Research and Regulatory Affairs
Academic Year: 2012
Courses: M.Pharm 2nd semester exam
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Seat No.:__Enrolment No._
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM- SEM-II-EXAMINATION - JULY 2012 Subject code: 2920206 Date: 09/07/2012
Subject Name: Clinical Research and Regulatory Affairs Time: 10:30 am - 01:30 pm Total Marks: 80
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
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Q.1 |
(a) |
Write on design protocol as per parallel versus cross over designs with suitable example. |
(6) |
|
(b) |
Explain data management in clinical research. |
(5) | |
|
(c) |
Write the importance and essential content of investigator brochure. |
(5) | |
|
Q2 |
(a) |
Explain basic ethical principles and ethical issues in clinical trials. |
(6) |
|
(b) |
What is IND? Enlist the cases in which the clinical hold can be imposed on IND prior to phase I investigation. |
(5) | |
|
(c) |
Write a note on Abbreviated New Drug Application. |
(5) | |
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Q.3 |
(a) |
Write in brief about the various stages of drug discovery to development. Write on Phase IV clinical study. |
(6) |
|
(b) |
Write a note on Institutional Review Board. |
(5) | |
|
(c) |
Explain role of placebo in clinical study. |
(5) | |
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Q.4 |
(a) |
Discuss clinical pharmacology section of NDA. |
(6) |
|
(b) |
Explain role and responsibility of sponsor as per GCP guideline. |
(5) | |
|
(c) |
Give principle of sampling. |
(5) | |
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Q.5 |
(a) |
Explain role and benefits of quality assurance in clinical research. |
(6) |
|
(b) |
Discuss contents of case report form. |
(5) | |
|
(c) |
Explain process to Import Drugs-T licence. |
(5) | |
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Q. 6 |
(a) |
Which data required to be submitted to import and manufacture a new drug already approved in the country as per schedule Y? |
(6) |
|
(b) |
Give outline of IND toxicolology study. |
(5) | |
|
(c) |
Describe data submitted for chemistry requirements of NDA. |
(5) | |
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Q.7 |
(a) |
Explain format and contents of NDA. |
(6) |
|
(b) |
Discuss regulatory requirements and methods of BE/BA studies. |
(5) | |
|
(c) |
Explain essential documents in clinical trials. |
(5) |
|
Attachment: |
| Earning: Approval pending. |
