Download GTU B.Pharma 2018 Winter 8th Sem 2280011 Drug Approval Process Question Paper

Download GTU (Gujarat Technological University Ahmedabad) B.Pharma (Bachelor of Pharmacy) 2018 Winter 8th Sem 2280011 Drug Approval Process Previous Question Paper

Seat No.: ________ Enrolment No.______________

GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM ? SEMESTER ? 8- EXAMINATION ?WINTER - 2018

Subject Code: 2280011
Date: 28/11/2018
Subject Name: Drug Approval Process
Time: 02:30 PM TO 05:30 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 (a) What is SUPAC? Explain the level of changes in SUPAC-MR.
06

(b) Discuss guideline for the post approval changes in SUPAC ? IR
05

(c) Explain in brief SUPAC ? SS.
05



Q.2 (a) Explain the concept of para I to IV and generic exclusivity.
06

(b) Explain in brief regulatory agency ICH.
05

(c) Write a note on CTD.
05



Q.3 (a) Define new drug according to FDA. Explain in detail the new drug
06
development process with the time course for each phase.

(b) What are Bio ? similar? How approval of bio similar differs from NDA.
05

(c) Prepare a NDA chart showing NDA review process.
05



Q.4 (a) Define DMF. Explain it briefly.
06

(b) Describe the activity regulated by TGA.
05

(c) Write note on Purple book.
05



Q.5 (a) Discuss special emphasis on approval under 505 (b) (2).
06

(b) What is INDA? Give the contents of investigation broucher of INDA.
05

(c) Explain registration process of new drug under ANVISA.
05



Q. 6 (a) What is CDSCO? Outline steps taken by CDSCO in 2015 in making its
06
services responsive, effective and transparent.

(b) Explain in detail the sources of new drug.
05

(c) What is bioequivalence? State statistical criteria of Bioequivalence.
05



Q.7 (a) Write note on freedom of Information.
06

(b) Discuss the WHO certification scheme for pharmaceutical products.
05

(c) Describe content and steps of ANDA.
05
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