GTU B.Pharm 2018 Winter Question Papers || Gujarat Technological University
Seat No.:
Subject Code: 2280011
--- Content provided by FirstRanker.com ---
Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM - SEMESTER - 8- EXAMINATION ~WINTER - 2018
Subject Name: Drug Approval Process
Time: 02:30 PM TO 05:30 PM
--- Content provided by FirstRanker.com ---
Instructions:
- Attempt any five questions.
- Make Suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
- (a) What is SUPAC? Explain the level of changes in SUPAC-MR. 06
--- Content provided by FirstRanker.com ---
(b) Discuss guideline for the post approval changes in SUPAC — IR 05
(c) Explain in brief SUPAC - SS. 05 - (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 - (a) Define new drug according to FDA. Explain in detail the new drug development process with the time course for each phase. 06
(b) What are Bio — similar? How approval of bio similar differs from NDA. 05
(c) Prepare a NDA chart showing NDA review process. 05 - (a) Define DMF. Explain it briefly. 06
(b) Describe the activity regulated by TGA. 05--- Content provided by FirstRanker.com ---
(c) Write note on Purple book. 05 - (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 - (a) What is CDSCO? Outline steps taken by CDSCO in 2015 in making its services responsive, effective and transparent. 06
--- Content provided by FirstRanker.com ---
(b) Explain in detail the sources of new drug. 05
(c) What is bioequivalence? State statistical criteria of Bioequivalence. 05 - (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
--- Content provided by FirstRanker.com ---
--- Content provided by FirstRanker.com ---
Date: 28/11/2018
Total Marks: 80
--- Content provided by FirstRanker.com ---
This download link is referred from the post: GTU B.Pharm 2018 Winter Question Papers || Gujarat Technological University