Download GTU (Gujarat Technological University) B.Pharma (Bachelor of Pharmacy) 2018 Summer 8th Sem 2280011 Drug Approval Process Previous Question Paper
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. - SEMESTER?8 ? EXAMINATION ? SUMMER-2018
Subject Code:2280011
Date: 09/05/2018
Subject Name: Drug Approval Process
Time:10:30am to 01:30pm
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 (a) Explain various phases of drug development.
06
(b) What is investigational new drug (IND)? Explain types of INDs.
05
(c) Enlist various section of IND application. Give Format of application.
05
.
Q.2 (a) What is Orange Book ? List the contents of orange book. Describe coding
10
system for therapeutic equivalence evaluation.
(b) Define bioequivalence. How is it performed? State statistical criteria of
06
Bioequivalence?
Q.3 (a) How to make a FOIA request? Which information is exempted from FOIA?
06
(b) What is DMF? Enlist type of DMF. Discuss DMF Type II.
05
(c) Write note on Inactive Ingredients Guidelines.
05
Q.4 (a) Write short note on ANVISA.
06
(b) Discuss the WHO certification scheme for pharmaceutical products.
05
(c) Write brief note on TGA.
05
Q.5 (a) States the goals of NDA. Discuss general requirements of NDA.
06
(b) Prepare a NDA chart showing NDA review process
05
(c) Write note on supplement NDA.
05
Q. 6 (a) Outline steps taken by CDSCO in February 2015 in making its services
06
responsive, effective and transparent.
(b) Write a note on ANDA. Explain the concept of PARA I to IV filling.
05
(c) What is SUPAC? Discuss the SUPAC guidelines for Immediate release dosage
05
forms.
Q.7 (a) What is CTD? Discuss structure of CTD. How it differs from eCTD.
06
(b) Describe the activity regulated by MHRA.
05
(c) How approval of bio-similar differs from NDA?
05
***************
This post was last modified on 05 March 2021