Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm SEMESTER-VIII • EXAMINATION SUMMER 2017
Subject Code: 2280011 Date: 09/05/2017
Subject Name: Drug Approval Process
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

What is CCDSCO? Outline steps taken by CDSCO in 2015 in making its services responsive, effective and transparent.
06

Describe content steps of ANDA.
05

What is SUPAC? Discuss the SUPAC guidelines for Immediate release dosage forms.
05
Q.2

How to make a request under FOIA? Which information is exempted from FOIA?
06

Enlist type of Drug Master File and discuss DMF Type II.
05

Write note on CDER guidelines for inclusion of Inactive Ingredients in formulation.
05
Q.3

States the goals of NDA. Discuss general requirements of NDA.
06

Prepare a NDA chart showing NDA review process
05

Explain provisions of supplement NDA.
05
Q.4

What are common Technical documents required for new drug approval? Discuss structure of CTD. How it differs from eCTD.
06

What are Bio-similar? How approval of bio-similar differs from NDA?
05

Describe the activity regulated by USFDA.
05
Q.5

Define Drug. Outline various phases of drug development.
06

What is investigational new drug Explain types of INDs.
05

Enlist various section of IND application. Give Format of application.
05
Q. 6

What is ANVISA? How it differs from ICH guidelines for drug approval.
06

Discuss the WHO certification scheme for pharmaceutical products.
05

Write brief note on TGA.
05
Q.7

Write note on content and application of Orange Book.
08

What is bioequivalence? How is it performed? State statistical criteria of Bioequivalence?
08