Download GTU B.Pharma 2019 Winter 8th Sem 2280011 Drug Approval Process Question Paper

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Seat No.:

Subject Code: 2280011

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Enrolment No.

GUJARAT TECHNOLOGICAL UNIVERSITY

B.PHARM - SEMESTER- 8 EXAMINATION — WINTER -2019

Subject Name: Drug Approval Process

Time: 02:30 PM TO 05:30 PM

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Instructions:

1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Q.1

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1. Discuss in brief about various phases of drug development and approval. (06)
2. Write note on orange book. (05)
3. What is TGA? Discuss structure of TGA. (05)

Q.2

1. Explain the approval process of new drug under 505 (b) (2). (06)

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2. Give overview on freedom of information. (05)
3. What is drug master file? Discuss various parts of DMF. (05)

Q.3

1. What is NDA? Explain in brief about content and format. (06)
2. What is CTD? Explain the modules of CTD. (05)

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3. Discuss the analytical validation guideline as per ICH. (05)

Q.4

1. What is CDSCO? Discuss guideline for form submission under it. (06)
2. Write note on inactive ingredient guidelines. (05)
3. Discuss registration of USFDA for new-drug approval process. (05)

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Q.5

1. What is SUPAC —IR? Discuss regarding post approval changes in SUPAC- IR. (06)
2. Discuss about component and composition of SUPAC —SS. (05)
3. Explain registration process of new drug under ANVISA. (05)

Q.6

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1. Define new drug according to FDA. Explain in detail the new drug development process with the time course for each phase. (06)
2. Enlist and explain different types of IND. (05)
3. What is MHRA? Discuss aim and objective of MHRA. (05)

Q.7

1. Discuss general requirement of NDA. Discuss in brief about provisions of supplement NDA. (06)

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2. What are Bio — Similar? How approval of bio-similar differes from NDA? (05)
3. Discuss regarding guideline for funding research and studies. (05)

Total Marks: 80

Date: 27-11-2019

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