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Paper Id:  231064                                            Roll No.          
 

B PHARM
(SEM VIII) THEORY EXAMINATION 2022-23

PHARMACEUTICAL REGULATORY SCIENCE
Time: 3 Hours        Total Marks: 75
Note:  Attempt all Sections. 
 

SECTION A

1. Attempt all questions in brief.      2 x 10 = 20
(a) Differentiate NDA and ANDA.

(b) What is placebo trial?

(c) What do you mean by a randomized design?

(d) Define clinical trial and explain Phase II.

(e) Write about Timeline and types of IND.

(f) How many people will be selected for Phase-I trial?

(g) What is the significance of pharmacovigilance?

(h) Importance of DMF.

(i) Write a brief note on 21 CFR.

(j) Differentiate Generic vs Innovator.

SECTION B

2. Attempt any two parts of the following:     10 x 2 = 20
(a) Discuss the various mQP23

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odules and requirements of electronic Common Technical
Document (eCTD)? Compare it with ASEAN common technical documents (ACTD).

(b) Write the various stages of Development of new drugs.

(c) Discuss the application and approval process of ANDA.

 
SECTION C

3. Attempt any five parts of the following:     7 x 5 = 35
(a) Explain organization structure and functions of USFDA.

(b) What are various GCP obligations of investigator and sponsor?

(c) Explain the salient features of orange book and purple book.

(d) Explain the organization an |d 0
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 functions of CDSCO.

(e) Discuss the organization structure and functions of Australian drug regulatory body.

(f) Explain the safety monitoring in clinical trials.

(g) Discuss the importance of pharmaceutical regulatory affairs in industry.

QP23DP1_290   | 06-01-2023 13:34:49 | 117.55.242.132