Pharmaceutical Regulatory Science (BP804ET) - AKTU Question Paper 2022-23
B.Pharm · Semester 8 · Free PDF Download
This is the official AKTU Pharmaceutical Regulatory Science Previous Year Question Paper for B.Pharm Semester 8, academic session 2022-23. Published by Dr. A.P.J. Abdul Kalam Technical University (AKTU/UPTU), Lucknow. Free PDF download — no login required.
Course:B.Pharm
Semester:Semester 8
Session:2022-23
University:AKTU / UPTU
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Questions Asked in 2022-23
Pharmaceutical Regulatory Science (BP804ET) — extracted question text
Section AAttempt all q u e s t i o n s i n b r i e f . 2 x 10 = 20
- aDifferentiate NDA and ANDA
- bWhat is placebo trial?
- cWhat do you mean by a randomized design?
- dDefine clinical trial and explain Phase II
- eWrite about Timeline and types of IND
- fHow many people will be selected for Phase-I trial?
- gWhat is the significance of pharmacovigilance?
- hImportance of DMF. (i) Write a brief note on 21 CFR. (j) Differentiate Generic vs Innovator
Section BAttempt any two p a r t s o f t h e f o l l o w i n g : 10 x 2 = 20
- aDiscuss the various modules and r equirements of electronic Comm on Technical Document (eCTD)? Compare it with ASEAN common technical documents (ACTD)
- bWrite the various stages of Development of new drugs
- cDiscuss the application and approval process of ANDA
Section CAttempt any five p a r t s o f t h e f o l l o w i n g : 7 x 5 = 35
- aExplain organization structure and functions of USFDA
- bWhat are various GCP obligations of investigator and sponsor?
- cExplain the salient features of orange book and purple book
- dExplain the organization and functions of CDSCO
- eDiscuss the organization structure and functions of Australian drug regulatory body
- fExplain the safety monitoring in clinical trials
- gDiscuss the importance of pharmaceutical regulatory affairs in industry
Question text is extracted from the official AKTU question paper PDF above. Check the original PDF for equations, diagrams and complete wording. Extracted: 2026-08-23.
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