Pharmaceutical Regulatory Science (BP804ET) - AKTU Question Paper 2021-22
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 2021-22. 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:2021-22
University:AKTU / UPTU
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Questions Asked in 2021-22
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 . 10 x 2 = 20
- aDefine innovator drug product
- bMention the various modules of CTD format
- cEnumerate the GCP obligations of the investigators
- dDefine Pharmacovigilance
- eWhat is the significance of drug discovery?
- fWhat is purple book? Give its importance
- gMention the different stages of clinical trials
- hHow will you define generic products? i. Define non-clinical trials. j. What is the importance of informed consent form?
Section BAttempt any two p a r t s o f t h e f o l l o w i n g : 2 x 10 = 20
- aDescribe in detail the time lines involved in Investigational New Drug application
- bHow will you define drug master file? Discuss its significan ce in detail
- cDiscuss the development of clinical trial protocols in detail
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
- aDiscuss the drug developm ental process in detail
- bWrite a detailed note on regulat ory approval process of ANDA
- cExplain in detail the procedure for export of pharmaceutical products in India
- dWhat do you mean by orange book? Describe in detail
- eGive an overview of the regulatory authorities of India
- fGive the detailed process of generic drug product development
- gWhat is Institutional Review Board? Describeits formation and working procedures
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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