B.PharmSemester 82022-23Pharmaceutical Regulatory ScienceBP804ET
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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) — complete question paper

Section AAttempt all q u e s t i o n s i n b r i e f . 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 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
  • a
    Discuss the various modules and r equirements of electronic Comm on 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 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
  • 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 and 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

Question text is extracted from the official AKTU question paper PDF above. Hindi translations are omitted — every question is printed in English in the original paper. Last verified: 2026-08-23.

Repeated Questions — BP804ET

Questions that appeared in more than one session, found by comparing 2 years of Pharmaceutical Regulatory Science papers (2021-22, 2022-23)

2x

What is the significance of pharmacovigilance?

Appeared in: 2021-22 · 2022-23

Pharmaceutical Regulatory Science — Other Year Papers

AKTU Pharmaceutical Regulatory Science PYQs from other sessions

Pharmaceutical Regulatory Science2021-22

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