B.PharmSemester 82021-22Pharmaceutical Regulatory ScienceBP804ET
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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) — complete question paper

Section AAttempt all q u e s t i o n s i n b r i e f . 10 x 2 = 20
  • a
    Define innovator drug product
  • b
    Mention the various modules of CTD format
  • c
    Enumerate the GCP obligations of the investigators
  • d
    Define Pharmacovigilance
  • e
    What is the significance of drug discovery?
  • f
    What is purple book? Give its importance
  • g
    Mention the different stages of clinical trials
  • h
    How 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
  • a
    Describe in detail the time lines involved in Investigational New Drug application
  • b
    How will you define drug master file? Discuss its significan ce in detail
  • c
    Discuss 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
  • a
    Discuss the drug developm ental process in detail
  • b
    Write a detailed note on regulat ory approval process of ANDA
  • c
    Explain in detail the procedure for export of pharmaceutical products in India
  • d
    What do you mean by orange book? Describe in detail
  • e
    Give an overview of the regulatory authorities of India
  • f
    Give the detailed process of generic drug product development
  • g
    What is Institutional Review Board? Describeits formation and working procedures

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 drug discovery?

Appeared in: 2021-22 · 2022-23

Pharmaceutical Regulatory Science — Other Year Papers

AKTU Pharmaceutical Regulatory Science PYQs from other sessions

Pharmaceutical Regulatory Science2022-23

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