B.PharmSemester 82022-23PharmacovigilanceBP805ET
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Pharmacovigilance (BP805ET) - AKTU Question Paper 2022-23

B.Pharm · Semester 8 · Free PDF Download

This is the official AKTU Pharmacovigilance 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

Pharmacovigilance (BP805ET) — 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
  • a
    Define the adverse drug reaction
  • b
    Compute the limitations of detecting ADRs in clinical trials
  • d
    Classify ADRs according to severity
  • e
    List out factors affecting adverse effects of the vaccine
  • f
    What is phase IV of clinical trials?
  • g
    What are CIOMS working groups?
  • h
    Discuss the cohort study with example. (i) Discuss the Defined daily doses. (j) Illustrate the importance of Pharmacogenomics
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
    Differentiate between adverse drug reactions and adverse events with suitable examples. Explain the mechanisms of Type-A and Type-B ADRs
  • b
    Illustrate the vaccine safety surveillance along with the diffe rent types of pharmacovigilance methods used for passive and active surveillance
  • c
    Explain the drug safety evaluation in pediatrics and geriatrics
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
    Characterize the different methods of causality and severity as sessment of ADRs and explain Naranjo’s scale
  • b
    Demonstrate the prereq uisite for setting up a pharmacovigilance c e n t e r i n a C R O a n d hospital
  • c
    Define vaccine. Explain reasons for vaccination failure
  • d
    Summarize the ATC classification of drugs with example
  • e
    Explore the Pre- marketing and Post-marketing clinical trials
  • f
    Illustrate the organization and objectives of ICH
  • g
    Explain the Schedule Y of Drugs and Cosmetics Act in brief

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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