Download GTU (Gujarat Technological University Ahmedabad) B.Pharma (Bachelor of Pharmacy) 2019 Summer 7th Sem 2270010 Pharmacovigilance Previous Question Paper
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM - SEMESTER? 7 EXAMINATION ? SUMMER -2019
Subject Code: 2270010 Date: 20-05-2019
Subject Name: Pharmacovigilance
Time: 02:30 PM TO 05:30 PM
Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Discuss the contents and structure of Individual Case Safety Reports (ICSRs),
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(b) Write in brief about Phase-IV of clinical trials (Post-marketing surveillance).
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(c) Describe pattern and scale of counterfeiting.
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Q.2 (a) i. Explain: Thalidomide tragedy.
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ii. Differentiate between Adverse drug reaction and Adverse event.
(b) Write a note on adverse drug reactions of kidney.
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(c) Define SRS. Discuss potential and limitation of SRS.
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Q.3 (a) Define ADRs. Explain the types of ADRs with suitable examples.
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(b) Write role of pharmacist in the management of adverse drug reactions.
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(c) Write methods of detection of medication errors.
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Q.4 (a) Definition of substandard/spurious/falsely labelled/falsified/counterfeit
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medicines.
(b) Describe pharmacogenetic causes of ADRs.
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(c) Define Signal. Discuss sources and scope of signal detection.
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Q.5 (a) Write types of medication errors with examples.
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(b) Write a note on naranjo's casualtiy assessment scale.
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(c) Explain spontaneous reporting of adverse drug reactions with suitable
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examples.
Q. 6 (a) Write a note on pharmacovigilance in clinical trial
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(b) Write role ICSRs in Pharmacovigilance
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(c) Discuss forms and formats of SRS.
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Q.7 (a) Explain current methods of pharmacovigilance.
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(b) Write a note on pharmacovigilance regulation in india.
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(c) What are merits and demerits of spontaneous reporting?
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This post was last modified on 04 March 2021