Seat No.:
Subject Code: 2270010
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Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM - SEMESTER- 7 EXAMINATION - SUMMER -2019
Subject Name: Pharmacovigilance
Time: 02:30 PM TO 05:30 PM
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Instructions:
- Attempt any five questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
- (a) Discuss the contents and structure of Individual Case Safety Reports (ICSRs). 06
- (b) Write in brief about Phase-IV of clinical trials (Post-marketing surveillance). 05
- (c) Describe pattern and scale of counterfeiting. 05
- (a) i. Explain: Thalidomide tragedy. 06
- (b) ii. Differentiate between Adverse drug reaction and Adverse event. 05
- (c) Write a note on adverse drug reactions of kidney. 05
- (a) Define SRS. Discuss potential and limitation of SRS. 06
- (b) Define ADRs. Explain the types of ADRs with suitable examples. 05
- (c) Write role of pharmacist in the management of adverse drug reactions. 05
- (a) Write methods of detection of medication errors. 06
- (b) Definition of substandard/spurious/falsely labelled/falsified/counterfeit medicines. 05
- (c) Describe pharmacogenetic causes of ADRs. 05
- (a) Define Signal. Discuss sources and scope of signal detection. 06
- (b) Write types of medication errors with examples. 05
- (c) Write a note on naranjo’s causality assessment scale. 05
- (a) Explain spontaneous reporting of adverse drug reactions with suitable examples. 06
- (b) Write a note on pharmacovigilance in clinical trial. 05
- (c) Write role ICSRs in Pharmacovigilance. 05
- (a) Discuss forms and formats of SRS. 06
- (b) Explain current methods of pharmacovigilance. 05
- (c) Write a note on pharmacovigilance regulation in india. 05
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What are merits and demerits of spontaneous reporting?
Total Marks: 80
Date: 20-05-2019
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