Discuss the contents and structure of Individual Case Safety Reports (ICSRs),
[6 marks]Write in brief about Phase-IV of clinical trials (Post-marketing surveillance).
[5 marks]Describe pattern and scale of counterfeiting.
[5 marks]i. Explain: Thalidomide tragedy. ii. Differentiate between Adverse drug reaction and Adverse event.
[6 marks]Write a note on adverse drug reactions of kidney.
[5 marks]Define SRS. Discuss potential and limitation of SRS.
[5 marks]Define ADRs. Explain the types of ADRs with suitable examples.
[6 marks]Write role of pharmacist in the management of adverse drug reactions.
[5 marks]Write methods of detection of medication errors.
[5 marks]Definition of substandard/spurious/falsely labelled/falsified/counterfeit medicines.
[6 marks]Describe pharmacogenetic causes of ADRs.
[5 marks]Define Signal. Discuss sources and scope of signal detection.
[5 marks]Write types of medication errors with examples.
[6 marks]Write a note on naranjo’s casualtiy assessment scale.
[5 marks]Explain spontaneous reporting of adverse drug reactions with suitable examples. Q. 6 (a) Write a note on pharmacovigilance in clinical trial
[6 marks]Write role ICSRs in Pharmacovigilance
[5 marks]Discuss forms and formats of SRS.
[5 marks]Explain current methods of pharmacovigilance.
[6 marks]Write a note on pharmacovigilance regulation in india.
[5 marks]What are merits and demerits of spontaneous reporting?
[5 marks]