Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
PHARM. ‘D’ AND PHARM. ‘D’ (POST BACCALAUREATE) DEGREE EXAMINATION (2009-2010 Regulation) FIFTH YEAR PAPER I - CLINICAL RESEARCH
Time : Three hours Maximum : 70 Marks
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I. Elaborate on: (4 x 10 =40)
- Explain the Pharmacological and Toxicological approaches to Drug discovery.
- Describe the roles and responsibilities of Investigators and Clinical Research associates.
- Discuss the challenges in the implementation of Good Clinical Practice guidelines.
- Describe the guidelines of Central drug standard control organization.
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II. Write notes on: (6x5=30)
- Abbreviated New Drug Application.
- Various types of post marketing surveillance.
- Ethical principles in Clinical research.
- Explain the contents in Investigational new drug application.
- Safety monitoring in Clinical research.
- Responsibilities of Institutional review board.
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