Download Pharm D 5th Year 2016 April 383825 Clinical Research Question Paper

Download Pharm-D (Doctor of Pharmacy) 5th Year (Fifth Year) 2016 April 383825 Clinical Research Previous Question Paper

[LI 825] APRIL 2016 Sub. Code: 3825

PHARM. ?D? AND PHARM. ?D? (POST BACCALAUREATE)
DEGREE EXAMINATION
(2009-2010 Regulation)
FIFTH YEAR
PAPER I ? CLINICAL RESEARCH

Q.P. Code : 383825
Time : Three hours Maximum : 70 Marks

I. Elaborate on: (4 x 10 = 40)

1. Explain the Pharmacological and Toxicological approaches to Drug discovery.

2. Describe the roles and responsibilities of Investigators and Clinical Research
associates.

3. Discuss the challenges in the implementation of Good Clinical Practice guidelines.

4. Describe the guidelines of Central drug standard control organization.

II. Write notes on: (6 x 5 = 30)

1. Abbreviated New Drug Application.
2. Various types of post marketing surveillance.
3. Ethical principles in Clinical research.
4. Explain the contents in Investigational new drug application.
5. Safety monitoring in Clinical research.
6. Responsibilities of Institutional review board.


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