Download Pharm D 5th Year 2019 Oct 383825 Clinical Research Question Paper

Download Pharm-D (Doctor of Pharmacy) 5th Year (Fifth Year) 2019 Oct 383825 Clinical Research Previous Question Paper

[LP 825] OCTOBER 2019 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. Write about the ICH guidelines in clinical trials.
2. Describe the various pharmacological and toxicological approaches to drug
discovery.
3. Give an account on Abbreviated New drug Application.
4. Discuss the roles and responsibilities of sponsors and investigators in clinical
research.

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

1. Regulatory environment in India.
2. Vulnerable subjects.
3. Challenges in implementation of guidelines in clinical trials.
4. Responsibilities of clinical research coordinator in clinical research.
5. Case Report form in study design.
6. Significance of Post marketing surveillance.


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