Download Pharm D 5th Year 2014 Oct 383825 Clinical Research Question Paper

Download Pharm-D (Doctor of Pharmacy) 5th Year (Fifth Year) 2014 Oct 383825 Clinical Research Previous Question Paper

[LF 825] OCTOBER 2014 Sub. Code: 3825
DOCTOR OF PHARMACY (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
Answer All questions
I. Elaborate on: (4 x 10 = 40)
1. Define investigational new drug application and describes the component
and categories of investigational new drug application.
2. Discuss in detail the overview of regulatory environment in Europe.
3. Explain in detail the roles and responsibilities of regulatory authority and contract
research coordinators.
4. Describe in detail the various approaches to drug discovery.
II. Write notes on: (6 x 5 = 30)
1. Write short note on various phases of clinical trials.
2. Describe briefly the ethical guidelines in clinical research.
3. Write a note on data management and its components.
4. Explain briefly the ICH guidelines.
5. Write note on informed consent process.
6. Post marketing surveillance.

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