Download Pharm D 5th Year 2017 Oct 383825 Clinical Research Question Paper

Download Pharm-D (Doctor of Pharmacy) 5th Year (Fifth Year) 2017 Oct 383825 Clinical Research Previous Question Paper

[LL 825] OCTOBER 2017 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. Define Clinical trials. Discuss in detail about the various phases involved in
Clinical trial and detail.

2. Discuss in detail about various approaches of Drug discovery.

3. Role and responsibilities of principal investigator in clinical trials.

4. Define Investigational New Drug Application (INDA) and discuss the components
and categories of INDA in detail.

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

1. Post marketing surveillance.
2. Write note on Schedule ? Y.
3. Safety monitoring in clinical trials.
4. Discuss in brief about different dosage forms.
5. Preparation of Informed Consent Form (ICF).
6. Role and responsibilities of data management team in clinical trials.


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