Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
[LL 825] OCTOBER 2017 Sub. Code: 3825
PHARM. ‘D’ AND PHARM. ‘D’ (POST BACCALAUREATE) DEGREE EXAMINATION
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(2009-2010 Regulation)
FIFTH YEAR
PAPER I - CLINICAL RESEARCH
Q.P. Code : 383825
Time : Three hours Maximum : 70 Marks
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- Elaborate on: (4 x 10 =40)
- Define Clinical trials. Discuss in detail about the various phases involved in Clinical trial and detail.
- Discuss in detail about various approaches of Drug discovery.
- Role and responsibilities of principal investigator in clinical trials.
- Define Investigational New Drug Application (INDA) and discuss the components and categories of INDA in detail.
- Write notes on: (6x5=30)
- Post marketing surveillance.
- Write note on Schedule — Y.
- Safety monitoring in clinical trials.
- Discuss in brief about different dosage forms.
- Preparation of Informed Consent Form (ICF).
- Role and responsibilities of data management team in clinical trials.
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