Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
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[LF 825] OCTOBER 2014 Sub. Code: 3825
DOCTOR OF PHARMACY (PHARM. D/ POST BACCALAUREATE)
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DEGREE EXAMINATION
(2009-2010 Regulation)
FIFTH YEAR
PAPER I - CLINICAL RESEARCH
Q.P. Code: 383825
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Time: Three Hours Maximum: 70 marks
Answer All questions
- Elaborate on: (4 x 10 = 40)
- Define investigational new drug application and describe the components and categories of investigational new drug application.
- Discuss in detail the overview of the regulatory environment in Europe.
- Explain in detail the roles and responsibilities of regulatory authority and contract research coordinators.
- Describe in detail the various approaches to drug discovery.
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- Write notes on: (6 x 5 = 30)
- Write a short note on various phases of clinical trials.
- Describe briefly the ethical guidelines in clinical research.
- Write a note on data management and its components.
- Explain briefly the ICH guidelines.
- Write a note on the informed consent process.
- Post marketing surveillance.
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