Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
OCTOBER 2019 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)
- Write about the ICH guidelines in clinical trials.
- Describe the various pharmacological and toxicological approaches to drug discovery.
- Give an account on Abbreviated New drug Application.
- Discuss the roles and responsibilities of sponsors and investigators in clinical research.
- Write notes on: (6x5=30)
- Regulatory environment in India.
- Vulnerable subjects.
- Challenges in implementation of guidelines in clinical trials.
- Responsibilities of clinical research coordinator in clinical research.
- Case Report form in study design.
- Significance of Post marketing surveillance.
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