Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
[KX 825] SEPTEMBER 2010 Sub. Code: 3825
DOCTOR OF PHARMACY (PHARM. D / POST BACCALAUREATE) DEGREE EXAMINATION
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(Regulations 2008-2009 )
(Candidates admitted from 2008-2009 onwards)
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: (2x20=40)
- Define Clinical Trials? Discuss in detail five various phases involved in drug development process.
- Discuss the composition, responsibilities and procedures of IRB/IEC.
- Write notes on: (6x5=30)
- Significance of post marketing surveillance.
- Roles and responsibilities of Investigators.
- Study designs in a clinical trail.
- Informed consent process.
- ICH guidelines in clinical trials.
- Purposes of an audit in a clinical trial.
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