Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
[LM 825] MAY 2018 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
O.P. Code : 383825
Time : Three hours Maximum : 70 Marks
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I. Elaborate on: (4 x 10 =40)
- Define Bias. Discuss in detail about various sources of bias and methods to avoid Bias.
- Describe in detail about regulatory setup that governs the clinical research process in India.
- Explain the components of clinical research protocol and the process of protocol preparation.
- Discuss in detail about various methods used in post marketing safety monitoring process.
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II. Write notes on: (6x5=30)
- Write a note on general parameters involved in inclusion and exclusion criteria.
- Write the responsibilities of sponsor’s in clinical trial.
- Write the functions of data and safety monitoring board.
- Define IND application and write contents of IND application.
- Write a short note on drug discovery process.
- Write the safety issues on the investigational new drugs.
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