Pharm D Last 12 Years 2010-2022 Question Papers (1st Year, 2nd Year, 3rd Year, 4th Year and 5th Year)
[KD 825] OCTOBER 2013 Sub. Code: 3825
DOCTOR OF PHARMACY (PHARM. D / POST BACCALAUREATE) DEGREE EXAMINATION
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FIFTH YEAR
PAPER I - CLINICAL RESEARCH O.P. Code: 383825
Time: Three Hours Maximum: 70 marks
Answer All questions
- Elaborate on: (2x20=40)
- What is ANDA? What are the drugs come under ANDA? What is meant by generic drugs?
- Write a note on post marketing surveillance. What is Institutional human ethical committee? Give the composition, qualification required for the members. Explain the functions of the committee.
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- Write notes on: (10x 3 =30)
- Explain the importance of Pharmacological information in drug discovery.
- Name various chemical characteristics of the drug.
- Write a not on GCP.
- What are the challenges faced by the investigator in clinical trials.
- Write a not on schedule Y.
- Explain the responsibility of the auditors in clinical trials.
- Explain the protocol involved in data management in clinical research.
- Differentiate Phase II & Phase III clinical trials.
- Why randomization is important in clinical research?
- Write the significance of preclinical testing in clinical research.
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