Download Pharm D 5th Year 2013 Oct 383825 Clinical Research Question Paper

Download Pharm-D (Doctor of Pharmacy) 5th Year (Fifth Year) 2013 Oct 383825 Clinical Research Previous Question Paper

[KD 825] OCTOBER 2013 Sub. Code: 3825
DOCTOR OF PHARMACY (PHARM. D / POST BACCALAUREATE)
DEGREE EXAMINATION
FIFTH YEAR
PAPER I ? CLINICAL RESEARCH
Q.P. Code: 383825
Time: Three Hours Maximum: 70 marks
Answer All questions
I. Elaborate on: (2 x 20 = 40)
1. What is ANDA?
What are the drugs come under ANDA?
What is meant by generic drugs?
Write a note on post marketing surveillance.
2. What is Institutional human ethical committee?
Give the composition, qualification required for the members.
Explain the functions of the committee.
II. Write notes on: (10 x 3 = 30)
1. Explain the importance of Pharmacological information in drug discovery.
2. Name various chemical characteristics of the drug.
3. Write a not on GCP.
4. What are the challenges faced by the investigator in clinical trials.
5. Write a not on schedule Y.
6. Explain the responsibility of the auditors in clinical trials.
7. Explain the protocol involved in data management in clinical research.
8. Differentiate Phase II & Phase III clinical trials.
9. Why randomization is important in clinical research?
10. Write the significance of preclinical testing in clinical research.
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