RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
30 Marks
- Write a note on clinical trial
pawwweolF ifspRanRexsedmstudies. FirstRanker.com - Explain the responsibilities of sponsors, CRO and investigator in ethical conduct of clinical research.
- Enumerate the application procedure for approval of NDA 505 (b) (1).
- Explain the principles of ICMR Ethical Guidelines for Biomedical Research
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Write a note on Phase 0 studies.
- Define and explain ethical principles of informed consent process.
- Write a note on role of placebo in clinical trials.
- Explain clinical trial protocol.
- Write a note on ANDA and its approval procedure.
- Explain regulatory requirements of BA/BE studies.
- Discuss on EU Directives 2001.
- Enumerate the Indian GCP guidelines.
- Write a note on 21 CFR Part 312 (IND Application)
- Add a note on FDA Med Watch. Explain about 21 CFR Part 822
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