RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Discuss Regulatory requirements for ANDA approval. FirstRanker.com
- Explain the In vitro drug product performance and its limitations.
- Describe the regulatory guidelines for approval of biologics.
- Discuss development of clinical trial protocol and add a note on working of institutional review board for clinical trials.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- What are the amendments of Hatch - Waxman Act?
- Discuss the importance of informed consent in clinical trial.
- Discuss ICH guidelines related to maintenance.
- Write a note on Master formula record and distribution records.
- Discuss the regulatory requirements of investigator brochure.
- Explain non clinical development related to global submission of NDA.
- Discuss about CMC in regulations.
- Explain the Regulatory requirements of ROW countries.
- Write a note on post approval regulatory affairs.
- Discuss regulation of combination products.
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