Rajiv Gandhi University of Health Sciences, Karnataka
V Year Pharma-D (Post Baccalaureate) Degree Examination – Jan 2014
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Time: Three Hours Max. Marks: 70 Marks
CLINICAL RESEARCH
Q.P. CODE: 2874
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
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LONG ESSAYS (Answer any two) 2 x 10 = 20 Marks
- Explain the toxicological approach to drug development process
- Explain in detail the informed consent process
- Discuss data management and it's components
SHORT ESSAYS (Answer any six) 6 x 5 = 30 Marks
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- Write a note on case control studies
- What are the different regulatory systems in USA, EUROPE and INDIA
- Explain parenteral dosage forms in drug development process
- Write a note on GCP guidelines
- Write a note on Abbreviated New Drug Application
- Methods of Post marketing surveillance
- Explain the inclusion and exclusion criteria for clinical research
- Explain the responsibilities of IRB
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SHORT ANSWERS 10 x 2 = 20 Marks
- Drug control general of India
- European clinical directive
- Phase III
- Single blind method
- Contract research coordinators
- Investigator selection
- Chronic toxicity
- Case report form
- Role of auditor
- Mutagenicity and carcinogenicity.
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This download link is referred from the post: RGUHS Pharma-D Last 10 Years 2011-2021 Previous Question Papers || Rajiv Gandhi University of Health Sciences
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