Download OU Pharm D Question Paper 5th Sem 2018 1262 Clinical Research

Download OU (Osmania University) Pharm D (Doctor of Pharmacy) V Sem (5th Semester) 2018 1262 Clinical Research Previous Question Paper

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Code No. 1262
FACULTY OF PHARMACY
Pharm D (6?YDC) V-Year (Main & Backlog) Examination, July 2018
Subject: Clinical Research
Time: 3 Hrs Max.Marks: 70
Note: Answer all questions from Part ? A. Any Five questions from Part ? B.
PART ? A (10x2 = 20 Marks)
1 What is drug discovery? Write basic approaches to drug discovery.
2 Write note on registration of clinical trials.
3 Write different methods of lead identification.
4 List t varis functions of data management team.
5 What is periodic and interim review by EC?
6 What is waiver of consent in clinical research?
7 What is a target molecule? Write briefly the different approaches to target
identification.
8 What are different control treatments in clinical trial design?
9 Explain the responsibilities of monitor in clinical trials.
10 What are ?equivalence?, ?superiority? and ?non-inferiority? trials?
PART ? B (50 Marks)
11 Explain the term ?lead molecule?. Describe in detail the lead identification and
optimization process.
12 List t varis responsibilities of IRB. Explain review procedures of a research
proposal by IRB.
13 Explain post marketing surveillance methods.
14 Explain the components of clinical trial design.
15 Discuss varis animal pharmacology testing required for discovery of new drugs.
16 a) Give an overview of regulatory environment in USA.
b) Write detailed note on selection of special grps as research participants.
17 Explain the statement of general principles and specific principles for clinical
evaluation of drugs.
18 a) Explain data capture in CDM.
b) Write note on ICF and PIC.
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