JNTUK B.Pharm 1-1 2020 Feb Previous Question Paper
FIFTH YEAR (2009-2010 Regulation)
PAPER I - CLINICAL RESEARCH
O.P. Code : 383825
Time : Three hours Maximum : 70 Marks
[PHARMD 0321] MARCH 2021 Sub. Code: 3825
(OCTOBER 2020 EXAM SESSION)
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PHARM. ‘D’ (POST BACCALAUREATE) DEGREE EXAMINATIONFIFTH YEAR (2009-2010 Regulation)
PAPER I - CLINICAL RESEARCH
O.P. Code : 383825
Time : Three hours Maximum : 70 Marks
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I. Elaborate on: (4 x 10 =40)
- Explain the Pharmacological and Toxicological approaches to Drug discovery.
- Define Investigator’s brochure and describe about its components.
- What are dosage forms? Give example. Explain different type of dosage forms.
- Explain Bias and discuss in detail about various sources of bias and methods to avoid Bias.
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II. Write notes on: (6x5=30)
- How SOPs are prepared to meet the Good Laboratory Practices standards?
- Write the ethical consideration in the conduct of Clinical trials.
- Write the safety issues on the investigational new drugs.
- What are the major challenges observed in implementation of the regulatory guidelines in clinical trials?
- Write a note on schedule Y.
- What is Randomization? Brief about static and adaptive designs.
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