Download JNTUH Pharm D 5th Year PD501 Clinical Research Question Paper

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Answer any five questions
All questions carry equal marks
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1. Describe the following approaches for the drug discovery process:

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a) Drug characterization
b) Dosage form. [7+7]

2. Describe the importance of the following in Drug Development process:
a) Pharmacological

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b) IND application. [7+7]

3.a) What are the different phases of clinical trials. Explain in detail.
b) Write about CDSCO guidelines. [7+7]

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4. Write about the following:
a) Methods of post marketing surveillance
b) Challenges in the implementation of guidelines. [7+7]

5. Describe the following:

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a) Overview of regulatory environment in Europe.
b) Composition, responsibilities and procedures of IEC [7+7]

6. Describe the responsibilities of the following personnel as per ICH GCP:
a) Sponsor

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b) Investigators [7+7]

7.a) Describe the protocol involved in the Abbreviated NDA submission.
b) Write about designing of clinical study documents. [7+7]

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8.a) Discuss the overview on Ethical guidelines in Clinical Research.
b) Write about the Safety monitoring in clinical trials. [7+7]

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