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

Download JNTUH (Jawaharlal Nehru Technological University Hyderabad) Pharm-D (Doctor of Pharmacy) 5th Year PD501 Clinical Research Previous Question Paper

Code No: PD501
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
Pharm.D V Year Supplementary Examinations, October - 2019
CLINICAL RESEARCH
Time: 3hours Max.Marks:70
Answer any five questions
All questions carry equal marks
- - -

1. Describe the following approaches for the drug discovery process:
a) Drug characterization
b) Dosage form. [7+7]

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

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

5. Describe the following:
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
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]

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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