Download OU Pharm D Question Paper 5th Sem 2019 13299 Clinical Research

FirstRanker.com

Firstranker's choice FirstRanker.com

Code No. 13299

--- Content provided by‌ FirstRanker.com ---

FACULTY OF PHARMACY

Pharm D (6 - YDC) V - Year (Main & Backlog) Examination, June 2019

Subject: Clinical Research

Time: 3 Hrs Max.Marks: 70

Note: Answer all questions from Part — A. Any Five questions from Part - B.

--- Content provided by​ FirstRanker.com ---

PART - A (10x2 = 20 Marks)

1. What is drug development? What are the steps involved in the process?
2. Write different methods of lead identification.
3. List the key players in clinical drug development.
4. What is NDA? How is it filed as per guidelines of schedule Y?

--- Content provided by‌ FirstRanker.com ---

5. What is waiver of consent in clinical research?
6. What is IEC? Write the composition and basic responsibilities of IEC.
7. What is Regulatory Authority? Write the general roles and responsibilities of Regulatory Authority.
8. Write advantages of electronic data capture in CDM.
9. Explain the responsibilities of monitor in clinical trials.

--- Content provided by​ FirstRanker.com ---

10. What are the types of control treatments in Phase II of clinical trials?

PART - B (5x10 = 50 Marks)

1. Explain the types of preclinical studies with regulatory requirements for conduct of studies. Discuss various animal pharmacology testing required for discovery of new drugs.
2. What is INDA? Explain the review process of IND application.
3. Explain various elements of clinical trial study design.

--- Content provided by⁠ FirstRanker.com ---

4. Explain in detail the different methods of post marketing surveillance.
5. Give an overview of regulatory environment in Europe.
6. What is ICMR code? Explain the statement of specific principles for drug trials.
7. a) Explain various data entry methods.
   b) Write note on CRF design.

--- Content provided by‍ FirstRanker.com ---

8. a) Explain various aspects of safety monitoring in clinical trials.
   b) Write note on quality assurance in CDM.

*kkk