Download DNB 2016 Dec PHARMACOLOGY PAPER 4 Question Paper

Download Diplomate of National Board (DNB) 2016 Dec PHARMACOLOGY PAPER 4 Previous Question Paper

FINAL EXAM NATIONAL BOARD OF EXAMINATIONS
DECEMBER 2016
POSSESSION / USE OF CELL PHONES OR ANY SUCH ELECTRONIC GADGETS IS NOT PERMITTED INSIDE THE
EXAMINATION HALL.
PHARMACOLOGY

PAPER ? IV
PHARM/D/16/34/IV
Time : 3 hours
Max. Marks : 100

Important instructions:

? Attempt all questions in order.
? Each question carries 10 marks.
? Read the question carefully and answer to the point neatly and legibly.
? Do not leave any blank pages between two answers.
? Indicate the question number correctly for the answer in the margin space.
? Answer all the parts of a single question together.
? Start the answer to a question on a fresh page or leave adequate space between two answers.
? Draw table/diagrams/flowcharts wherever appropriate.

Write short notes on:
1. a) What is a surrogate marker in a clinical trial?
b) What are their merits and demerits?

5+5
2. a) Role and responsibilities of DSMB in clinical trials.
b) Clinical trial registry of India ? Role and functioning.

5+5
3. a) Methods for causality assessment.
b) Timelines for reporting of serious adverse events in clinical
trials.

5+5
4. a) What are protocol violations in a clinical trial?
b) Guidelines for accredition of ethics committees in India.

5+5
5. a) Informed consent in clinical trials.
b) Ethical issues in clinical trials in vulnerable population.

5+5
6. a) Indications, limitations and advantages of therapeutic drug
monitoring.
b) Examples of drugs for which therapeutic drug monitoring is
recommended.

(4+2+2)+2
7. a) What are essential medicines?
b) National List of essential medicines.

4+6
8. a) Procedure and requirements for New Drug Application (NDA)
as per schedule in India.
b) Conditions where waiver of phase III clinical trial can be
considered.
c) Issues regarding compensation in clinical trial related injury.

4+3+3
9. a) Responsibilities of sponsor of a clinical trial as per the Indian
GCP guidelines.
b) Orphan drugs.

5+5
10. a) Biosimilars
b) Pharmacotherapy of Alzheimer?s disease.
5+5
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