DNB 2016 Dec Previous Question Papers-(Diplomate of National Board) Under NBE
FINAL EXAM NATIONAL BOARD OF EXAMINATIONS
DECEMBER 2016
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PHARMACOLOGY
PAPER - IV
PHARM/D/16/34/IV
Time : 3 hours
Max. Marks : 100
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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.
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Write short notes on:
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- a) What is a surrogate marker in a clinical trial? 5+5 What are their merits and demerits?
- a) Role and responsibilities of DSMB in clinical trials. 5+5
- a) Clinical trial registry of India — Role and functioning.
- a) Methods for causality assessment. 5+5 b) Timelines for reporting of serious adverse events in clinical trials.
- a) What are protocol violations in a clinical trial? 5+5 b) Guidelines for accreditation of ethics committees in India.
- a) Informed consent in clinical trials. 5+5 b) Ethical issues in clinical trials in vulnerable population.
- a) Indications, limitations and advantages of therapeutic drug monitoring. (4+2+2)+2 b) Examples of drugs for which therapeutic drug monitoring is recommended.
- a) What are essential medicines? 4+6 b) National List of essential medicines.
- a) Procedure and requirements for New Drug Application (NDA) as per schedule in India. 4+3+3 b) Conditions where waiver of phase II clinical trial can be considered. c) Issues regarding compensation in clinical trial related injury.
- a) Responsibilities of sponsor of a clinical trial as per the Indian GCP guidelines. 5+5 b) Orphan drugs.
- a) Biosimilars 5+5 b) Pharmacotherapy of Alzheimer’s disease.
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POSSESSION / USE OF CELL PHONE IS NOT PERMITTED INSIDE THE EXAMINATION HALL.
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