Download DNB 2019 Dec 2019 Dec PHARMACOLOGY PAPER IV Question Paper

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DECEMBER 2019

PHARMACOLOGY

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PAPER-IV

Time: 3 hours PHARM/D/19/34/1vV Max. Marks:100

Important Instructions:

• Attempt all questions in order.
• Each question carries 10 marks.

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• 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.

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• Draw table/diagrams/flowcharts wherever appropriate.

Write short notes on:

1. Give an outline about calculation of compensation if the trial participant suffers serious adverse event in a clinical trial. Add a note on the recommended time line of paying compensation by the sponsor after a trial related serious adverse event. (7+3)
2. Write briefly how you would help the sponsor to establish a BA-BE study Centre for regulatory BA-BE studies following newer rules in India. (7+3)
3. Describe with examples the mechanisms of action of siderophore antibiotics. How could these agents be used to overcome bacterial resistance? (7+3)

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4. Write in brief about recent advances in the treatment of rheumatoid arthritis. How can you prevent some of the adverse effects of biologics? (8+2)
5. Discuss briefly about the newer anticoagulants. What are their advantages and disadvantages compared to conventional anticoagulants? (6+4)
6. Write a brief note on ethical considerations on research involving bio banking. Give your comments on broad vis-a vis blanket consent for using human biomaterials. (6+4)
7. Enumerate the principles of research among vulnerable population according to recent changes in ethical guidelines in India. What are the protective mechanisms to safeguard their interest? (6+4)
8. Elaborate with examples the recent advances, future prospects and challenges of antisense oligonucleotide therapy. (6+2+2)

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9. Enumerate the essential and additional elements of informed consent documents according to recent Indian Guidelines. In which conditions Ethics Committee may grant waiver of consent? (7+3)
10. Give an outline of expedited drug approval pathways. Make a brief note on application of artificial intelligence in pharmacovigilance. (5+5)

POSSESSION/USE OF CELL PHONES OR ANY IS NOT PERMITTED INSIDE THE EXAMINATION HALL.