[india-drug] Response to Ethics of Clinical Trials

[usha gupta <usha_gupta2@yahoo.com>]

Response to Ethics of Clinical Trials 
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Lakhvinder,

I am responding to your query. In general, you cannot include children
and pregnant women in Phase I and Phase II studies of a new drug. For
more details you must get a copy of "Good Clinical Practices" giving
guidelines for clinical trials on pharmaceutical products in India
published by Ministry of Health & Family Welfare, Government of India.
This will also give other details of Phase I and Phase II studies
besides single dose and multi-dose kinetic studies.

Best wishes,

Dr Usha Gupta,
Professor & Head,
Pharmacology Department,
Maulana Azad Medical College, 
New Delhi 110 002. India.



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