[india-drug] Ethics of clinical trials

[Edrug <e-drug@healthnet.org>]

(Copied From Edrug. Thanks?SS)

E-drug: Ethics of clinical trials
                 
---------------------------------------------------------------------
I am working in the field of drug development, conducting clinical
trials from Phase 1 through Phase 3. I am working on a protocol of
developing antimalarials and would like feedback from people with an
insight in drug development, especially in the field of ethics.

I wonder whether it is OK (pardon the layman usage) to conduct
pharmacokinetics (PK) studies of antimalarials in pregnant females and
in children. I know it happens, but exactly at what stage of drug
development is this carried out (late Phase 1 or Phase 2)? What are 
the additional studies apart from single dose and multiple dose 
studies to be conducted as Phase 1 or early phase 2?

Regards,

Lakhvinder S. Batolar
Research Scientist,
Clinical Development Services
INDIA
tel: +91-9891364617
e-mail: lakhvinder@email.com


________________________________________________________________________
Yahoo! India Matrimony: Find your partner online.
Go to http://yahoo.shaadi.com

Access Essential Drugs Monitor #32 at http://www.who.int/medicines/mon/mon32.shtml

The INDIA-DRUG discussion group is a partnership between SATELLIFE
(www.healthnet.org), WHO Essential Drugs and Medicines Policy
(www.who.ch), and the Delhi Society for the Promotion of the
Rational Use of Drugs (DSPRUD) in India.

To send a message to india-drug, write to: india-drug@healthnet.org
To subscribe or unsubscribe, write to: majordomo@healthnet.org
in the body of the message type: subscribe india-drug OR unsubscribe india-drug
To contact a person, send a message to: india-drug-help@healthnet.org