[e-drug] Ethics of clinical trials

[Lakhvinder Singh Batolar <lakhvinder@email.com>]

E-drug: Ethics of clinical trials
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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

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