EMEA: Questions & Answers: Positions on specific questions addressed to the EWP therapeutic
31.07.2009
In the context of assessment procedures, the Therapeutic Subgroup on Pharmacokinetics of the
Efficacy Working Party (EWP-PK subgroup) is occasionally consulted by the CHMP or, following
CHMP’s agreement, by other Committees, Working parties or the CMD(h). The objective is to
address specific questions in relation to pharmacokinetic evaluations and particularly the requirements
and assessment of bioequivalence studies. The positions, which are being elaborated by the EWP-PK
subgroup in response to such questions, are being forwarded to the enquiring party for consideration in
their assessment.
The source of the news: http://www.emea.europa.eu/pdfs/human/ewp/61860408en.pdf
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