EU Guideline on the Investigation of Bioequivalence (Rev. 1) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2008-08-05 04:15 (6520 d 21:24 ago) – Posting: # 2141
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Dear all,

now it's official: after 11 (!) internal draft versions of the EWP/PK group EMEA's 'Committee for Medicinal Products for Human Use' (CHMP) on its July plenary meeting adopted

CHMP/EWP/1401/98 Rev. 1 (Guideline on the Investigation of Bioequivalence)


for a six-month public consultation period (i.e., until 31 January 2009).
The document is expected to be published soon at EMEA's website.

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