Helmut
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2007-06-17 23:56

Posting: # 814
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 EU: Concept Paper on BCS-based Biowaiver [Dissolution / BCS / IVIVC]

Dear all,

on 24 May 2007 EMEA published a 'Concept Paper on BCS-based Biowaiver'.

The deadline for comments (by international scientific societies related to bioavailability, bioequivalence, pharmacokinetics and in vitro dissolution) is 31 August 2007; comments should be provided to EWPSecretariat@emea.europa.eu (Fax +44 20 7418 86 13).

An overview is provided in the 'News Section'.

The document is available at the EMEA (43kB PDF).

Cheers,
Helmut Schütz
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