Posting: # 814
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).
The quality of responses received is directly proportional to the quality of the question asked. ☼