Bioequivalence and Bioavailability Forum

Dear all,

EMEA recently published a “Concept paper for an Addendum to the Note for Guidance on the Investigation of Bioavailability and Bioequivalence: Evaluation of Bioequivalence of Highly Variable Drugs and Drug Products”.

Scaled average bioequivalence (SABE) is under consideration.

The deadline for comments (by international scientific societies in statistics and in pharmacokinetics) is 31 July 2006; comments should be provided to monika.crotonemea.eu.int (Fax +44 20 7418 86 13).

Unfortunately the document (dated 27 April 2006) was distributed by EMEA’s mailserver on 23 May 2006, which cuts down the response time to just two months

The document is available at the EMEA (36kB PDF):
http://www.emea.eu.int/pdfs/human/ewp/14723106en.pdf.

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Edit: the document was removed from the EMEA’s website in October 2007. A copy is available at our site.