Bioequivalence and Bioavailability Forum

Dear all,

As per this document (16 February 2012 EMA/618604/2008 Rev. 4 Committee for Human Medicinal Products (CHMP)) page no 6:

"3. MR formulations developed as generics
For generic products, the guideline recommends two single dose 2 way crossover studies evaluating test and reference fasted, and test and reference fed, respectively. Alternatively a single dose 4 way crossover study (MR generic fed and fasted + reference fed and fasted) can be conducted to demonstrate bioequivalence between generic and reference in both fasting and fed state. In a 4 way crossover study a comparison of the food effect for test and reference is possible, which will not be the case if two 2 way cross over studies are conducted, as between study comparison of food effect is not recommended."

Does this mean only Fasting and Fed is required for MR or we should follow NfG 1999 where Fasting fed and Steady state is recommended.

Any idea when will MR guideline BE studies be published?

Regards,

CHiku

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Edit: Q&A document linked. [Helmut]