Bioequivalence and Bioavailability Forum

In the reflection of revised CPMP/EWP/QWP/1401/98 guideline (Rev. 1/Corr*), I would appreciate your opinion on the case when bioequivalence is demonstrated in 12 subjects in Pilot BE Study and the stop criterion is specified in the Study Protocol prospectively.
I suppose, that the status remains the same as it was presented on this Forum 2006-08-16 12:44 by Helmut (#218 BE demonstrated in pilot study). i.e.:

❝ It should be possible to claim BE with a pilot study, if

❝ 1.your sample size is at least the minimum required in the legislation you

❝ are bound to (e.g., 12 for WHO, EU, USA [?] CAN, NZ, AUS, Malaysia, Argentina,

❝ ASEAN States, RSA [20 for MR products]; 24 for Brazil), and

❝ 2.you have stated such a 'stop criterium' in your study protocol.

What is your current view?

Many thanks.

Best regards,
Jana