Bioequivalence and Bioavailability Forum

Hi prashantmohite,

❝ I have learnt that potvin B method has been accepted by FDA. Can anybody suggest me in designing a two stage approach or similar kind of approach for EMEA submission.

I think it is method C (at least) for FDA.

Anyways, I have ok experience with either B or C in EU in the sense that they accepted both in scientific advices I've had. But I would take a sc.advice at an agency, if I were you, to be sure.

Hi Prashant,

❝ I have learnt that potvin B method has been accepted by FDA.

Who told you that? Slides 20–23 of Barbara’s presentation*

❝ Can anybody suggest me in designing a two stage approach or similar kind of approach for EMEA submission.

I succeeded with both Methods B and C – though EMA seems to prefer variants of Method B (α-adjust­ment in both stages). For some obstacles see the Forum’s category Two-stage Designs.

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• BM Davit
  Sequential Designs and Interim Analyses in Bioequivalence: FDA’s Experience
  Mini-Symposium on Adaptive Study Designs and Assessment Approaches for Bioequivalence
  AAPS Annual Meeting, Chicago, IL, October 13–18, 2012