Bioequivalence and Bioavailability Forum • Two Stage Design for EMEA

Two Stage Design for EMEA [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2014-03-29 20:10 (4062 d 22:53 ago) – Posting: # 12740
Views: 4,908

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.

—
Pass or fail!
ElMaestro

Complete thread:

Two Stage Design for EMEA prashantmohite 2014-03-29 06:39
- Two Stage Design for EMEAElMaestro 2014-03-29 19:10
- Two Stage Design for EMA [sic] Helmut 2014-03-31 00:35
  - Two Stage Design for EMA [sic] prashantmohite 2014-04-01 06:20