Log in
RegisterTwo Stage Design for EMEA [Two-Stage / GS Designs]
Hi prashantmohite,
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.
❝ 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
Pass or fail!
ElMaestro
Complete thread:
- Two Stage Design for EMEA prashantmohite 2014-03-29 06:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
Ing. Helmut Schütz