The EMA’s BSWP’s opinon [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2016-03-04 23:16 (2151 d 04:23 ago) – Posting: # 16052
Views: 8,735

Hi Hötzi,

clearly there must be some kind of misunderstanding. Some of the Spandinavians are not easy to understand as recent linguistic research has proven.

I have ok experience with scientific advices at EU agencies; as far as I recall I did not once run into someone telling me that an approach wasn't acceptable, as long as it was backed well up with a simulation to control type I errors. Regulators have for several years now accepted two-stage approaches (see e.g. the Q&A you linked to) and as far as I know Potvin's papers and its descendants are the only ones containing anything that just remotely resembles a proof of control over the type I error. But ok, perhaps regulators have a secret method which is acceptable (as long as there is a period in stage term :-D:-D:-D) and which they forgot to share with the rest of the world. I can't tell if this is the case, but I somehow doubt it. Is the problem simulation rather than math proof? It isn't my impression that simulations are outright banned or discouraged and some members of the PKWP or BSWP have published enjoyable and useful science based on simulation. Some of them have even been active in research funded under EU's 7th frame programme - it was called "Biosim" and the whole idea of simulation was enthusiastically promoted as being scientifically sound and necessary from many angles and it even enjoyed regulatory support from regulators in AT, NL, ES, DE, FR, NO and possibly UK not sure?!. The countries are just from the top of my head.


Yah I read that one too. I have a copy in the loo, might come in handy if I one day run out of roll.

Pass or fail!

Complete thread:

 Admin contact
21,844 posts in 4,571 threads, 1,555 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Monday 03:39 CET (Europe/Vienna)

Do, or do not.
There is no ‘try’.    Yoda

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz