Underrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2020-03-11 15:24 (362 d 16:02 ago) – Posting: # 21252
Views: 3,577


it sounds like random flutter or a gender x treatment interaction? It could also be that the females increase variance, and this, I think, may be somewhat more likely.
Please show the data. Can you send us the STDM and ADAM datasets? :-D

» Can we conduct the pivotal study only in Males? Can we extrapolate the conclusions obtained in males to females. What would be the regulatory challenges and please prove some references that can guide me on this.

There are no directly relevant references. Generally speaking the innovator industry has been exploring lots and lots of opportunity for claiming population x treatment interactions, but it has so far been without much evidence.
Yes, you can likely conduct the study in males. But why would you if you think the conclusion in males can be extrapolated.

Pass or fail!

Complete thread:

 Admin contact
21,372 posts in 4,463 threads, 1,496 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Tuesday 07:27 CET (Europe/Vienna)

We learn more by looking for the answer to a question and not finding it
than we do from learning the answer itself.    Lloyd Alexander

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