Possible reasons for group effect [Design Issues]

posted by GM – India, 2019-07-23 04:23 (584 d 00:05 ago) – Posting: # 20433
Views: 2,337

Hi Helmut and ElMaestro,

Thanks for reply. It helps me a lot.

I have seen one FDA BE review (see link) regarding group effect. Please see page 6 (Reviewer’s Comments) and page 52 (control document).

Here agency is asking for the BE of any one of the group, if group-by-treatment interaction is significant (p<0.05). Is it possible in studies conducted on HVD?

Please provide your thoughts on the same.

Best Regards,
GM

Complete thread:

Activity
 Admin contact
21,356 posts in 4,458 threads, 1,493 registered users;
online 13 (0 registered, 13 guests [including 1 identified bots]).
Forum time: Friday 04:28 UTC (Europe/Vienna)

Those who make no mistakes are making the biggest mistakes of all 
they are attempting nothing new.    Anthony de Mello

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5