Possible reasons for group effect [Design Issues]

posted by GM – India, 2019-07-23 06:23  – Posting: # 20433
Views: 1,697

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
20,793 posts in 4,353 threads, 1,445 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: 12:24 CEST (Europe/Vienna)

In God we trust;
all others must bring data.    W. Edwards Deming

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