Possible reasons for group effect [Design Issues]

posted by GM – India, 2019-07-23 08:23 (1532 d 01:52 ago) – Posting: # 20433
Views: 3,321

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:

UA Flag
Activity
 Admin contact
22,763 posts in 4,775 threads, 1,628 registered users;
13 visitors (0 registered, 13 guests [including 3 identified bots]).
Forum time: 10:15 CEST (Europe/Vienna)

The object of statistics is information.
The objective of statistics is the understanding of information
contained in data.    Irwin and Marylees Miller

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