FDA and outliers [Study As­sess­ment]

posted by mittyri – Russia, 2018-12-11 16:38 (607 d 13:45 ago) – Posting: # 19681
Views: 4,670

Dear Mann,

I don't think the position of FDA is different.
Please see this old post.

Do you have any experience of BEQ analysis for submission in FDA/EMA jurisdiction?
Where is the idea of outliers coming from?
Do the results without any outliers analysis also show not-BE?

Kind regards,
Mittyri

Complete thread:

Activity
 Admin contact
20,989 posts in 4,375 threads, 1,460 registered users;
online 9 (0 registered, 9 guests [including 3 identified bots]).
Forum time: Monday 07:23 CEST (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

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