FDA and outliers [Study As­sess­ment]

posted by mittyri – Russia, 2018-12-11 16:38 (1263 d 12:52 ago) – Posting: # 19681
Views: 6,667

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:

UA Flag
Activity
 Admin contact
22,110 posts in 4,630 threads, 1,567 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Saturday 06:31 CEST (Europe/Vienna)

We can teach from our experience,
but we cannot teach experience.    Sasha Azevedo

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