Outliers? [BE/BA News]

posted by mittyri  – Russia, 2022-12-02 23:52 (956 d 09:15 ago) – Posting: # 23382
Views: 13,602

Hi Helmut,

❝ Three options.

  1. Hire a consultant with a SAS license.

  2. AFAIK, the FDA recalculates all studies. Cross fingers.

  3. Wait till someone publishes a paper about cross-validation. ;-)

I'll cross fingers to have that omitted from the final guidance (even if I do not plan to submit to FDA anything:-D; FDA guidelines are getting used to penetrate across the world).

❝ As an aside:

How to assess ‘outliers’ in RSABE?

the only one method I can recall is described by Mr.Schall with coauthors
But I know that your question is not trivial and deeper than that.

PS: what is wrong with the format of cited list?

Kind regards,
Mittyri

Complete thread:

UA Flag
Activity
 Admin contact
23,436 posts in 4,932 threads, 1,673 registered users;
62 visitors (0 registered, 62 guests [including 9 identified bots]).
Forum time: 10:08 CEST (Europe/Vienna)

You are rewarding a teacher poorly
if you remain always a pupil.    Friedrich Nietzsche

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