Outliers? [BE/BA News]

posted by mittyri – Russia, 2022-12-02 23:52 (501 d 16:28 ago) – Posting: # 23382
Views: 5,782

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

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