Outliers? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-12-03 00:11 (184 d 01:55 ago) – Posting: # 23383
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Hi Mittyri,

❝ 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).

Somebody at the FDA might have pushed the panic button. Behind the curtains possibly GBHI and ICH M13 are driving forces. Harmonization comes at a price.

❝ ❝ 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.

Yep. At least the EMA considered Schall et al. as too ‘statistical’ [sic] and recommended my joke of box plots. Not the slightest idea what the FDA expects.

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

As it ever was. Sorry. Christian Seiler’s PHP StringParser class is of 2008 and can’t handle lists properly. The only other I found is not compatible with PHP ≥7.0…

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