Bioequivalence and Bioavailability Forum

Outliers? [BE/BA News]

posted by mittyri – Russia, 2022-12-02 23:52 (108 d 02:47 ago) – Posting: # 23382
Views: 2,880

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; 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?

Complete thread:

• New guidance on Sta­tis­tical Approaches to Establishing Bio­equi­va­lence Relaxation 2022-12-02 15:53 [BE/BA News] 
  • A first look Helmut 2022-12-02 16:43
    • A first look jag009 2022-12-02 17:58
      • A first look BRB 2022-12-02 18:20
    • SAS strikes back mittyri 2022-12-02 20:38
      • SAS strikes back Helmut 2022-12-02 22:30
        • Outliers?mittyri 2022-12-02 22:52
          • Outliers? Helmut 2022-12-02 23:11
        • SAS strikes back Achievwin 2023-02-07 07:23
    • model-based BE? mittyri 2022-12-07 16:26
      • model-based BE? Helmut 2022-12-10 10:13
        • Hooker, Moellenhoff et al. are moving MBBE forward mittyri 2023-01-11 15:32
        • model-based BE? SMA 2023-01-17 09:41
    • A first look PharmCat 2022-12-21 19:30
    • A first look Rayhope 2023-01-06 06:56
  • Groups, sites… Helmut 2022-12-03 13:09
  • SxF ElMaestro 2022-12-04 06:34
    • SxF Helmut 2022-12-10 10:37
  • New guidance on Sta­tis­tical Approaches to Establishing Bio­equi­va­lence Mahmoud 2022-12-10 14:08
  • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
    • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13
      • Multi-group studies ad nauseam Helmut 2023-02-07 11:30
        • Multi-group studies ad nauseam Achievwin 2023-02-25 16:18
    • Speed kills Helmut 2023-02-07 13:02