Bioequivalence and Bioavailability Forum • Outliers?

Outliers? [BE/BA News]

posted by Helmut – Vienna, Austria, 2022-12-03 00:11 (502 d 22:14 ago) – Posting: # 23383
Views: 5,814

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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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- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
  - Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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
    - Webinar: Recording available Helmut 2023-04-01 10:38
  - Speed kills Helmut 2023-02-07 13:02