Bioequivalence and Bioavailability Forum • SxF

SxF [BE/BA News]

posted by ElMaestro – Denmark, 2022-12-04 07:34 (65 d 18:39 ago) – Posting: # 23385
Views: 1,996

Hi all,

the new draft is interesting and I am still digesting it.

I see that the SxF interaction is given some consideration here, but I am not sure what is meant now. One thing is the outlier aspect and that is ok (Line 387 etc). But it enters the scene again in Line 478 and that part is not so clear. As you read it, do they recommend estimation of SxF whenever the design allows? What do we do with the info?

Muchas gracias.

—
Pass or fail!
ElMaestro

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
- SxFElMaestro 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- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
  - Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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
  - Speed kills Helmut 2023-02-07 13:02