Bioequivalence and Bioavailability Forum

SxF [BE/BA News]

posted by Helmut  – Vienna, Austria, 2022-12-10 11:37 (935 d 18:17 ago) – Posting: # 23398
Views: 13,213

Hi ElMaestro,

❝ I see that the SxF interaction is given some consideration here, but […] it enters the scene […] in Line 478 and that part is not so clear. As you read it, do they recommend estimation of SxF whenever the design allows?

If we follow the recommended mixed-effects model (lines 1068–1096), yes.

❝ What do we do with the info?

Attach the software’s output to the report.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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
    • SxFHelmut 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  • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
    • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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