Bioequivalence and Bioavailability Forum

Multi-group studies ad nauseam [BE/BA News]

posted by Achievwin – US, 2023-02-25 17:18 (1214 d 04:13 ago) – Posting: # 23475
Views: 17,106

❝ The FDA? Where?

Outlined in FDAs Statistical approaches for BE studies guidance in lines 516-544 clearly stats do your analysis on complete population (not to split hair on groups ). My experience group effect is critical when heterogenous ethnic population across multiple continents are recruited and contributing to disproportional variability and results skewing the final outcome.

Hope it churns more academic discussion and we MAY have some clarity before I retire.....

Complete thread:

• New guidance on Sta­tis­tical Approaches to Establishing Bio­equi­va­lence Relaxation 2022-12-02 15:53 
  • 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  • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
    • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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 nauseamAchievwin 2023-02-25 16:18
      • Webinar: Re­cord­ing avail­able Helmut 2023-04-01 10:38
    • Speed kills Helmut 2023-02-07 13:02