Bioequivalence and Bioavailability Forum

New guidance on Sta­tis­tical Approaches to Establishing Bio­equi­va­lence [BE/BA News]

posted by Relaxation  – Germany, 2022-12-02 16:53 (502 d 18:42 ago) – Posting: # 23376
Views: 6,510

Good afternoon everybody.

Although I assume that most of us have subscribed to the FDA newsletter, I wanted to post that FDA just notified that the new "Statistical Approaches to Establishing Bioequivalence" was made available.
From a quick once over interesting topics included .

Direct link to guidance page, not the download

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Edit: Changed to the download page because your link triggered a spam-filter. [Helmut]

Complete thread:

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  • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
    • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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