Bioequivalence and Bioavailability Forum

SAS strikes back [BE/BA News]

posted by Achievwin – US, 2023-02-07 08:23 (711 d 12:12 ago) – Posting: # 23442
Views: 6,668

SAS strikes back is a misnomer. on multiple occasions I was told you are free to use whatever the software you want to use, agency will carry out their own analysis and if your values are matching with their analysis (not too far variation - you don't have match exactly to 6th decimal point with SAS,,,,

In case of doubt the agency will ask for 1) dataset used, 2) macro with 3) ease of use instructions. If you are using SAS or SPSS, or R, or Phoenix we should be good as ageny scientists are equally proficient in these programs.

Being an enthusiast I always did a mini validation across standard and alternate software under a pre-defined validation protocol, this was my ace whenever there is a question (not having any validation is crime - having some validation you may get slap on the wrist)

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  • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
    • Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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