Bioequivalence and Bioavailability Forum • A first look

A first look [BE/BA News]

posted by PharmCat – Russia, 2022-12-21 20:30 (657 d 12:12 ago) – Posting: # 23405
Views: 7,182

Hi all!

❝ ’In the Random statement, TYPE=FA0(2) could possibly be replaced by TYPE=CSH or UNR.’ THX for CSH. Why not TYPE=FA0(1)?

❝ Instead of Satterthwaite’s degrees of freedom Kenward-Roger could be used (what does ‘possibly’ mean here?)

Well it finally happened. It took 20 years to find out that FA0(2), CSH and UN is the same for this model for 2 formulations (but `possibly` means that not entirely sured about this). May be `possibly` means that in is not true for 3 formulation?

I don't understand what FA0(1) means for this model? No correlation? Same as diagonal cov structure?

❝ Alternative software could also be used if same results are generated as in PROC MIXED in SAS.

It is very funny. Because if percept it exactly - there is no software that give you exactly same DDoF (Satterthwaite’s or freedom Kenward-Roger). All of them (SPSS, WinNonlin ets...) give you slightly different results for DDoF.

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- Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence SMA 2023-02-06 09:07
  - Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Achievwin 2023-02-07 07:13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