Bioequivalence and Bioavailability Forum • EMA BE-GL: Clarifications / Corrections?

EMA BE-GL: Clarifications / Corrections? [BE/BA News]

posted by Helmut – Vienna, Austria, 2010-06-22 20:53 (5048 d 16:13 ago) – Posting: # 5551
Views: 38,232

Dear all,

according to rumours at the recent Workshop in Budapest (235 participants!) EMA started an initiative involving the PK-Drafting Group and the Biostatistics Drafting Group of EWP to clarify/correct some open issues of the new BE-GL.
Points under discussion are

“Only fixed effects ANOVA” in replicate designs. RMLE under consideration.
Outliers. MAD of R-R will be an option.
The “T-R₁-R₂” issue.

We can expect not only SAS-code, but example data-sets in order to validate other software.

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

EMA BE-GL: Clarifications / Corrections?Helmut 2010-06-22 18:53 [BE/BA News]
- Good news!? d_labes 2010-06-23 10:09
  - Good news!? Helmut 2010-06-23 10:11
    - Update Helmut 2011-02-05 18:48
      - Q&A published 14 March 2011 Helmut 2011-03-16 13:44
        
        Q&A published 14 March 2011 ElMaestro 2011-03-16 14:20
        Phoenix/WinNonlin 6.1.0.173 Helmut 2011-03-17 04:23
        ANOVA party prevails d_labes 2011-03-17 11:00
        
        THX! Helmut 2011-03-19 02:59
        
        Outlier d_labes 2011-03-24 11:55
        
        Outliers - yes, but how? Helmut 2011-03-24 15:09
        
        Questions and Ambiguities d_labes 2011-03-28 14:16
        Residuals and Outliers in Replicate Design Crossover Studies d_labes 2011-04-04 08:53
        
        Info requested ElMag 2011-03-24 12:45
        
        Confused as well... Helmut 2011-03-24 16:50
        
        Q&A published 14 March 2011 Priyanka_S 2011-03-21 14:28
        
        SAS code: Warning d_labes 2011-03-21 16:08
        
        Copy & paste Helmut 2011-03-21 22:38
        
        Subtleties, flaws, questions d_labes 2011-03-22 09:24
        
        Subtleties, flaws, questions Helmut 2011-03-27 20:35
        
        Not estimable in the model The user 2017-03-14 10:16
        
        Not estimable in the model ElMaestro 2017-03-14 11:02
        
        Not estimable in the model The user 2017-03-14 12:13
        
        Not estimable in the model ElMaestro 2017-03-14 12:41
        
        Not estimable in the model Helmut 2017-03-18 21:59
        
        Food not the same between groups Beholder 2021-11-10 14:35
        
        Food not the same between groups ElMaestro 2021-11-17 09:50