Bioequivalence and Bioavailability Forum • Q&A published 14 March 2011

Q&A published 14 March 2011 [BE/BA News]

posted by ElMaestro – Denmark, 2011-03-16 15:20 (4955 d 15:33 ago) – Posting: # 6763
Views: 36,057

Hehe,

A simple linear mixed model, which assumes identical within-subject variability (Method B), may be acceptable as long as results obtained with the two methods do not lead to different regulatory decisions. However, in borderline cases and when there are many included subjects who only provide data for a subset of the treatment periods, additional analysis using method A might be required.
At the time of protocol writing you do not know if there will be data gaps. Therefore, you cannot write which evaluation method you will ultimately be using. This means (??) that one has to apply both methods, check if the BE conclusions are the same and then, in case there are differences, discard a method which gives unbiased variance estimates.

An advantage of Method C is that it directly calculates s²_wr However, sometimes the algorithm fails to converge.
No, the Al Gore Rhythm will converge if the guy doing the statistics knows what he is doing in terms of controlling the ini-values and other optimizer settings (flat multidimensional likelihood surfaces are hypothetical).

Complete thread:

EMA BE-GL: Clarifications / Corrections? Helmut 2010-06-22 18:53
- 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 2011ElMaestro 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