Bioequivalence and Bioavailability Forum • Bear vs. Phoenix & SAS

Bear vs. Phoenix & SAS [🇷 for BE/BA]

posted by Helmut – Vienna, Austria, 2015-04-20 19:34 (3291 d 22:40 ago) – Posting: # 14718
Views: 25,266

Dear all,

I closed this thread. Let’s continue over here. I would say that nowadays few people perform a replicated study without having reference-scaling in mind. What would we need in bear?

A basic model which we use if the conditions for scaling are not fulfilled.
For the FDA that would be a mixed-effects model as given in the 2001 guidance and the progesterone guidance.
For the EMA we would need an “all effects fixed” model (Method A of the Q&A).
FDA – RSABE: The progesterone guidance, again.
EMA – ABEL: The Q&A, Methods A & B. Crippled model to get CV_wR.

We have shown in the past that we get the same results for EMA’s data sets I & II (also when we make #II unbalanced) in PHX and SAS (THX to Shuanghe and Jean-Michel!). I would say, that’s the target.

PS: @ElMaestro. Remember that one of the referees of our reference dataset-MS wanted to discuss the statistical model and we refused? Until somebody shows that what regulators want right now is crap (which will happen – at least partly) we should get the same results independent from the software used. I would be happy if a noncommercial one is amongst them.

—
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Helmut Schütz

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Complete thread:

Bear vs. Phoenix & SASHelmut 2015-04-20 17:34
- R vs. Phoenix & SAS? yjlee168 2015-04-20 19:36
  - R vs. Phoenix & SAS? Helmut 2015-04-21 01:02
    - lme() does not work with all fixed effects yjlee168 2015-04-21 23:41
      - lme() does not work with all fixed effects Astea 2016-11-04 00:13
        
        lmer: Method B (PE catched for imbalanced dataset!!!) and Method C mittyri 2016-11-05 17:38
        
        lmer: Method B (PE catched for imbalanced dataset!!!) and Method C Astea 2016-11-05 19:27
        
        lmer: Method B is ready for scaling mittyri 2016-11-05 20:01
        
        lmer: Method B is ready for scaling Astea 2016-11-06 11:50
        
        lmer: Method B is ready for scaling mittyri 2016-11-07 06:07
- info for lsmeans yjlee168 2015-04-20 21:34
  - info for lsmeans Helmut 2015-04-21 01:15
    - once more about R and replicate designes Astea 2016-11-02 23:43
      - once more about R and replicate designes VStus 2016-11-06 11:34
        
        Getting variance components from the lmer output StatR 2017-02-03 13:53
        
        Getting variance components from the lmer output VStus 2017-02-03 15:47
        
        Getting variance components from the lmer output StatR 2017-02-03 17:12
        
        Getting variance components d_labes 2017-02-07 11:16
        
        Getting variance components StatR 2017-02-07 11:36
        Getting variance components StatR 2017-02-08 08:41
        
        Getting variance components d_labes 2017-02-08 10:13
        
        Getting variance components StatR 2017-02-08 10:19
        
        Data structure Helmut 2017-02-08 10:33
        
        Data structure StatR 2017-02-08 10:49