Bioequivalence and Bioavailability Forum • FDA Mixed up

FDA Mixed up [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2012-10-23 18:34 (4986 d 07:10 ago) – Posting: # 9451
Views: 10,804

Dear Detlew!

❝ I must confess that I never understood why the FDA statisticians (they are, really :cool: ) recommend the use of SAS Proc GLM or MIXED within their analysis of intra-subject contrasts for the two different designs within the scABE framework.

Agree. Not the slightest (!) idea. :confused:

❝ Since the contrasts (T-R or R1-R2) are analyzed via an model with sequence group as the solely effect (fixed) both SAS procedures will give exactly the same results AFAIK.

Yes.

❝ On the other hand the Proc Mixed code for unscaled ABE in case of the partial replicate crossover doesn't work in all cases as we had discussed here often.

Oh dear.

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

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Complete thread:

Replicate Design: Scaling FDA Ben 2012-10-23 11:32 [RSABE / ABEL]
- Maybe – but why? Helmut 2012-10-23 15:35
  - Maybe – but why? Ben 2012-10-23 16:03
    - Got it. Helmut 2012-10-23 16:23
  - FDA Mixed up d_labes 2012-10-23 16:23
    - FDA Mixed upHelmut 2012-10-23 16:34
  - Maybe – but why? Ben 2012-10-27 17:04
    - Maybe – but why? Helmut 2012-10-27 17:57
      - Maybe – but why? Ben 2012-10-28 13:57
        
        Potvin (and beyond?) Helmut 2012-10-28 15:59
        
        Potvin (and beyond?) Ben 2012-11-01 10:17