Bioequivalence and Bioavailability Forum • FDA Mixed up

FDA Mixed up [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2012-10-23 18:23 (4630 d 19:47 ago) – Posting: # 9450
Views: 8,951

Dear Helmut!

❝ FDA wants to see SAS Proc GLM for the partial replicate (scaled) and SAS Proc Mixed for the full replicate and both designs in (unscaled) ABE.

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.
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. At least as long as no special structure of the variance-covariance matrix of the error term is specified.

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.

—
Regards,

Detlew

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 upd_labes 2012-10-23 16:23
    - FDA Mixed up Helmut 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