Bioequivalence and Bioavailability Forum • RSAB model overspecified

RSAB model overspecified [RSABE / ABEL]

posted by Wolfgang – Switzerland, 2013-08-05 16:37 (4698 d 23:52 ago) – Posting: # 11202
Views: 14,025

Hi everyone,

For highly variable drugs, the reference-scaled average bioequivalence method is suggested by FDA.
They request that a "conventional approach" analysis be done with some specific code, containing a random statement for SAS Proc Mixed,
random tmt / sub=subject type=FA0(2);
But, in the case of a partially replicated design (RRT/RTR/TRR), this model is overspecified, which can lead to various error messages from SAS, to non-convergence, and to unstable results.
Has anyone thought about using type=FA0(1) instead? Which in this case amounts to the same model but correctly specified.
What would FDA's attitude be towards this?

Complete thread:

RSAB model overspecifiedWolfgang 2013-08-05 14:37 [RSABE / ABEL]
- RSAB model overspecified jag009 2013-08-05 15:35
- Proc Mixed FA0(1) for partial replicate d_labes 2013-08-05 15:59
  - Proc Mixed FA0(1) for partial replicate Wolfgang 2013-08-05 16:24
    - Proc Mixed FA0(1) for partial replicate ElMaestro 2013-08-05 17:19
      - Proc Mixed FA0(1) for partial replicate Wolfgang 2013-08-06 08:35
        
        Proc Mixed FA0(1) for partial replicate ElMaestro 2013-08-06 10:34
    - Proc Mixed FA0(1) for partial replicate d_labes 2013-08-06 10:30
      - FA0(1) for partial replicate in Phoenix Helmut 2013-08-07 15:13
        
        FA0(1) for partial replicate in SAS d_labes 2013-08-08 09:42
        FA0(1) for partial replicate in Phoenix lhughes 2013-08-30 15:17
        
        FA0(1) in PHX: works (& more questions) Helmut 2013-08-30 17:07