RSAB model overspecified [RSABE / ABEL]

posted by Wolfgang – Switzerland, 2013-08-05 16:37 (3887 d 23:52 ago) – Posting: # 11202
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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?

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