MIXED up and lost in design [General Sta­tis­tics]

posted by d_labes  – Berlin, Germany, 2009-10-07 18:48 (6085 d 21:57 ago) – Posting: # 4318
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Dear KVitamin,

❝ I apply the SAS proc mixed because this procedure is assessed in FDA's guidance and I want to learn how works it (it is not simple).


The Proc MIXED named in the FDA guidance "Statistical approaches ..." is recommended for replicate cross-over studies.
Here we are talking about the classical 2x2 cross-over.
Traditionally this is evaluated with Proc GLM if you use SAS for evaluation.

❝ If I have a study data set as Helmuts data with 52 subjects and I calculate intra-CV and inter-CV based on your help, I will get results for all the subjects not for subjects in group T or subjects in group R, separately.


There are no such subjects in group T or group R! In a cross-over study each subject gets both treatments.

I strongly suggest that you study some textbooks about design and evaluation of bioequivalence studies before fiddling with a complex piece of software such as Proc MIXED.
A good starting point are Helmut's lectures. For a collection of books see here.

Regards,

Detlew

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