Bioequivalence and Bioavailability Forum • Subject accountability, Proc MIXED or equivalent

Subject accountability, Proc MIXED or equivalent [Regulatives / Guidelines]

posted by d_labes – Berlin, Germany, 2008-09-02 13:13 (6076 d 20:25 ago) – Posting: # 2301
Views: 23,896

Dear all,

Subject accountability, page 14 (lines 574-576)
'All treated subjects should be included in the statistical analysis, with the exception of subjects in a crossover trial who do not complete at least one period receiving each of the test and reference products (or who fail to complete the single period in a parallel group trial)'.

This calls ultimately for evaluation with SAS Proc MIXED or equivalent software because the usually employed GLM-ANOVA exclude subjects "listwise" (at least in SAS), i.e. subjects with missing data at any period will be excluded.

As is known in the standard 2x2 cross-over subjects with missing data do not contribute to the ratio or difference of Test versus Reference. Only the variability is affected, usually to a minor extent.

Thus it is not clear why GLM-ANOVA should be abandoned, especially in light of lines 500 ff, which request ANOVA.

—
Regards,

Detlew

Complete thread:

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