FDA: PROC MIXED (‼) for ABE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-09-17 17:11 (39 d 13:06 ago) – Posting: # 22584
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Dear Mahmoud!

» Dear Dr Helmut

Not a doctor. No intentions to become one. Told you that numerous times before.

» If SAS® is used for statistical analysis
» PROC MIXED should be used for fully replicated (4-way) BE studies
» PROC GLM should be used for partially replicated (3-way) BE studies

Since you didn’t bother to read the entire thread as suggested – and not even the subject line of my post – would you mind to digest this one?

Your quote refers to Reference-scaled Average Bioequivalence (\(\small{s_\textrm{wR}\geq 0.294}\)).
However, for (conventional, unscaled) Average Bioequivalence (\(\small{s_\textrm{wR}<0.294}\)) PROC MIXED should be used regardless the design.

Dif-tor heh smusma 🖖
Helmut Schütz
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