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

posted by Mahmoud  – Jordan, 2021-09-17 15:24 (81 d 21:05 ago) – Posting: # 22582
Views: 758

» Please read the entire thread again. The FDA does recommend PROC MIXED for ABE in all guidances.
» That’s the problem.

Dear Dr Helmut

Draft Guidance on Progesterone

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

or other software accomplishes same objectives


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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