scale average bioequivalence for parallel design [RSABE / ABEL]

posted by Mahmoud  – Jordan, 2022-06-15 14:33 (707 d 06:05 ago) – Posting: # 23059
Views: 1,980

Dear All
In the following paper

Statistical methodology for highly variable compounds: A novel design approach for the Ofatumumab Phase 2 bioequivalence study

Used scale average bioequivalence for parallel design

Is this method accepted by FDA and EMA

M.Youseef


Edit: Category changed; see also this post #1[Helmut]

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