Bioequivalence and Bioavailability Forum • scale average bioequivalence for parallel design

scale average bioequivalence for parallel design [RSABE / ABEL]

posted by Mahmoud – Jordan, 2022-06-15 14:33 (1038 d 10:40 ago) – Posting: # 23059
Views: 3,230

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]

Complete thread:

scale average bioequivalence for parallel designMahmoud 2022-06-15 12:33 [RSABE / ABEL]
- Parallel design: Maybe (‼) in exceptional cases Helmut 2022-06-15 14:08
  - Parallel design: Maybe (‼) in exceptional cases Mahmoud 2022-06-15 23:26