Bioequivalence and Bioavailability Forum • Switchability = IBE

Switchability = IBE [Design Issues]

posted by Helmut – Vienna, Austria, 2022-05-20 11:17 (1148 d 15:59 ago) – Posting: # 23006
Views: 3,983

Hi Achievwin,

population BE (prescribability) and individual BE (switchability) are of historic interest only. Both are not assessed in any of the currently recommended approaches (average BE, reference-scaled BE, average BE with expanding limits).

❝ If we want to introduce assessment or claim using BE study which design is more appropriate?

Define ‘appropriate’. An appetizer.

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Complete thread:

Switchability with replicate design studies Achievwin 2022-05-20 04:44 [Design Issues]
- Switchability = IBEHelmut 2022-05-20 09:17
  - Switchability = IBE Achievwin 2022-05-20 14:19
    - S × F interaction Helmut 2022-05-20 15:33
      - S × F interaction Achievwin 2022-05-20 23:32
      - S × F interaction Brus 2023-06-06 11:02
        
        S × F interaction Helmut 2023-06-07 10:34
        
        S × F interaction Achievwin 2023-06-08 10:21