Bioequivalence and Bioavailability Forum • Switchability = IBE

Switchability = IBE [Design Issues]

posted by Achievwin – US, 2022-05-20 16:19 (705 d 23:37 ago) – Posting: # 23007
Views: 1,951

❝ 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).

Thanks for the clarification

I vaguely recall when you don't have subject by formulation interaction in a replicate study design (4-period full replicate design???) you can request switchability (Metadate ANDA I guess)

My question is can we assess this subject by formulation interaction in a 3-period partial replicate design?) what additional statistical test one needs for documenting this?

Complete thread:

Switchability with replicate design studies Achievwin 2022-05-20 04:44 [Design Issues]
- Switchability = IBE Helmut 2022-05-20 09:17
  - Switchability = IBEAchievwin 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