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