Switchability = IBE [Design Issues]

posted by Achievwin – US, 2022-05-20 16:19 (785 d 10:28 ago) – Posting: # 23007
Views: 2,288

❝ 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?

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