Do regulatory agencies accept steady-state equivalence studies? [Design Issues]

posted by libaiyi – China, 2024-12-04 09:34 (64 d 05:07 ago) – Posting: # 24307
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Dear friend,

I am currently conducting a single-dose bioequivalence study, but it is difficult to achieve equivalence due to high variability. I am wondering if it is possible to design a steady-state bioequivalence study, but I don't know if regulatory agencies accept steady-state BE studies like this, if there have been successful precedents for such a design, and what the conditions for its application are. Many thanks.


Libaiyi

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