Bioequivalence and Bioavailability Forum • Do regulatory agencies accept steady-state equivalence studies?

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

posted by libaiyi – China, 2024-12-04 09:34 (212 d 07:00 ago) – Posting: # 24307
Views: 5,557

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

Complete thread:

Do regulatory agencies accept steady-state equivalence studies?libaiyi 2024-12-04 08:34 [Design Issues]
- HVD(P)s: steady state = history Helmut 2024-12-04 09:37
  - HVD(P)s: steady state = history libaiyi 2024-12-04 09:52
    - HVD(P)s: steady state = history dshah 2024-12-05 07:22
- Do regulatory agencies accept steady-state equivalence studies? xtianbadillo 2024-12-16 20:59
  - steady-state in patients Helmut 2024-12-17 09:45
    - steady-state in patients qualityassurance 2025-01-09 10:59