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RegisterDo regulatory agencies accept steady-state equivalence studies? [Design Issues]
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
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
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- HVD(P)s: steady state = history libaiyi 2024-12-04 09:52
- 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
- steady-state in patients Helmut 2024-12-17 09:45
- HVD(P)s: steady state = history Helmut 2024-12-04 09:37
Ing. Helmut Schütz