Log in
RegisterBioequivalence concluded only in AUC [Regulatives / Guidelines]
Hi Brus!
This is an interesting one. As a NDA holder, if you have already proved PK-PD relationship using AUC, then it could be advantageous.
Generally this approach is considered safe for regulatory application and lot of cases can be found in history for this. Even IR vs MR also mainly focuses on AUC and not Cmax.
Hope this helps.
Divyen
❝ But since the exposure change between formulation is not proportional (i.e. 25% change in Cmax and 90% in AUC), and dose adjustement to achieve at the same time both parameters near to T/R ratio of 100% is not possible. So, a way proposed is to select the dose to obtain the AUC T/R ratio of 100% and to justify the no relevance of Cmax for efficacy and the high relevance of AUC.
This is an interesting one. As a NDA holder, if you have already proved PK-PD relationship using AUC, then it could be advantageous.
Generally this approach is considered safe for regulatory application and lot of cases can be found in history for this. Even IR vs MR also mainly focuses on AUC and not Cmax.
Hope this helps.
Divyen
Complete thread:
- Bioequivalence concluded only in AUC Brus 2026-02-25 13:39 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence concluded only in AUCdshah 2026-02-26 08:44
Ing. Helmut Schütz