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RegisterBioequivalence concluded only in AUC [Regulatives / Guidelines]
Dear All,
I have one product (NDA approved) and now I want to develop a new pharmaceutical form of the same, as a extension line. But the new pharmaceutical form is expected to have a higher bioavailability, so a strength reduction will be proposed in order to find the dose which match with the previous formulation in terms of exposure.
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.
Has anyone had experience with a similar case?
What do you think?
Thank you so much
Best regards,
I have one product (NDA approved) and now I want to develop a new pharmaceutical form of the same, as a extension line. But the new pharmaceutical form is expected to have a higher bioavailability, so a strength reduction will be proposed in order to find the dose which match with the previous formulation in terms of exposure.
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.
Has anyone had experience with a similar case?
What do you think?
Thank you so much
Best regards,
Complete thread:
- Bioequivalence concluded only in AUCBrus 2026-02-25 13:39 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence concluded only in AUC dshah 2026-02-26 08:44
Ing. Helmut Schütz