Log in
RegisterEzetimibe: Parent vs Metabolite data [Regulatives / Guidelines]
Dear Siri
As long as the parent drug is quantifiable and the complete pharmacokinetics of the unchanged drug can be established you have to demonstrate bioequivalence based on the parent drug according to CPMP/EWP/QWP/1401/98 Rev. 1. The active metabolite does not need to be measured. If you want to measure the active metabolite (for what reasons ever) then I suggest to present the data only as supportive evidence of comparable therapeutic outcome and not as primary objective of the study.
I hope this helps.
Kind regards
Dan
As long as the parent drug is quantifiable and the complete pharmacokinetics of the unchanged drug can be established you have to demonstrate bioequivalence based on the parent drug according to CPMP/EWP/QWP/1401/98 Rev. 1. The active metabolite does not need to be measured. If you want to measure the active metabolite (for what reasons ever) then I suggest to present the data only as supportive evidence of comparable therapeutic outcome and not as primary objective of the study.
I hope this helps.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Ezetimibe: Parent vs Metabolite data Srinetram 2013-09-03 09:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ezetimibe: Parent vs Metabolite dataDr_Dan 2013-09-03 10:44
Ing. Helmut Schütz