Abiraterone product-specific bioequivalence guidance
This revision concerns the availability of a higher (500 mg) strength.
Draft abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance (PDF/165.92 KB)Draft: consultation open
First published: 15/06/2020
Consultation dates: 15/06/2020 to 30/09/2020
EMA/CHMP/474712/2016 Rev. 1
Abiraterone tablets 250 mg product-specific bioequivalence guidance (PDF/134.89 KB)Adopted
First published: 03/03/2017
Last updated: 03/03/2017
Legal effective date: 01/09/2017
Description: This document provides product-specific guidance on the demonstration of the bioequivalence of abiraterone.
Keywords: Bioequivalence, generics, abiraterone
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
- Cmax: maximum plasma concentration