Abiraterone acetate product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of abiraterone acetate.
Keywords: Bioequivalence, generics, abiraterone acetate
Revision 1 - This revision concerns the availability of a higher (500 mg) strength.
-
List item
Abiraterone acetate tablets 250 mg and 500 mg product-specific bioequivalence guidance - Revision 1 (PDF/349.61 KB)
Adopted
First published: 23/11/2020
EMA/CHMP/474712/2016 Rev. 1 Corr 1 -
List item
Overview of comments received on 'Abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance' - Revision 1 (PDF/193.88 KB)
Adopted
First published: 23/11/2020
EMA/CHMP/567816/2020 -
List item
Draft abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance - Revision 1 (PDF/165.92 KB)
Draft: consultation closed
First published: 15/06/2020
Consultation dates: 15/06/2020 to 30/09/2020
EMA/CHMP/474712/2016 Rev. 1
First version
-
List item
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
EMA/CHMP/474712/2016 -
List item
Draft abiraterone tablets 250 mg product-specific bioequivalence guidance (PDF/78.32 KB)
Draft: consultation closed
First published: 01/08/2016
Last updated: 01/08/2016
Consultation dates: 01/08/2016 to 31/10/2016
EMA/CHMP/474712/2016
Abbreviations:
- 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