Abiraterone acetate product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of abiraterone acetate.

Keywords: Bioequivalence, generics, abiraterone acetate

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current effective version

Revision 2 - This revision concerns the recommendation to conduct the study in male subjects only.

Document history

Revision 1 - This revision concerns the availability of a higher (500 mg) strength.

Abiraterone acetate tablets 250 mg and 500 mg product-specific bioequivalence guidance - Revision 1

AdoptedReference Number: EMA/CHMP/474712/2016 Rev. 1 Corr 1Summary:

Abiraterone acetate tablets 250 mg and 500 mg product-specific bioequivalence guidance

Overview of comments received on 'Abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance' - Revision 1

AdoptedReference Number: EMA/CHMP/567816/2020Summary:

Overview of comments received on 'Abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance' - Revision 1

Draft abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance - Revision 1

Consultation dates: 15/06/2020 to 30/09/2020Draft: consultation closedReference Number: EMA/CHMP/474712/2016 Rev. 1

First version

Abiraterone tablets 250 mg product-specific bioequivalence guidance

AdoptedLegal effective date: 01/09/2017Reference Number: EMA/CHMP/474712/2016

Draft abiraterone tablets 250 mg product-specific bioequivalence guidance

Consultation dates: 01/08/2016 to 31/10/2016Draft: consultation closedReference Number: EMA/CHMP/474712/2016Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of abiraterone.

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