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

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

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

First version

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