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

    Document history

    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

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