Abiraterone acetate product-specific bioequivalence guidance
Human
Scientific guidelines
This document provides product-specific guidance on the demonstration of the bioequivalence of abiraterone acetate.
Keywords: Bioequivalence, generics, abiraterone acetate
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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
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