Enzalutamide product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of enzalutamide.
Keywords: Bioequivalence, generics, enzalutamide
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Enzalutamide soft capsule 40 mg and film-coated tablet 40 mg & 80 mg product-specific bioequivalence guidance (PDF/155.3 KB)
Adopted
First published: 27/06/2022
Legal effective date: 01/01/2023
EMA/CHMP/371467/2021 -
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Draft enzalutamide soft capsule 40 mg and film-coated tablet 40 mg & 80 mg product-specific bioequivalence guidance (PDF/156.94 KB)
Draft: consultation closed
First published: 15/12/2021
Consultation dates: 15/12/2021 to 31/03/2022
EMA/CHMP/371467/2021
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