Deferasirox product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of deferasirox.
Keywords: Bioequivalence, generics, deferasirox
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Deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg), and granules (90 mg, 180 mg and 360 mg) product-specific bioequivalence guidance (PDF/160.95 KB)
Adopted
First published: 14/06/2021
Legal effective date: 01/01/2022
EMA/CHMP/472383/2020 -
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Overview of comments received on 'Deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg), and granules (90 mg, 180 mg and 360 mg) product-specific bioequivalence guidance' (EMA/CHMP/472383/2020) (PDF/177 KB)
First published: 14/06/2021
EMA/CHMP/209314/2021
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