Everolimus product-specific bioequivalence guidance
This document provides product-specific guidance on the demonstration of the bioequivalence of everolimus.
Keywords: Bioequivalence, generics, everolimus
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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Overview of comments received on ‘Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and 5 mg product-specific bioequivalence guidance’ (PDF/115.26 KB)
First published: 03/01/2017
Last updated: 03/01/2017
EMA/CHMP/620299/2016 -
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Draft Everolimus tablets 0.25, 0.5, 0.75 and 1mg; 2.5, 5 and 10mg, dispersible tablets 0.1 and 0.25mg; 2, 3 and 5mg product-specific bioequivalence guidance (PDF/94.28 KB)
Draft: consultation closed
First published: 02/05/2016
Last updated: 02/05/2016
Consultation dates: 02/05/2016 to 31/07/2016
EMA/CHMP/154772/2016