Lenalidomide product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of lenalidomide.
Keywords: Bioequivalence, generics, lenalidomide
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
-
List item
Overview of comments on 'lenalidomide hard gelatine capsules 2.5, 5, 7.5, 10, 15 and 25mg product-specific bioequivalence guidance’ (PDF/78.11 KB)
First published: 07/04/2016
Last updated: 07/04/2016
EMA/CHMP/206166/2016 -
List item
Draft lenalidomide hard gelatine capsules 2.5, 5, 7.5, 10, 15 and 25mg product-specific bioequivalence guidance (PDF/72.14 KB)
Draft: consultation closed
First published: 06/10/2015
Last updated: 06/10/2015
Consultation dates: 01/10/2015 to 01/01/2016
EMA/CHMP/PKWP/152216/2015