Lapatinib product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of lapatinib film-coated tablet 250 mg.
Keywords: Bioequivalence, generics, lapatinib
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 'Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (1st / 2nd draft) (PDF/282.96 KB)
First published: 13/09/2021
EMA/CHMP/89249/2021 -
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Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (2nd draft) (PDF/149.33 KB)
Draft: consultation closed
First published: 03/07/2020
Last updated: 17/11/2020
Consultation dates: 06/07/2020 to 31/01/2021
EMA/CHMP/257298/2018 -
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Overview of comments received on 'Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (1st draft) (PDF/191.26 KB)
Adopted
First published: 23/11/2020
EMA/CHMP/567884/2020 -
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Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (1st draft) (PDF/78.07 KB)
Draft: consultation closed
First published: 27/06/2018
Last updated: 27/06/2018
Consultation dates: 27/06/2018 to 30/09/2018
EMA/CHMP/257298/2018