Lapatinib product-specific bioequivalence guidance

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
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current effective version

Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version

Adopted Reference Number: EMA/CHMP/257298/2018 Corr. Legal effective date: 01/04/2022

Document history

Overview of comments received on 'Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (1st / 2nd draft)

Reference Number: EMA/CHMP/89249/2021

Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (2nd draft)

Draft: consultation closed Consultation dates: 06/07/2020 to 31/01/2021 Reference Number: EMA/CHMP/257298/2018 Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of lapatinib film-coated tablet 250 mg. This is the second public consultation after significant revision of the first draft requirements in response to the comments from the first public consultation.

Overview of comments received on 'Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (1st draft)

Adopted Reference Number: EMA/CHMP/567884/2020

Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (1st draft)

Draft: consultation closed Consultation dates: 27/06/2018 to 30/09/2018 Reference Number: EMA/CHMP/257298/2018