Bosutinib product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of Bosutinib.

Keywords: Bioequivalence, generics, bosutinib

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 version - effective from 01/06/2024

Bosutinib film-coated tablets 100, 400 and 500 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/590937/2022 Legal effective date: 01/06/2024

English (EN) (138.11 KB - PDF)

First published: 28/11/2023

Bosutinib film-coated tablets 100, 400 and 500 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 22/06/2023 to 30/09/2023 Reference Number: EMA/CHMP/590937/2022

English (EN) (138.56 KB - PDF)

First published: 22/06/2023