Capecitabine product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, capecitabine

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

Capecitabine film-coated tablets 150, 500 mg product-specific bioequivalence guidance - adopted

AdoptedReference Number: EMA/CHMP/315237/2014Legal effective date: 01/12/2015Summary:

This document provides product-specific guidance on demonstration of bioequivalence of capecitabine

Document history - First version (current)

Capecitabine film-coated tablets 150, 500 mg product-specific bioequivalence guidance - adopted

AdoptedReference Number: EMA/CHMP/315237/2014Legal effective date: 01/12/2015Summary:

This document provides product-specific guidance on demonstration of bioequivalence of capecitabine

Draft capecitabine product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 15/11/2013 to 15/02/2014Reference Number: CHMP/PKWP/EMA/423732/2013Summary:

Capecitabine product-specific bioequivalence guidance

Overview of comments received on 'draft capecitabine product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/116324/2014