Cabozantinib product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of cabozantinib tablet 20 mg, 40 mg and 60 mg.

Keywords: Bioequivalence, generics, cabozantinib

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

Cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 mg and 80 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/790333/2018 Legal effective date: 01/04/2020

Document history

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 21/12/2018 to 30/06/2019 Reference Number: EMA/CHMP/790333/2018