Vandetanib product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, vandetanib

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

Vandetanib film-coated tablets 100 mg and 300 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/474883/2016 Legal effective date: 01/09/2017

Document history

Draft vandetanib film-coated tablets 100 and 300 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 01/08/2016 to 31/10/2016 Reference Number: EMA/CHMP/474883/2016 Summary:

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