Pazopanib product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, pazopanib

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

Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/154805/2016 Legal effective date: 01/07/2017

Document history - First version (current)

Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/154805/2016 Legal effective date: 01/07/2017

Overview of comments received on Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance

Reference Number: EMA/CHMP/693923/2016

Draft Pazopanib film-coated tablet 200mg and 400mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 02/05/2016 to 31/07/2016 Reference Number: EMA/CHMP/154805/2016