Exenatide product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, exenatide

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

Exenatide powder and solvent for prolonged-release suspension for injection, 2 mg, and powder and solvent for prolonged-release suspension for injection in pre-filled pen, 2 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/474782/2016 Legal effective date: 01/09/2017

Document history

Draft exenatide powder and solvent for prolonged-release suspension for injection, 2 mg, and powder and solvent for prolonged-release suspension for injection in pre-filled pen, 2 mg product-specific bioequivalence guida...

Draft: consultation closed Consultation dates: 01/08/2016 to 31/10/2016 Reference Number: EMA/CHMP/474782/2016 Summary:

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