This document provides product-specific guidance on the demonstration of the bioequivalence of exenatide.
Keywords: Bioequivalence, generics, exenatide
Abbreviations:
BCS Classification: Biopharmaceutics Classification System
AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
Cmax: 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
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 closedConsultation dates:
to Reference Number: EMA/CHMP/474782/2016Summary:
This document provides product-specific guidance on the demonstration of the bioequivalence of exenatide.