Octreotide acetate product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg or 30 mg.

Keywords: Bioequivalence, generics, octreotide

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