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

Current version

Octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg and 30 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/291571/2018

Document history

Overview of comments received on 'Octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg and 30 mg product-specific bioequivalence guidance' (EMA/CHMP/291571/2018)

Reference Number: EMA/CHMP/682121/2018

Draft octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg or 30 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 27/06/2018 to 30/09/2018 Reference Number: EMA/CHMP/291571/2018