Octreotide acetate product-specific bioequivalence guidance
Table of contents
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
- 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
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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) (PDF/255.04 KB)
First published: 08/02/2019
EMA/CHMP/682121/2018 -
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Draft octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg or 30 mg product-specific bioequivalence guidance (PDF/82.42 KB)
Draft: consultation closed
First published: 27/06/2018
Last updated: 27/06/2018
Consultation dates: 27/06/2018 to 30/09/2018
EMA/CHMP/291571/2018