Miglustat product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of miglustat. Please note that no comments have been received for this guideline during the public consultation period.

Keywords: Bioequivalence, generics, miglustat

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

Miglustat hard capsules 100 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/675841/2014 Legal effective date: 01/06/2015 Summary:

This document provides product-specific guidance on demonstration of bioequivalence of miglustat

Document history

Miglustat hard capsules 100 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/675841/2014 Legal effective date: 01/06/2015 Summary:

This document provides product-specific guidance on demonstration of bioequivalence of miglustat

Draft miglustat product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/11/2013 to 15/02/2014 Reference Number: CHMP/PKWP/EMA/422796/2013 Summary:

Miglustat product-specific bioequivalence guidance