Dimethyl fumarate product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of dimethyl fumarate.

Keywords: Bioequivalence, generics, dimethyl fumarate

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 - enters into effect from 1/12/2018

Dimethyl fumarate gastro-resistant capsule 120 mg and 240 mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/421315/2017Legal effective date: 01/12/2018

Document history

Dimethyl fumarate gastro-resistant capsule 120 mg and 240 mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/421315/2017Legal effective date: 01/12/2018

Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/730229/2017

Draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 03/08/2017 to 31/10/2017Reference Number: EMA/CHMP/421315/2017Summary:

This document provides product-specific guidance on the demonstration of the bioequivalence of dimethyl fumarate