Asenapine product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, asenapine

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

Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/158542/2016Legal effective date: 01/11/2016Summary:

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

Document history

Overview of comments on 'Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/162825/2016Summary:

Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance

Draft asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 15/07/2015 to 01/11/2015Reference Number: EMA/CHMP/PKWP/269533/2015Summary:

The European Medicines Agency has decided to routinely publish product-specific bioequivalence guidance for a more consistent approach to the assessment of marketing authorisation applications for generic medicines across all authorisation routes available in the European Union. This guidance document describes the specific requirements for the demonstration of bioequivalence for asenapine sublingual.