Prasugrel product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, prasugrel

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

Prasugrel film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance - Revision 2

Adopted Reference Number: EMA/151699/2025 Rev. 2 Legal effective date: 01/12/2025

Document history - Revision 1

Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/158772/2016/Rev.1 Legal effective date: 01/12/2018

Overview of comments received on 'Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/644911/2017

Draft prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance - Revision 1

Draft: consultation closed Consultation dates: 03/08/2017 to 31/10/2017 Reference Number: EMA/CHMP/158772/2016/Rev. 1 Summary:

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

Document history - First version

Prasugrel film-coated tablets 5 and 10 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/158772/2016 Legal effective date: 01/11/2016 Summary:

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

Overview of comments received on 'Prasugrel film-coated tablets 5 and 10 mg product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/162888/2016 Summary:

Overview of comments received on 'Prasugrel film-coated tablets 5 and 10 mg product-specific bioequivalence guidance' (EMA/CHMP/PKWP/36761/2015)

Draft prasugrel film-coated tablets 5 and 10 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/07/2015 to 01/11/2015 Reference Number: EMA/CHMP/PKWP/36761/2015 Summary:

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 prasugrel.