Ibuprofen product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, ibuprofen

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

Revision 2

Ibuprofen oral use immediate release formulations 200 - 800 mg product-specific bioequivalence guidance - Revision 2

Adopted Reference Number: EMA/122751/2025 Rev.2 Legal effective date: 01/11/2025

Current version - Revision 1

Ibuprofen oral use immediate release formulations 200 - 800 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/CHMP/356876/2017 Rev.1 Legal effective date: 01/01/2024

Overview of comments received on 'Ibuprofen oral use immediate release formulations 200–800 mg productspecific bioequivalence guidance' (EMA/CHMP/356876/2017 Rev.1)

Reference Number: EMA/CHMP/735541/2022

Document history

Draft ibuprofen oral use immediate release formulations 200 – 800 mg product-specific bioequivalence guidance - Revision 1

Draft: consultation closed Consultation dates: 04/04/2022 to 31/07/2022 Reference Number: EMA/CHMP/356876/2017 Rev.1

Ibuprofen oral use immediate release formulations 200 - 800 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/356876/2017 Legal effective date: 01/12/2018

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Reference Number: EMA/CHMP/730723/2017

Draft ibuprofen 200 - 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 03/08/2017 to 31/10/2017 Reference Number: EMA/CHMP/356876/2017 Summary:

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