Ibuprofen product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of ibuprofen.
Keywords: Bioequivalence, generics, ibuprofen
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
- Cmax: maximum plasma concentration
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Ibuprofen oral use immediate release formulations 200 - 800 mg product-specific bioequivalence guidance - Revision 1 (PDF/151.76 KB)
Adopted
First published: 22/06/2023
Legal effective date: 01/01/2024
EMA/CHMP/356876/2017 Rev.1 -
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Overview of comments received on 'Ibuprofen oral use immediate release formulations 200–800 mg productspecific bioequivalence guidance' (EMA/CHMP/356876/2017 Rev.1) (PDF/1.91 MB)
First published: 22/06/2023
EMA/CHMP/735541/2022
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Draft ibuprofen oral use immediate release formulations 200 – 800 mg product-specific bioequivalence guidance - Revision 1 (PDF/176.46 KB)
Draft: consultation closed
First published: 04/04/2022
Consultation dates: 04/04/2022 to 31/07/2022
EMA/CHMP/356876/2017 Rev.1 -
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Ibuprofen oral use immediate release formulations 200 - 800 mg product-specific bioequivalence guidance (PDF/78.48 KB)
Adopted
First published: 26/06/2018
Last updated: 26/06/2018
Legal effective date: 01/12/2018
EMA/CHMP/356876/2017 -
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Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance (PDF/117.76 KB)
First published: 04/12/2018
EMA/CHMP/730723/2017 -
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Draft ibuprofen 200 - 800 mg oral use, immediate release formulations product-specific bioequivalence guidance (PDF/77.21 KB)
Draft: consultation closed
First published: 03/08/2017
Last updated: 03/08/2017
Consultation dates: 03/08/2017 to 31/10/2017
EMA/CHMP/356876/2017
