Paracetamol product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, paracetamol

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 - Revision 2

Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 2

Adopted Reference Number: EMA/CHMP/356877/2017 Rev. 2 Legal effective date: 01/01/2024

Document history - Revision 1

Draft paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 1

Draft: consultation closed Consultation dates: 04/04/2022 to 31/07/2022 Reference Number: EMA/CHMP/356877/2022 Rev.1 Summary:

This revision concerns defining what is meant by ‘comparable’ T_max as an additional main pharmacokinetic variable in the bioequivalence assessment section of the guideline.

Overview of comments received on 'Paracetamol oral use immediate release formulations product-specific bioequivalence guidance' (EMA/CHMP/356877/2022 Rev.1)

Reference Number: EMA/CHMP/758781/2022

Document history - First version

Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - First version

Adopted Reference Number: EMA/CHMP/356877/2017 Legal effective date: 01/08/2018 Summary:

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

Overview of comments received on 'Paracetamol oral use, immediate release formulations product-specific bioequivalence guidance' (EMA/CHMP/356877/2017) - First version

Reference Number: EMA/CHMP/729976/2017

Draft paracetamol oral use, immediate release formulations product-specific bioequivalence guidance - First version

Draft: consultation closed Consultation dates: 28/07/2017 to 31/10/2017 Reference Number: EMA/CHMP/356877/2017 Summary:

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