Metformin product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of Metformin immediate-release film-coated tablets 500, 850 and 1000 mg.

Keywords: Bioequivalence, generics, Metformin

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

Metformin immediate-release film-coated tablets 500, 850 and 1000 mg and 1000 mg/5ml oral solution product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/CHMP/591346/2022 Rev. 1 Legal effective date: 01/12/2025

Document history

Draft metformin immediate-release film-coated tablets 500, 850 and 1000 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 22/06/2023 to 30/09/2023 Reference Number: EMA/CHMP/591346/2022

Metformin immediate-release film-coated tablets 500, 850 and 1000 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/591346/2022 Legal effective date: 01/06/2024

Related content

• Product-specific bioequivalence guidance
• Investigation of bioequivalence