Ursodeoxycholic acid product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, ursodeoxycholic acid

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 - effective from 01/01/2023

Ursodeoxycholic acid capsule 250 mg, film-coated tablet 150 mg, 300 mg, 450 mg, 500 mg, 600 mg and suspension 50 mg/ml (250 mg/5 ml) product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/559890/2021

Document history

Draft ursodeoxycholic acid capsule 250 mg, film-coated tablet 150 mg, 300 mg, 450 mg, 500 mg, 600 mg and suspension 50 mg/ml (250 mg/5 ml) product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 17/12/2021 to 31/03/2022Reference Number: EMA/CHMP/559890/2021Summary:

Comments should be provided using this template. The completed comments form should be sent to [e-mail].

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