Cholic acid product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of cholic acid capsules 50 mg and 250 mg.

Keywords: Bioequivalence, generics, cholic 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 1 January 2026

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/188360/2025 Rev. 1 Legal effective date: 01/01/2026

First version

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/800759/2017 Legal effective date: 01/02/2019 Summary:

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Overview of comments received on 'Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance’

Reference Number: EMA/CHMP/395071/2018 Summary:

Overview of comments received on 'Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance’

Draft cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 31/01/2018 to 30/04/2018 Reference Number: EMA/CHMP/800759/2017 Summary:

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance