Carglumic acid product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, carglumic 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 effective version - Revision 1

Carglumic acid dispersible tablets 200 mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/151691/2025 Rev. 1Legal effective date: 01/10/2015

Document history - First version

Carglumic acid dispersible tablets 200 mg product-specific bioequivalence guidance

AdoptedReference Number: EMA/CHMP/315238/2014 Legal effective date: 01/10/2015Summary:

This document provides product-specific guidance on demonstration of bioequivalence of carglumic acid

Draft carglumic acid product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 15/11/2013 to 15/02/2014Reference Number: CHMP/PKWP/EMA/422457/2013Summary:

Carglumic acid product-specific bioequivalence guidance

Overview of comments received on 'Draft carglumic acid product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/116356/2014