Carglumic acid product-specific bioequivalence guidance
Table of contents
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
- 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
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Carglumic acid dispersible tablets 200 mg product-specific bioequivalence guidance (PDF/77.93 KB)
Adopted
First published: 25/05/2016
Last updated: 25/05/2016
Legal effective date: 01/10/2015
EMA/CHMP/315238/2014 -
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Draft carglumic acid product-specific bioequivalence guidance (PDF/80.08 KB)
Draft: consultation closed
First published: 15/11/2013
Last updated: 15/11/2013
Consultation dates: 15/11/2013 to 15/02/2014
CHMP/PKWP/EMA/422457/2013 -
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Overview of comments received on 'Draft carglumic acid product-specific bioequivalence guidance' (PDF/106.16 KB)
First published: 10/04/2015
Last updated: 10/04/2015
EMA/CHMP/116356/2014