Cholic acid product-specific bioequivalence guidance
Table of contents
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
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- Cmax: maximum plasma concentration
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Overview of comments received on 'Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance’ (PDF/108.13 KB)
First published: 03/08/2018
Last updated: 03/08/2018
EMA/CHMP/395071/2018 -
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Draft cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance (PDF/77.39 KB)
Draft: consultation closed
First published: 31/01/2018
Last updated: 31/01/2018
Consultation dates: 31/01/2018 to 30/04/2018
EMA/CHMP/800759/2017