Prasugrel product-specific bioequivalence guidance
This document provides product-specific guidance on the demonstration of the bioequivalence of prasugrel.
Keywords: Bioequivalence, generics, prasugrel
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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Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance (PDF/86.88 KB)
Adopted
First published: 26/06/2018
Last updated: 26/06/2018
Legal effective date: 01/12/2018
EMA/CHMP/158772/2016/Rev.1 -
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Overview of comments received on 'Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance' (PDF/283.43 KB)
First published: 26/06/2018
Last updated: 26/06/2018
EMA/CHMP/644911/2017 -
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Draft prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance - Revision 1 (PDF/82.16 KB)
Draft: consultation closed
First published: 03/08/2017
Last updated: 03/08/2017
Consultation dates: 03/08/2017 to 31/10/2017
EMA/CHMP/158772/2016/Rev. 1
-
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Prasugrel film-coated tablets 5 and 10 mg product-specific bioequivalence guidance (PDF/78.16 KB)
Adopted
First published: 25/05/2016
Last updated: 01/11/2016
Legal effective date: 01/11/2016
EMA/CHMP/158772/2016 -
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Overview of comments received on 'Prasugrel film-coated tablets 5 and 10 mg product-specific bioequivalence guidance' (PDF/129.93 KB)
First published: 07/04/2016
Last updated: 07/04/2016
EMA/CHMP/162888/2016 -
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Draft prasugrel film-coated tablets 5 and 10 mg product-specific bioequivalence guidance (PDF/81 KB)
Draft: consultation closed
First published: 15/07/2015
Last updated: 15/07/2015
Consultation dates: 15/07/2015 to 01/11/2015
EMA/CHMP/PKWP/36761/2015