Pazopanib product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of pazopanib.
Keywords: Bioequivalence, generics, pazopanib
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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Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance (PDF/132.56 KB)
Adopted
First published: 03/01/2017
Last updated: 03/01/2017
Legal effective date: 01/07/2017
EMA/CHMP/154805/2016 -
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Overview of comments received on Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance (PDF/131.36 KB)
First published: 03/01/2017
Last updated: 03/01/2017
EMA/CHMP/693923/2016 -
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Draft Pazopanib film-coated tablet 200mg and 400mg product-specific bioequivalence guidance (PDF/77.18 KB)
Draft: consultation closed
First published: 02/05/2016
Last updated: 02/05/2016
Consultation dates: 02/05/2016 to 31/07/2016
EMA/CHMP/154805/2016