Dissolution specification for generic oral immediate release products - Scientific guideline
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This document discusses the suitability of the dissolution method and the specifications for in vitro dissolution of orally administered generic drug products with immediate release characteristics.
Keywords: Dissolution specification, generic, oral immediate release product
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Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action - First version (PDF/156.9 KB)
First published: 15/08/2017
Last updated: 15/08/2017
EMA/CHMP/CVMP/QWP/336031/2017 -
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Overview of comments received on 'Draft reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action' - First version (PDF/751.96 KB)
First published: 15/08/2017
Last updated: 15/08/2017
EMA/CHMP/CVMP/QWP/257305/2017 -
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Draft reflection paper on the dissolution specification for generic oral immediate release products - First version (PDF/146.32 KB)
Draft: consultation closed
First published: 13/05/2016
Last updated: 13/05/2016
Consultation dates: 13/05/2016 to 13/08/2016
EMA/CHMP/CVMP/QWP/37330/2016