Dissolution specification for generic oral immediate release products

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Reflection paper


Reference numberEMA/CHMP/CVMP/QWP/336031/2017
KeywordsDissolution specification, generic, oral immediate release product
DescriptionThis 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.

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Reflection paper

Overview of comments


Draft reflection paper

Published: 15/08/2017


Published: 15/08/2017


Published: 15/08/2017

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