Dissolution specification for generic oral immediate release products

Current effective version

PDF iconReflection paper

Reference numberEMA/CHMP/CVMP/QWP/336031/2017
Published15/08/2017
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.


Document history

First version

Current version

PDF iconReflection paper

PDF iconOverview of comments

PDF iconDraft reflection paper

Published: 15/08/2017

Published: 15/08/2017

Published: 15/08/2017

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