Dissolution specification for generic oral immediate release products

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Reflection 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.


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First version

Current version

Reflection paper
 

Overview of comments

 

Draft reflection paper

Published: 15/08/2017

 

Published: 15/08/2017

 

Published: 15/08/2017

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