Quality of oral modified release products

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/QWP/428693/2013
Published31/07/2014
Effective from01/02/2015
KeywordsOral dosage form, modified release
DescriptionThis document concerns quality aspects of dosage forms in which the release of active substance is modified. It only covers prolonged release oral dosage forms and delayed release oral dosage forms with the principle of gastro-resistance.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/02/2015–present


Published: 16/12/2014


Published: 14/08/2012
 

Superseded document

Concept paper


Adopted guideline

Published: 30/07/2010


In operation: 01/01/2000–31/01/2015


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