Extrapolation of efficacy and safety in medicine development

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Concept paper

Reference numberEMA/129698/2012
Published23/04/2013
KeywordsExtrapolation, medicine development, biostatistics, modelling, simulation
DescriptionThis document aims to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation.


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First version

Current version

Concept paper


Overview of commnets


Draft concept paper

Published: 23/04/2013


Published: 23/04/2013


Published: 29/06/2012


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