Extrapolation of efficacy and safety in medicine development

Current effective version

PDF iconConcept paper

Reference numberEMA/129698/2012
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.

Document history

First version

Current version

PDF iconConcept paper


PDF iconOverview of commnets


PDF iconDraft concept paper

Published: 23/04/2013


Published: 23/04/2013


Published: 29/06/2012

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