Extrapolation of efficacy and safety in medicine development

Current effective version

PDF iconConcept paper

Reference number EMA/129698/2012
Published 23/04/2013
Keywords Extrapolation, medicine development, biostatistics, modelling, simulation
Description This 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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