Extrapolation of efficacy and safety in medicine development - Scientific guideline
Table of contents
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.
Keywords: Extrapolation, medicine development, biostatistics, modelling, simulation
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Overview of comments received on 'Concept paper on extrapolation of efficacy and safety in medicine development' (PDF/489.57 KB)
Adopted
First published: 23/04/2013
Last updated: 23/04/2013
EMA/184035/2013 -
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Concept paper on extrapolation of efficacy and safety in medicine development (PDF/103.57 KB)
Adopted
First published: 23/04/2013
Last updated: 23/04/2013
EMA/129698/2012