Extrapolation of efficacy and safety in medicine development - Scientific guideline

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

Current effective version

Concept paper on extrapolation of efficacy and safety in medicine development

Adopted Reference Number: EMA/129698/2012 Summary:

The concept paper is intended 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

Overview of comments received on 'Concept paper on extrapolation of efficacy and safety in medicine development'

Adopted Reference Number: EMA/184035/2013

Concept paper on extrapolation of efficacy and safety in medicine development

Adopted Reference Number: EMA/129698/2012 Summary:

The concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation.