Extrapolation of efficacy and safety in paediatric medicine development - Scientific guideline
Table of contents
This document proposes a framework for extrapolation of data from adults to children which could serve as a basis for regulatory decision making in planning and developing paediatric developments, including paediatric investigation plans.
Keywords: Paediatrics, extrapolation, medicine development, biostatistics, modelling and simulation
-
List item
Adopted reflection paper on the use of extrapolation in the development of medicines for paediatrics - Revision 1 (PDF/401.56 KB)
Adopted
First published: 30/10/2018
EMA/189724/2018 -
List item
Overview of comments received on ' Reflection paper on the use of extrapolation in the development of medicines for paediatrics ' (EMA/189724/2018) - Revision 1 (PDF/910.46 KB)
First published: 30/10/2018
EMA/696705/2018 -
List item
Draft reflection paper on the use of extrapolation in the development of medicines for paediatrics - Revision 1 (PDF/226.55 KB)
Draft: consultation closed
First published: 13/10/2017
Last updated: 13/10/2017
Consultation dates: 13/10/2017 to 14/01/2018
EMA/199678/2016 -
List item
Draft reflection paper on extrapolation of efficacy and safety in paediatric medicine development - First version (PDF/206.56 KB)
Draft
First published: 04/04/2016
Last updated: 04/04/2016
EMA/199678/2016