Extrapolation of efficacy and safety in paediatric medicine development

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Current version

Revision 1 - Draft reflection paper
Open for consultation

Deadline for comments: 14/01/2018

Reference numberEMA/199678/2016
KeywordsPaediatrics, extrapolation, medicine development, biostatistics, modelling and simulation

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.

Document history

Revision 1
Current version

Draft reflection paper - Revision 1


Published: 13/10/2017
Deadline for comments: 14/01/2018
First versionDraft reflection paperIn operation: 30/10/2005–29/04/2015

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