Role of pharmacokinetics in the development of medicinal products in the paediatric population

Current effective version

PDF icon<b>Adopted guideline</b>

Reference numberCHMP/EWP/147013/04
Effective from01/01/2007
KeywordsChildren, extrapolation, dose finding, maturation, age, adolescents, newborns, infants, toddlers, pharmacokinetics
DescriptionThis document provides advice on the use of pharmacokinetic studies in paediatric drug development and on methodological issues concerning pharmacokinetic studies in paediatric patients.

Document history

Revision 1

PDF iconConcept paper

Published: 04/05/2017

Deadline for comments: 31/07/2017

First version

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

In operation: 01/01/2007-present

Published: 21/09/2006

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