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

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Current effective version

Adopted guideline

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

Concept paper

Published: 04/05/2017


Deadline for comments: 31/07/2017

First version

Current version

Adopted guideline


Overview of comments

In operation: 01/01/2007-present


Published: 21/09/2006

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