Need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications

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Current effective version

Adopted guideline

Reference numberCHMP/SWP/169215/05
Effective from01/08/2008
KeywordsJuvenile animals, neonates, paediatric, non-clinical, clinical, pharmacology, pharmacokinetics, toxicology
DescriptionThis document provides guidance on studies in juvenile animals in the non-clinical safety evaluation of medicinal products for paediatric use. It outlines potential safety concerns that cannot be adequately assessed in the adult population, in standard non-clinical studies, or in clinical trials.

Document history

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

In operation: 01/08/2008–present

Published: 26/05/2009

Published: 29/09/2005

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