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

This 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.

Keywords: Juvenile animals, neonates, paediatric, non-clinical, clinical, pharmacology, pharmacokinetics, toxicology

Current version

Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications

Adopted Reference Number: EMEA/CHMP/SWP/169215/2005 Legal effective date: 01/08/2008

Document history

Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications

Adopted Reference Number: EMEA/CHMP/SWP/169215/2005 Legal effective date: 01/08/2008

Overview of comments received on draft guideline on the need for non-clinical testing in juvenile animals of human pharmaceuticals for paediatric indications

Reference Number: EMEA/425007/2007 Summary:

Overview of comments received on draft guideline on the need for non-clinical testing in juvenile animals of human pharmaceuticals for paediatric indications

Draft guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications

Draft: consultation closed Consultation dates: 11/10/2005 to 30/04/2006 Reference Number: EMEA/CHMP/SWP/169215/2005