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

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

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