Chapter 26 - Juvenile Animal Studies and Experience

Abstract

Nonclinical juvenile toxicity studies may need to be considered to support the use of pharmaceuticals in pediatric patients. If needed, they are generally conducted in rodents; nonhuman primates (NHPs) are used infrequently. At birth, NHPs are more developmentally advanced or as advanced as humans. For many of the organ systems that are not yet fully developed, the most rapid period of postnatal development occurs within the first 3-6-months and continues through to maturation but at a slower rate. When considering the need to conduct juvenile toxicity studies, the organ system of concern, the timing of greatest susceptibility, and the type of molecule need to be carefully considered. If sufficient information is available from developmental toxicity studies and/or general toxicities in young adults, additional studies in juvenile animals may not be need.