Comparative Organ System Development: Introduction

Birth Defects Research Part B: Developmental and Reproductive Toxicology. 2003;68(2):85

It is well known that development continues postnatally in both humans and animals. There has also been recent concern in the scientific and regulatory arenas that improved safety assessments for pediatric populations are needed. The need for the evaluation of potential toxicity in immature animals has been raised (WHO, 1986; Guzelian et al., 1992; EPA, 1999). Regulatory requirements for hazard and risk assessment specific to the immature individual have received a lot more attention within the past several years (Kimmel and Makris, 2001). For pesticides, regulatory attention has included the 1996 Food Quality Protection Act (FQPA), an amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), which specifically mandates a focus on children's health risks from pesticide exposure. For pharmaceuticals, the FDA Center for Drug Evaluation and Research (CDER) developed regulations requiring the assessment for use in pediatric patients (FDA, 1998a,b), including functional evaluations depending on the intended use, pharmacologic activity of the drug, and expected target organ or system. In order to comply with the FDA's and EPA's regulations, studies in juvenile animals are being initiated. However, as the increase in studies in young animals continues, it has become clear that there are many challenges to the design, conduct, and interpretation of these new data.

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