Pharmaceutical Industry in Pediatric Drug Development: Partners and Collaborators With Academia and the FDA

摘要

The history of drug development is clearly one of neglecting the specific needs of children by assuming, incorrectly, that adult data can be directly applied to children. Shirkey has described infants and children as "therapeutic orphans," attesting to the fact that drugs are not often developed for their specific and unmet medical needs (1). Drugs are used in children every day with little guidance on appropriate dosing based on a lack of understanding of the pathobiology, metabolic and physiological differences, and developmental changes that characterize the differences from the adult. Adverse drug reactions or decreased efficacy in children occurs because of inherent over- or underdosing and unrecognized drug-drug interactions in the pediatric patient.