Opportunities for Pediatric Drug Development: The Knowledge Bridge from Basic Science to Clinical Application

Nineteen hundred and ninety five presents a unique opportunity in the history of pediatric therapeutics. Major new initiatives from the Food and Drug Administration, the National Institute of Child Health and Human Development, and the American Academy of Pediatrics have focused attention on the need to assure safe, effective drug therapy for children. At the same time, advances in understanding the mechanisms of drug clearance and response in the human population, and growing investigation of the ontogeny of those mechanisms in children hold the promise for evolving new paradigms for the safe/efficient study of new drugs in children. A major challenge to the academic community, industry, and regulatory agencies is to take maximum advantage of the explosion of this new knowledge and to apply it to real world pediatric drug therapy.