Addressing the barriers to pediatric drug development workshop summary (National Academies Press, 2008)
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children--50 to 75 percent-- have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children
Includes bibliographical references
Introduction -- Response to drugs in various age groups -- Product labeling -- Organization of this summary -- Regulatory framework -- Best pharmaceuticals for children act -- Pediatric Research Equity Act -- Impact of pediatric drug legislation -- Discussion -- Current challenges in developing and prescribing drugs for children -- Barriers to pediatric drug development -- Formulations -- Dosing, bioavailability, and drug response -- Models for enhancing pediatric drug development -- Vaccine development in the United States -- The European Union's new regulatory approach -- The St. Jude's model for pediatric oncology drugs -- Challenges and opportunities for the future -- Systemic solutions -- Elimination of economic barriers -- Concluding thoughts