03690nam 2200637Ia 450 991078265510332120230721004539.00-309-17865-71-281-80023-697866118002390-309-10743-1(CKB)1000000000705282(EBL)3378407(SSID)ssj0000097237(PQKBManifestationID)11122248(PQKBTitleCode)TC0000097237(PQKBWorkID)10113248(PQKB)11492283(MiAaPQ)EBC3378407(Au-PeEL)EBL3378407(CaPaEBR)ebr10255035(CaONFJC)MIL180023(OCoLC)923279359(EXLCZ)99100000000070528220080917d2008 ua 0engur|n|---|||||txtccrAddressing the barriers to pediatric drug development[electronic resource] workshop summary /Cori Vanchieri, Adrienne Stith Butler, and Andrea Knutsen, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National AcademiesWashington, D.C. National Academies Pressc20081 online resource (65 p.)Description based upon print version of record.0-309-10742-3 Includes bibliographical references (p. 41-42).""Reviewers""; ""Contents""; ""Summary""; ""1 Introduction""; ""2 Regulatory Framework""; ""3 Current Challenges in Developing and Prescribing Drugs for Children""; ""4 Models for Enhancing Pediatric Drug Development""; ""5 Challenges and Opportunities for the Future""; ""References""; ""Appendixes""; ""Appendix A: Workshop Agenda""; ""Appendix B: Speaker Biographies""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.DrugsTestingLaw and legislationUnited StatesPediatric pharmacologyLaw and legislationUnited StatesPediatric pharmacologyResearchUnited StatesDrugsTestingLaw and legislationPediatric pharmacologyLaw and legislationPediatric pharmacologyResearch615.58083Butler Adrienne Stith1470578Knutsen Andrea1578442Vanchieri Cori1546613Institute of Medicine (U.S.).Forum on Drug Discovery, Development, and Translation.MiAaPQMiAaPQMiAaPQBOOK9910782655103321Addressing the barriers to pediatric drug development3857766UNINA