03687nam 2200649Ia 450 991082057720332120240417004315.00-309-17865-71-281-80023-697866118002390-309-10743-1(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 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 Academies1st ed.Washington, 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 Stith1593881Knutsen Andrea1712474Vanchieri Cori1694095Institute of Medicine (U.S.).Forum on Drug Discovery, Development, and Translation.MiAaPQMiAaPQMiAaPQBOOK9910820577203321Addressing the barriers to pediatric drug development4104648UNINA