LEADER 03687nam 2200649Ia 450 001 9910820577203321 005 20240417004315.0 010 $a0-309-17865-7 010 $a1-281-80023-6 010 $a9786611800239 010 $a0-309-10743-1 035 $a(CKB)1000000000705282 035 $a(EBL)3378407 035 $a(SSID)ssj0000097237 035 $a(PQKBManifestationID)11122248 035 $a(PQKBTitleCode)TC0000097237 035 $a(PQKBWorkID)10113248 035 $a(PQKB)11492283 035 $a(MiAaPQ)EBC3378407 035 $a(Au-PeEL)EBL3378407 035 $a(CaPaEBR)ebr10255035 035 $a(CaONFJC)MIL180023 035 $a(OCoLC)923279359 035 $a(EXLCZ)991000000000705282 100 $a20080917d2008 ua 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aAddressing the barriers to pediatric drug development $eworkshop summary /$fCori 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 Academies 205 $a1st ed. 210 $aWashington, D.C. $cNational Academies Press$dc2008 215 $a1 online resource (65 p.) 300 $aDescription based upon print version of record. 311 $a0-309-10742-3 320 $aIncludes bibliographical references (p. 41-42). 327 $a""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"" 330 $aDecades 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. 606 $aDrugs$xTesting$xLaw and legislation$zUnited States 606 $aPediatric pharmacology$xLaw and legislation$zUnited States 606 $aPediatric pharmacology$xResearch$zUnited States 615 0$aDrugs$xTesting$xLaw and legislation 615 0$aPediatric pharmacology$xLaw and legislation 615 0$aPediatric pharmacology$xResearch 676 $a615.58083 701 $aButler$b Adrienne Stith$01593881 701 $aKnutsen$b Andrea$01712474 701 $aVanchieri$b Cori$01694095 712 02$aInstitute of Medicine (U.S.).$bForum on Drug Discovery, Development, and Translation. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910820577203321 996 $aAddressing the barriers to pediatric drug development$94104648 997 $aUNINA