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100   $a20120711d2012      uy         0
101 0 $aeng
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183   $acr
200 10$aSafe and effective medicines for children $epediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act /$fCommittee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); Board on Health Sciences Policy; Marilyn J. Field and Thomas F. Boat, editors
205   $a1st ed.
210   $aWashington $cNational Academies Press$d2012
215   $a1 online resource (432 p.)
300   $aDescription based upon print version of record.
311 08$a0-309-22549-3 
320   $aIncludes bibliographical references and index.
327   $a""Front Matter""; ""Acknowledgments""; ""Reviewers""; ""Preface""; ""Contents""; ""Boxes, Figures, and Tables""; ""Abbreviations and Acronyms""; ""Summary""; ""1 Introduction""; ""2 Children's Growth and Development and Pediatric Drug Studies""; ""3 Policy Framework for BPCA and PREA""; ""4 Ethical Issues in Pediatric Drug Studies""; ""5 Safety and Efficacy Assessments in Studies Conducted Under BPCA and PREA""; ""6 BPCA, PREA, and Drug Studies with Neonates""; ""7 Outcomes of Written Requests, Requirements, Studies, and Labeling Changes""; ""8 Pediatric Studies of Biologics""; ""References""
327   $a""Appendix A: Study Activities, Methods, and Public Meetings""""Appendix B: Dissemination of Information from Pediatric Studies Conducted Under BPCA and PREA""; ""Appendix C: Biologics in Pediatrics""; ""Appendix D: Biologics Studied and Not Studied in Children""; ""Appendix E: Written Requests for Studies of Pediatric Hypertension: Longitudinal Changes in FDA Specifications""; ""Appendix F: Committee and Staff Biographies""; ""Index""
330   $aThe Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
606   $aPediatric pharmacology
606   $aDrugs$xSafety measures
615  0$aPediatric pharmacology.
615  0$aDrugs$xSafety measures.
676   $a615.1083
701   $aField$b Marilyn J$g(Marilyn Jane)$01804195
701   $aBoat$b Thomas F$01803632
712 02$aInstitute of Medicine (U.S.).$bBoard on Health Sciences Policy.
712 02$aNational Academies Press (U.S.)
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910969490203321
996   $aSafe and effective medicines for children$94447366
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