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100   $a20120711d2012      uy             0
101 0 $aeng
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181   $ctxt
182   $cc
183   $acr
200 10$aSafe and effective medicines for children$b[electronic resource] $epediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act /$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
210   $aWashington $cNational Academies Press$d2012
215   $a1 online resource (432 p.)
300   $aDescription based upon print version of record.
311   $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""
606   $aPediatric pharmacology
606   $aDrugs$xSafety measures
608   $aElectronic books.
615  0$aPediatric pharmacology.
615  0$aDrugs$xSafety measures.
676   $a615.1083
701   $aField$b Marilyn J$g(Marilyn Jane)$0855032
701   $aBoat$b Thomas F$0910464
712 02$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   $a9910462065103321
996   $aSafe and effective medicines for children$92261335
997   $aUNINA