03221nam 2200613Ia 450 991046206510332120200520144314.01-283-63634-40-309-22550-7(CKB)2670000000275065(EBL)3564276(SSID)ssj0000665841(PQKBManifestationID)11390001(PQKBTitleCode)TC0000665841(PQKBWorkID)10634808(PQKB)10095916(MiAaPQ)EBC3564276(PPN)175088071(Au-PeEL)EBL3564276(CaPaEBR)ebr10606357(CaONFJC)MIL394880(OCoLC)813285771(EXLCZ)99267000000027506520120711d2012 uy 0engurcn|||||||||txtccrSafe and effective medicines for children[electronic resource] pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act /Committee 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, editorsWashington National Academies Press20121 online resource (432 p.)Description based upon print version of record.0-309-22549-3 Includes bibliographical references and index.""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""""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""Pediatric pharmacologyDrugsSafety measuresElectronic books.Pediatric pharmacology.DrugsSafety measures.615.1083Field Marilyn J(Marilyn Jane)855032Boat Thomas F910464Institute of Medicine (U.S.).Board on Health Sciences Policy.National Academies Press (U.S.)MiAaPQMiAaPQMiAaPQBOOK9910462065103321Safe and effective medicines for children2261335UNINA