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Record Nr. |
UNINA9910462065103321 |
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Titolo |
Safe 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, editors |
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Pubbl/distr/stampa |
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Washington, : National Academies Press, 2012 |
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ISBN |
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1-283-63634-4 |
0-309-22550-7 |
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Descrizione fisica |
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1 online resource (432 p.) |
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Altri autori (Persone) |
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FieldMarilyn J (Marilyn Jane) |
BoatThomas F |
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Disciplina |
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Soggetti |
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Pediatric pharmacology |
Drugs - Safety measures |
Electronic books. |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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""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 |
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