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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| 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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| Pubblicazione: | Washington, : National Academies Press, 2012 |
| Descrizione fisica: | 1 online resource (432 p.) |
| Disciplina: | 615.1083 |
| Soggetto topico: | Pediatric pharmacology |
| Drugs - Safety measures | |
| Soggetto genere / forma: | Electronic books. |
| Altri autori: |
FieldMarilyn J (Marilyn Jane)
BoatThomas F
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| Note generali: | Description based upon print version of record. |
| Nota di bibliografia: | Includes bibliographical references and index. |
| Nota di contenuto: | ""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"" | |
| Titolo autorizzato: | Safe and effective medicines for children |
| ISBN: | 1-283-63634-4 |
| 0-309-22550-7 | |
| Formato: | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione: | Inglese |
| Record Nr.: | 9910462065103321 |
| Lo trovi qui: | Univ. Federico II |
| Opac: | Controlla la disponibilità qui |