Safe and effective medicines for children pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

Detalles Bibliográficos
Autor principal:	Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) (-)
Autores Corporativos:	Institute of Medicine (U.S.). Board on Health Sciences Policy, National Academies Press (U.S.)
Otros Autores:	Field, Marilyn J. (Marilyn Jane) (-), Boat, Thomas F.
Formato:	Libro electrónico
Idioma:	Inglés
Publicado:	Washington : National Academies Press 2012.
Edición:	1st ed
Materias:	Pediatric pharmacology. Drugs > Safety measures.
Ver en Biblioteca Universitat Ramon Llull:	https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820289906719

Tabla de Contenidos:

""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""

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