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

"The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and P...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores Corporativos: Institute of Medicine (U.S.). Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA), Institute of Medicine (U.S.). Board on Health Sciences Policy
Otros Autores: Field, Marilyn J. (Marilyn Jane), Boat, Thomas F.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press, 2012.
Temas:
Pediatric pharmacology > Research > United States.
Pediatric pharmacology > Law and legislation > United States.
Drugs > United States > Testing.
Pediatrics.
Drugs.
Child Health Services > legislation & jurisprudence
Drug Approval > legislation & jurisprudence
Drug Industry > legislation & jurisprudence
Drug Labeling > legislation & jurisprudence
Legislation, Drug
Patents as Topic > legislation & jurisprudence
Pediatrics
Pharmaceutical Preparations
Pharmacologie pédiatrique > Recherche > États-Unis.
Médicaments > États-Unis > Essais cliniques.
Pédiatrie.
Médicaments.
MEDICAL > Pharmacology.
Drugs
Drugs > Testing
United States
Acceso en línea:Texto completo
Descripción
Sumario:"The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children"--Publisher's description.
Descripción Física:1 online resource (xxiii, 408 pages) : illustrations (some color)
Bibliografía:Includes bibliographical references and index.
ISBN:0309225507
9780309225502
6613948802
9786613948809

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