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
Tabla de Contenidos:
  • Introduction
  • Children's growth and development and pediatric drug studies
  • Policy framework for BPCA and PREA
  • Ethical issues in pediatric drug studies
  • Safety and efficacy assessment in studies conducted under BPCA and PREA
  • BPCA, PREA, and drug studies with neonates
  • Outcomes of written requests, requirements, studies, and labelling changes
  • Pediatric studies of biologics.

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