The Best Pharmaceuticals for Children Act and Pediatric Research Equity Act reach the age of majority-An oncology perspective.
Pediatr Blood Cancer
; 68(3): e28871, 2021 03.
Article
em En
| MEDLINE
| ID: mdl-33381908
ABSTRACT
The scarcity of adequate pediatric drug labeling information has long been problematic in the pediatric population, which may place children at risk for adverse drug effects. The ontogeny of infants, children, and adolescents over the course of the first two decades of life pose complex pharmacokinetic, dosing, administration, effectiveness, and toxicity-related questions that require specific investigation. Here, we review the history that led to the passage of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), and provide commentary on issues relevant to pediatric oncology now and in the future.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vigilância de Produtos Comercializados
/
Preparações Farmacêuticas
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
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Legislação de Medicamentos
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Neoplasias
Limite:
Child
/
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Pediatr Blood Cancer
Assunto da revista:
HEMATOLOGIA
/
NEOPLASIAS
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PEDIATRIA
Ano de publicação:
2021
Tipo de documento:
Article