Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates.
Pediatr Res
; 81(5): 692-711, 2017 May.
Article
em En
| MEDLINE
| ID: mdl-28248319
ABSTRACT
The study of medications among pediatric patients has increased worldwide since 1997 in response to new legislation and regulations, but these studies have not yet adequately addressed the therapeutic needs of neonates. Additionally, extant guidance developed by regulatory agencies worldwide does not fully address the specificities of neonatal drug development, especially among extremely premature newborns who currently survive. Consequently, an international consortium from Canada, Europe, Japan, and the United States was organized by the Critical Path Institute to address the content of guidance. This group included neonatologists, neonatal nurses, parents, regulators, ethicists, clinical pharmacologists, specialists in pharmacokinetics, specialists in clinical trials and pediatricians working in the pharmaceutical industry. This group has developed a comprehensive, referenced White Paper to guide neonatal clinical trials of medicines - particularly early phase studies. Key points include the need to base product development on neonatal physiology and pharmacology while making the most of knowledge acquired in other settings; the central role of families in research; and the value of the whole neonatal team in the design, implementation and interpretation of studies. This White Paper should facilitate successful clinical trials of medicines in neonates by informing regulators, sponsors, and the neonatal community of existing good practice.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
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Preparações Farmacêuticas
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Fatores Biológicos
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Ensaios Clínicos como Assunto
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Cálculos da Dosagem de Medicamento
Tipo de estudo:
Etiology_studies
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Guideline
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Risk_factors_studies
Limite:
Humans
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Newborn
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article