The European Medicines Agency Experience With Pediatric Dose Selection.
J Clin Pharmacol
; 61 Suppl 1: S22-S27, 2021 06.
Article
em En
| MEDLINE
| ID: mdl-34185894
ABSTRACT
Getting the right dose regimen for children and adolescents is important but poses great scientific, practical, and ethical challenges. At the same time, the availability of data in adults is a huge advantage and needs to be used optimally when designing studies in children and analyzing pediatric data. Furthermore, the processes of maturation and growth are always key when selecting doses for children. All the above make study adaptations and model-informed approaches imperative for dose exposure-response characterization and dose selection in children. This article summarizes the experience gained in the European Medicines Agency on this topic and proposes some general guiding principles for defining objectives, study designs, and methodology tools for pediatric dose selection.
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Base de dados:
MEDLINE
Assunto principal:
Pediatria
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Ensaios Clínicos como Assunto
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Medicamentos sob Prescrição
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Desenvolvimento de Medicamentos
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article