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Adaptive trials in paediatric development: dealing with heterogeneity and uncertainty in pharmacokinetic differences in children

AIMS: To assess whether an adaptive design in early clinical trials based on the paradigm of variable dosing and controlled exposure can provide better dosing recommendations compared with the standard fixed dose approach. METHODS: In a clinical trial simulation setting, a paediatric study was simul...

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Detalhes bibliográficos
Main Authors: Cella, Massimo, Danhof, Meindert, Della Pasqua, Oscar
Formato: Artigo
Idioma:Inglês
Publicado em: Blackwell Publishing Ltd 2012
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3630754/
https://ncbi.nlm.nih.gov/pubmed/22256787
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1365-2125.2012.04187.x
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