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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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Библиографические подробности
Главные авторы: Cella, Massimo, Danhof, Meindert, Della Pasqua, Oscar
Формат: Artigo
Язык:Inglês
Опубликовано: Blackwell Publishing Ltd 2012
Предметы:
Online-ссылка: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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