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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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Sonraí Bibleagrafaíochta
Main Authors: Cella, Massimo, Danhof, Meindert, Della Pasqua, Oscar
Formáid: Artigo
Teanga:Inglês
Foilsithe: Blackwell Publishing Ltd 2012
Ábhair:
Rochtain Ar Líne: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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