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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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| Autori principali: | , , |
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| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
Blackwell Publishing Ltd
2012
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| Soggetti: | |
| Accesso online: | 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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