External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings
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External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings

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External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings

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dc.contributor.author Zhao, Wei es_ES
dc.contributor.author Kaguelidou, Florentia es_ES
dc.contributor.author Biran, Valérie es_ES
dc.contributor.author Zhang, Daolun es_ES
dc.contributor.author Allegaert, Karel es_ES
dc.contributor.author Capparelli, Edmund V es_ES
dc.contributor.author Holford, Nick es_ES
dc.contributor.author Kimura, Toshimi es_ES
dc.contributor.author Lo, Yoke-Lin es_ES
dc.contributor.author Peris Ribera, José Esteban es_ES
dc.contributor.author Thomson, Alison es_ES
dc.contributor.author Anker, John N es_ES
dc.contributor.author Fakhoury, May es_ES
dc.contributor.author Jacqz-Aigrain, Evelyne es_ES
dc.date.accessioned 2015-06-19T10:21:22Z
dc.date.available 2015-06-19T10:21:22Z
dc.date.issued 2012 es_ES
dc.identifier.uri http://hdl.handle.net/10550/44573
dc.description.abstract AimsVancomycin is one of the most evaluated antibiotics in neonates using modeling and simulation approaches. However no clear consensus on optimal dosing has been achieved. The objective of the present study was to perform an external evaluation of published models, in order to test their predictive performances in an independent dataset and to identify the possible study-related factors influencing the transferability of pharmacokinetic models to different clinical settings.MethodPublished neonatal vancomycin pharmacokinetic models were screened from the literature. The predictive performance of six models was evaluated using an independent dataset (112 concentrations from 78 neonates). The evaluation procedures used simulation-based diagnostics [visual predictive check (VPC) and normalized prediction distribution errors (NPDE)].ResultsDifferences in predictive performances of models for vancomycin pharmacokinetics in neonates were found. The mean of NPDE for six evaluated models were 1.35, −0.22, −0.36, 0.24, 0.66 and 0.48, respectively. These differences were explained, at least partly, by taking into account the method used to measure serum creatinine concentrations. The adult conversion factor of 1.3 (enzymatic to Jaffé) was tested with an improvement in the VPC and NPDE, but it still needs to be evaluated and validated in neonates. Differences were also identified between analytical methods for vancomycin.ConclusionThe importance of analytical techniques for serum creatinine concentrations and vancomycin as predictors of vancomycin concentrations in neonates have been confirmed. Dosage individualization of vancomycin in neonates should consider not only patients' characteristics and clinical conditions, but also the methods used to measure serum creatinine and vancomycin. es_ES
dc.source British Journal of Clinical Pharmacology Vol. 75 Issue 4: pp. 1068-1080 es_ES
dc.subject dosing regimen es_ES
dc.subject external evaluation es_ES
dc.subject neonates es_ES
dc.subject population pharmacokinetics es_ES
dc.subject serum creatinine es_ES
dc.subject vancomycin es_ES
dc.title External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings es_ES
dc.type info:eu-repo/semantics/article es_ES
dc.identifier.doi 10.1111/j.1365-2125.2012.04406.x es_ES
dc.identifier.idgrec 088387 es_ES

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