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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

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.citation	British Journal of Clinical Pharmacology Vol. 75 Issue 4: pp. 1068-1080	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.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	journal article	es_ES
dc.identifier.doi	10.1111/j.1365-2125.2012.04406.x	es_ES
dc.identifier.idgrec	088387	es_ES