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

Aims: Vancomycin 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 predict...

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Main Authors: Zhao, Wei, Kaguelidou, Florentia, Biran, Valérie, Zhang, Daolun, Allegaert, Karel, Capparelli, Edmund V., Holford, Nick, Kimura, Toshimi, Lo, Yoke Lin, Peris, José-Esteban, Thomson, Alison, van den Anker, John N., Fakhoury, May, Jacqz-Aigrain, Evelyne
Format: Article
Published: Wiley 2013
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R Medicine
Online Access:http://eprints.um.edu.my/23072/
https://doi.org/10.1111/j.1365-2125.2012.04406.x
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spelling my.um.eprints.230722019-11-20T02:04:27Z http://eprints.um.edu.my/23072/ External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings Zhao, Wei Kaguelidou, Florentia Biran, Valérie Zhang, Daolun Allegaert, Karel Capparelli, Edmund V. Holford, Nick Kimura, Toshimi Lo, Yoke Lin Peris, José-Esteban Thomson, Alison van den Anker, John N. Fakhoury, May Jacqz-Aigrain, Evelyne R Medicine Aims: Vancomycin 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. Method: Published 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)]. Results: Differences 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. Conclusion: The 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. © 2012 The British Pharmacological Society. Wiley 2013 Article PeerReviewed Zhao, Wei and Kaguelidou, Florentia and Biran, Valérie and Zhang, Daolun and Allegaert, Karel and Capparelli, Edmund V. and Holford, Nick and Kimura, Toshimi and Lo, Yoke Lin and Peris, José-Esteban and Thomson, Alison and van den Anker, John N. and Fakhoury, May and Jacqz-Aigrain, Evelyne (2013) External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings. British Journal of Clinical Pharmacology, 75 (4). pp. 1068-1080. ISSN 0306-5251 https://doi.org/10.1111/j.1365-2125.2012.04406.x doi:10.1111/j.1365-2125.2012.04406.x
institution Universiti Malaya
building UM Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider Universiti Malaya
content_source UM Research Repository
url_provider http://eprints.um.edu.my/
topic R Medicine
spellingShingle R Medicine
Zhao, Wei
Kaguelidou, Florentia
Biran, Valérie
Zhang, Daolun
Allegaert, Karel
Capparelli, Edmund V.
Holford, Nick
Kimura, Toshimi
Lo, Yoke Lin
Peris, José-Esteban
Thomson, Alison
van den Anker, John N.
Fakhoury, May
Jacqz-Aigrain, Evelyne
External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings
description Aims: Vancomycin 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. Method: Published 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)]. Results: Differences 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. Conclusion: The 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. © 2012 The British Pharmacological Society.
format Article
author Zhao, Wei
Kaguelidou, Florentia
Biran, Valérie
Zhang, Daolun
Allegaert, Karel
Capparelli, Edmund V.
Holford, Nick
Kimura, Toshimi
Lo, Yoke Lin
Peris, José-Esteban
Thomson, Alison
van den Anker, John N.
Fakhoury, May
Jacqz-Aigrain, Evelyne
author_facet Zhao, Wei
Kaguelidou, Florentia
Biran, Valérie
Zhang, Daolun
Allegaert, Karel
Capparelli, Edmund V.
Holford, Nick
Kimura, Toshimi
Lo, Yoke Lin
Peris, José-Esteban
Thomson, Alison
van den Anker, John N.
Fakhoury, May
Jacqz-Aigrain, Evelyne
author_sort Zhao, Wei
title External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings
title_short External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings
title_full External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings
title_fullStr External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings
title_full_unstemmed External evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings
title_sort external evaluation of population pharmacokinetic models of vancomycin in neonates: the transferability of published models to different clinical settings
publisher Wiley
publishDate 2013
url http://eprints.um.edu.my/23072/
https://doi.org/10.1111/j.1365-2125.2012.04406.x
_version_ 1651867395628728320
score 13.211869

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