ArticleFrontiers in pharmacology2020
Impact of Inaccurate Documentation of Sampling and Infusion Time in Model-Informed Precision Dosing.
Article in Frontiers in pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
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25 citing papers in PubMed, 39 citations in OpenAlex.
- A qualitative process evaluation of a clinical trial on bedside model-informed precision dosing of vancomycin in critically ill children.International journal of clinical pharmacy · 2026Article
- Informing Sampling Design for Lung Distribution Studies Using a Pulmonary Population Minimal PBPK Model.Clinical pharmacokinetics · 2026Article
- Development and evaluation of automated screening algorithms for pre-analytical errors in pharmacokinetic data: a simulation-based study.Translational and clinical pharmacology · 2026Article
- Impact of Administration Time Errors on Clearance Estimation in Pharmacokinetic Analyses.Clinical and translational science · 2025Article
- Prediction of Vancomycin Area Under the Curve With Trough Concentrations Only: Performance Evaluation of Pediatric Population Pharmacokinetic Models.The Journal of infectious diseases · 2025Article
- Interoccasion variability in population pharmacokinetic models: identifiability, influence, interdependencies and derived study design recommendations.Journal of pharmacokinetics and pharmacodynamics · 2025Article
- Leveraging Clinical Data to Enhance the Performance Evaluation of Ceftriaxone Population Pharmacokinetic Models in Children.Clinical pharmacokinetics · 2025Article
- Dose Individualisation of Antimicrobials from a Pharmacometric Standpoint: The Current Landscape.Drugs · 2024Review
- Evaluation and optimization of sample size of neonates and infants for pediatric clinical studies on cefiderocol using a model-based approach.Pharmacology research & perspectives · 2024Article
- Determination of a vancomycin nephrotoxicity threshold and assessment of target attainment in hematology patients.Pharmacology research & perspectives · 2024Article
- Model-informed precision dosing of vancomycin for rapid achievement of target area under the concentration-time curve: A simulation study.Clinical and translational science · 2023Article
- Evaluation of Vancomycin Area Under the Concentration-Time Curve Predictive Performance Using Bayesian Modeling Software With and Without Peak Concentration: An Academic Hospital Experience for Adult Patients Without Renal Impairment.Annals of laboratory medicine · 2023Article
- Towards Model-Informed Precision Dosing of Voriconazole: Challenging Published Voriconazole Nonlinear Mixed-Effects Models with Real-World Clinical Data.Clinical pharmacokinetics · 2023Article
- Towards model-informed precision dosing of piperacillin: multicenter systematic external evaluation of pharmacokinetic models in critically ill adults with a focus on Bayesian forecasting.Intensive care medicine · 2023Article
- Plasma and Cerebrospinal Fluid Population Pharmacokinetics of Vancomycin in Patients with External Ventricular Drain.Antimicrobial agents and chemotherapy · 2023Observational
- Investigating the contribution of residual unexplained variability components on bias and imprecision of parameter estimates in population pharmacokinetic mixed-effects modeling.Journal of pharmacokinetics and pharmacodynamics · 2023Article
- Systematic Evaluation of Voriconazole Pharmacokinetic Models without Pharmacogenetic Information for Bayesian Forecasting in Critically Ill Patients.Pharmaceutics · 2022Article
- Model Re-Estimation: An Alternative for Poor Predictive Performance during External Evaluations? Example of Gentamicin in Critically Ill Patients.Pharmaceutics · 2022Article
- Optimized sampling to estimate vancomycin drug exposure: Comparison of pharmacometric and equation-based approaches in a simulation-estimation study.CPT: pharmacometrics & systems pharmacology · 2022Article
- Ciprofloxacin in Patients Undergoing Extracorporeal Membrane Oxygenation (ECMO): A Population Pharmacokinetic Study.Pharmaceutics · 2022Article
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRoutine clinical TDM data is often used to develop population pharmacokinetic (PK) models, which are applied in turn for model-informed precision dosing. The impact of uncertainty in documented sampling and infusion times in population PK modeling and model-informed precision dosing have not yet been systematically evaluated. The aim of this study was to investigate uncertain documentation of (i) sampling times and (ii) infusion rate exemplified with two anti-infectives.
methodsA stochastic simulation and estimation study was performed in NONMEM
resultsOn the population level, the estimates of the proportional residual error (prop.-err.) and the interindividual variability (IIV) on the central volume of distribution (V1) were most affected by erroneous records in the sampling and infusion time (e.g. rBias of prop.-err.: 75.5% vs. 183% (meropenem) and 10.1% vs. 109% (caspofungin) for ± 5 vs. ± 30 min, respectively). On the individual level, the rBias of the planned scenario for the typical values V1, Q and V2 increased with increasing uncertainty in time, while CL, AUC and elimination half-life were least affected. Meropenem as a short half-life drug (~1 h) was more affected than caspofungin (~ 9-11 h). The misspecified model provided biased PK/PD target information (e.g. falsely overestimated time above MIC (T > MIC) when true T > MIC was <0.4 and thus patients at risk of undertreatment), while the accurate model gave precise estimates of the indices across all simulated patients.
conclusionsEven 5-minute-uncertainties caused bias and significant imprecision of primary population and individual PK parameters. Thus, our results underline the importance of accurate documentation of time.
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