External evaluation of the predictive performance of seven population pharmacokinetic models for phenobarbital in neonates

2021 ◽  
Author(s):  
Sunae Ryu ◽  
Woo Jin Jung ◽  
Zheng Jiao ◽  
Jung‐Woo Chae ◽  
Hwi‐yeol Yun
Keyword(s):  
Predictive Performance ◽  
Population Pharmacokinetic ◽  
Pharmacokinetic Models ◽  
External Evaluation

scholarly journals External Evaluation of Population Pharmacokinetic Models and Bayes-Based Dosing of Infliximab

Pharmaceutics ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1191
Author(s):  
Celine Konecki ◽  
Catherine Feliu ◽  
Yoann Cazaubon ◽  
Delphine Giusti ◽  
Marcelle Tonye-Libyh ◽  
...  
Keyword(s):  
Goodness Of Fit ◽  
Inflammatory Diseases ◽  
Plasma Concentrations ◽  
Population Pharmacokinetic ◽  
Pharmacokinetic Models ◽  
External Evaluation ◽  
Immunomodulatory Treatment ◽  
Weighted Residuals ◽  
Prediction Distribution ◽  
Target Plasma

Despite the well-demonstrated efficacy of infliximab in inflammatory diseases, treatment failure remains frequent. Dose adjustment using Bayesian methods has shown in silico its interest in achieving target plasma concentrations. However, most of the published models have not been fully validated in accordance with the recommendations. This study aimed to submit these models to an external evaluation and verify their predictive capabilities. Eight models were selected for external evaluation, carried out on an independent database (409 concentrations from 157 patients). Each model was evaluated based on the following parameters: goodness-of-fit (comparison of predictions to observations), residual error model (population weighted residuals (PWRES), individual weighted residuals (IWRES), and normalized prediction distribution errors (NPDE)), and predictive performances (prediction-corrected visual predictive checks (pcVPC) and Bayesian simulations). The performances observed during this external evaluation varied greatly from one model to another. The eight evaluated models showed a significant bias in population predictions (from −7.19 to 7.38 mg/L). Individual predictions showed acceptable bias and precision for six of the eight models (mean error of −0.74 to −0.29 mg/L and mean percent error of −16.6 to −0.4%). Analysis of NPDE and pcVPC confirmed these results and revealed a problem with the inclusion of several covariates (weight, concomitant immunomodulatory treatment, presence of anti-drug antibodies). This external evaluation showed satisfactory results for some models, notably models A and B, and highlighted several prospects for improving the pharmacokinetic models of infliximab for clinical-biological application.

External evaluation of published population pharmacokinetic models of polymyxin B

2021 ◽  
Author(s):  
Ya-qian Li ◽  
Kai-feng Chen ◽  
Jun-jie Ding ◽  
Hong-yi Tan ◽  
Nan Yang ◽  
...  
Keyword(s):  
Polymyxin B ◽  
Population Pharmacokinetic ◽  
Pharmacokinetic Models ◽  
External Evaluation

scholarly journals External evaluation of population pharmacokinetic models for ciclosporin in adult renal transplant recipients

2017 ◽  
Vol 84 (1) ◽  
pp. 153-171 ◽  
Author(s):  
Jun-Jun Mao ◽  
Zheng Jiao ◽  
Hwi-Yeol Yun ◽  
Chen-Yan Zhao ◽  
Han-Chao Chen ◽  
...  
Keyword(s):  
Renal Transplant ◽  
Population Pharmacokinetic ◽  
Renal Transplant Recipients ◽  
Pharmacokinetic Models ◽  
Transplant Recipients ◽  
External Evaluation

scholarly journals External validation of the predictive performance of population pharmacokinetic models for phenobarbital in pediatric patients

2020 ◽  
Author(s):  
Sunae Ryu ◽  
Woo Jin Jung ◽  
Zheng Jiao ◽  
Jung Woo Chae ◽  
Hwi-yeol Yun
Keyword(s):  
External Validation ◽  
Predictive Performance ◽  
Validation Dataset ◽  
Therapeutic Drug ◽  
Population Pharmacokinetic ◽  
Pharmacokinetic Models ◽  
Bayesian Forecasting ◽  
Predictive Capability ◽  
Young Infants ◽  
Simulation Based

Aim: Several studies have reported population pharmacokinetic models for phenobarbital (PB), but the predictive performance of these models has not been well documented. This study aims to do external validation of the predictive performance in published pharmacokinetic models. Methods: Therapeutic drug monitoring data collected in neonates and young infants treated with PB for seizure control, was used for external validation. A literature review was conducted through PubMed to identify population pharmacokinetic models. Prediction- and simulation-based diagnostics, and Bayesian forecasting were performed for external validation. The incorporation of size or maturity functions into the published models was also tested for prediction improvement. Results: A total of 79 serum concentrations from 28 subjects were included in the external validation dataset. Seven population pharmacokinetic studies of PB were selected for evaluation. The model by Voller et al. [27] showed the best performance concerning prediction-based evaluation. In simulation-based analyses, the normalized prediction distribution error of two models (those of Shellhaas et al. [24] and Marsot et al. [25]) obeyed a normal distribution. Bayesian forecasting with more than one observation improved predictive capability. Incorporation of both allometric size scaling and maturation function generally enhanced the predictive performance, but with marked improvement for the adult pharmacokinetic model. Conclusion: The predictive performance of published pharmacokinetic models of PB was diverse, and validation may be necessary to extrapolate to different clinical settings. Our findings suggest that Bayesian forecasting improves the predictive capability of individual concentrations for pediatrics.

scholarly journals Assessing Predictive Performance of Published Population Pharmacokinetic Models of Intravenous Tobramycin in Pediatric Patients

2016 ◽  
Vol 60 (6) ◽  
pp. 3407-3414 ◽  
Author(s):  
Celeste Bloomfield ◽  
Christine E. Staatz ◽  
Sean Unwin ◽  
Stefanie Hennig
Keyword(s):  
Pediatric Patients ◽  
Predictive Performance ◽  
Population Pharmacokinetic ◽  
Pharmacokinetic Data ◽  
Pharmacokinetic Models ◽  
Simulation Based ◽  
Disposition Model ◽  
Relationship Of ◽  
Mean Square Errors ◽  
Pharmacokinetic Behavior

Several population pharmacokinetic models describe the dose-exposure relationship of tobramycin in pediatric patients. Before the implementation of these models in clinical practice for dosage adjustment, their predictive performance should be externally evaluated. This study tested the predictive performance of all published population pharmacokinetic models of tobramycin developed for pediatric patients with an independent patient cohort. A literature search was conducted to identify suitable models for testing. Demographic and pharmacokinetic data were collected retrospectively from the medical records of pediatric patients who had received intravenous tobramycin. Tobramycin exposure was predicted from each model. Predictive performance was assessed by visual comparison of predictions to observations, by calculation of bias and imprecision, and through the use of simulation-based diagnostics. Eight population pharmacokinetic models were identified. A total of 269 concentration-time points from 41 pediatric patients with cystic fibrosis were collected for external evaluation. Three models consistently performed best in all evaluations and had mean errors ranging from −0.4 to 1.8 mg/liter, relative mean errors ranging from 4.9 to 29.4%, and root mean square errors ranging from 47.8 to 66.9%. Simulation-based diagnostics supported these findings. Models that allowed a two-compartment disposition generally had better predictive performance than those that used a one-compartment disposition model. Several published models of the pharmacokinetics of tobramycin showed reasonable low levels of bias, although all models seemed to have some problems with imprecision. This suggests that knowledge of typical pharmacokinetic behavior and patient covariate values alone without feedback concentration measurements from individual patients is not sufficient to make precise predictions.

External evaluation of population pharmacokinetic models for continuous administration of meropenem in critically ill adult patients

2020 ◽  
Vol 76 (9) ◽  
pp. 1281-1289
Author(s):  
YL. Wang ◽  
R. Guilhaumou ◽  
O. Blin ◽  
L. Velly ◽  
Amélie Marsot
Keyword(s):  
Critically Ill ◽  
Adult Patients ◽  
Population Pharmacokinetic ◽  
Pharmacokinetic Models ◽  
External Evaluation ◽  
Continuous Administration

scholarly journals External Evaluation of Population Pharmacokinetic Models of Imatinib in Adults Diagnosed with Chronic Myeloid Leukaemia

2021 ◽  
Author(s):  
Álvaro Corral Alaejos ◽  
Aránzazu Zarzuelo Castañeda ◽  
Silvia Jiménez Cabrera ◽  
Fermín Sánchez‐Guijo ◽  
María José Otero ◽  
...  
Keyword(s):  
Chronic Myeloid Leukaemia ◽  
Myeloid Leukaemia ◽  
Population Pharmacokinetic ◽  
Pharmacokinetic Models ◽  
External Evaluation

scholarly journals Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease

Pharmaceutics ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1244
Author(s):  
Silvia Marquez-Megias ◽  
Amelia Ramon-Lopez ◽  
Patricio Más-Serrano ◽  
Marcos Diaz-Gonzalez ◽  
Maria Remedios Candela-Boix ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Predictive Performance ◽  
Stochastic Simulations ◽  
University Hospital ◽  
Pharmacokinetic Parameters ◽  
Population Pharmacokinetic ◽  
Pharmacokinetic Models ◽  
Inflammatory Bowel ◽  
The Individual

Adalimumab is a monoclonal antibody used for inflammatory bowel disease. Due to its considerably variable pharmacokinetics, the loss of response and the development of anti-antibodies, it is highly recommended to use a model-informed precision dosing approach. The aim of this study is to evaluate the predictive performance of different population-pharmacokinetic models of adalimumab for inflammatory bowel disease to determine the pharmacokinetic model(s) that best suit our population to use in the clinical routine. A retrospective observational study with 134 patients was conducted at the General University Hospital of Alicante between 2014 and 2019. Model adequacy of each model was evaluated by the distribution of the individual pharmacokinetic parameters and the NPDE plots whereas predictive performance was assessed by calculating bias and precision. Moreover, stochastic simulations were performed to optimize the maintenance doses in the clinical protocols, to reach the target of 8 mg/L in at least 75% of the population. Two population-pharmacokinetic models were selected out of the six found in the literature which performed better in terms of adequacy and predictive performance. The stochastic simulations suggested the benefits of increasing the maintenance dose in protocol to reach the 8 mg/L target.

Predictive performance of reported population pharmacokinetic models of vancomycin in Chinese adult patients

2013 ◽  
Vol 38 (6) ◽  
pp. 480-489 ◽  
Author(s):  
C. Deng ◽  
T. Liu ◽  
K. Wu ◽  
S. Wang ◽  
L. Li ◽  
...  
Keyword(s):  
Predictive Performance ◽  
Adult Patients ◽  
Population Pharmacokinetic ◽  
Pharmacokinetic Models ◽  
Chinese Adult
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