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- W44171488 abstract "Background: Tacrolimus is a potent immunosuppressant agent used to prevent and treat rejection in paediatric liver transplantation. Tacrolimus has a narrow therapeutic window and displays considerable between and within-subject pharmacokinetic variability, and pharmacokinetics seems to be changing markedly during the initial treatment. A model has been developed with the intent to capture this process. This model was used to suggest a revised initial dosing schedule and form the basis for a dose adaptation tool.Aim: To evaluate the predictability of the population model, in comparison to two previously published models(1, 2), using data collected from an independent group of paediatric liver patients.Methods: Retrospective data on tacrolimus dosage and concentrations were collected from the initial two weeks of therapy in 12 paediatric liver transplantation patients. Population predicted drug concentrations from the three models were compared to measured concentrations using samples drawn prior to TDM associated dosage adaption. Individual predicted drug concentrations based on all data were compared to measured concentrations. Individual predicted drug concentrations based on one or three prior measurements were also compared to measured concentrations. Model predictive performance was compared by calculation of MPE and RMSE. Visual evaluation of the predictive performance was performed with prediction corrected VPC (PC-VPC), where observed and simulated observations are normalized based on the population prediction, useful in application to TDM data (3).Results: The new population model was compared to the Sam and Staatz models through comparison of measured and population predicted concentrations based on samples drawn prior to TDM associated dosage adaption. Accuracy and precision expressed as MPE and RMSE was better for the proposed model compared to the Sam and Staatz model. Graphical diagnostics confirmed the increased predictive capability with the proposed model.Conclusion: The proposed pharmacokinetic model predicted the validation data set reasonably well, and was superior to the previously published models in this early post-transplantation phase." @default.
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- W44171488 date "2009-01-01" @default.
- W44171488 modified "2023-09-27" @default.
- W44171488 title "Evaluating the predictive performance of a population pharmacokinetic model of tacrolimus using a validation dataset based on sparse, adaptive-design data" @default.
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