Nicholas L. Mills
To create preliminary physiologically based population models for Chinese patients with renal impairment and to assess the performance of new population models in predicting the effects of antibacterials cleared by the kidney. Chinese renal impairment patients' demographic information and physiological parameters were first gathered, and new population models were then built by recalibrating the relative demographic and physiological equation's coefficients. Second, Caucasian renal impairment population models created in Simcyp, Chinese healthy volunteers, and Caucasian healthy volunteers gathered and verified drugindependent parameters of ceftazidime, cefodizime, vancomycin, and cefuroxime. Finally, four antibacterial medication plasma concentrations in Chinese patients with renal impairment were predicted using the newly built demographic models. The primary pharmacokinetic parameters can be predicted by the new physiologically based pharmacokinetic (PBPK) population models, including In Chinese patients with mild, moderate, and severe renal impairment, the area under the plasma concentration-time curve extrapolated to infinity (AUCinf), renal clearance (CLr), and peak concentration (C max) of ceftazidime, cefodizime, vancomycin, and cefuroxime were determined after intravenous administrations with less than a twofold error. In comparison to the population models for Caucasian renal impairment and Chinese healthy volunteers, the forecasts' accuracy and precision increased. Four antimicrobial medicines were administered intravenously, and the first-step validation findings of the PBPK population models demonstrated adequate accuracy and precision. To support their applications on dose recommendations for Chinese patients with renal impairment, the population models still require further systematic validation through the use of more medications and scenarios in future investigations.
KeywordsChinese renal impairment patients, physiologically based pharmacokinetic model, predictive performance, renally cleared antibacterial drugs
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