Full
Outline
To establish a new pathway for the external validation of population pharmacokinetics (PPK) models based on real-world data, using aripiprazole in the treatment of schizophrenia as an example, and to explore a novel strategy for the clinical application of model-informed precision dosing (MIPD) and its feasibility.
A total of 101 patients with schizophrenia (1 178 blood drug concentration samples) were retrospectively enrolled at a class Ⅲ Grade A specialized hospital. Published PPK models of aripiprazole were identified by searching PubMed, Web of Science, and China National Knowledge Infrastructure (CNKI). Candidate models were evaluated using goodness-of-fit (R2) prediction error tests (PE, RPE%) to assess their predictive performance, and the model consistent with the characteristics of the blood concentration data was screened. Based on the selected PPK model, Monte Carlo simulation was performed to predict the steady-state plasma concentration of aripiprazole under different dosing regimens for individualized medication.
Three published PPK models of aripiprazole were included in this study. Goodness-of- fit and prediction error analyses showed that Model 3 had the best predictive performance. Based on Monte Carlo simulations with Model 3, plasma concentrations under 10 mg qd, 20 mg qd, and 30 mg qd regimens were ranked as IM > EM >UM in patients with the same body weight. For patients with the same CYP2D6 metabolic phenotype, plasma concentrations decreased with increasing body weight: 30 kg > 50 kg > 70 kg > 90 kg > 110 kg.
After validation with real-world data, the screened model with satisfactory predictive performance can be directly used in clinical practice to guide individualized medication and achieve model-informed precision dosing.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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