Preliminary physiologically based pharmacokinetic modeling of renally cleared drugs in Chinese pregnant women
Preliminary physiologically based pharmacokinetic modeling of renally cleared drugs in Chinese pregnant women
复制标题
中国孕妇经肾清除药物的初步生理药代动力学模型
DOI：
10.1002/bdd.2243
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发表时间：
2020-06
影响因子：
2.1
通讯作者：
Zhou Tianyan
中科院分区：
文献类型：
--
作者：
Song Ling;Yu Zhiheng;Xu Yifan;Li Xiaobei;Liu Xuanlin;Liu Dongyang;Zhou Tianyan
目的建立并验证中国孕妇基于生理的药代动力学（PBPK）模型。该模型用于预测6种主要通过肾脏清除的药物的母体药代动力学（PK）。方法基于SimCYP高加索妊娠人群数据集，根据中国（或日本）孕妇的生理参数，更新几个关键参数和方程，构建初步的中国妊娠人群。通过白种人非妊娠人群、白种人妊娠人群和中国非妊娠人群的PBPK模型，验证6种肾脏清除药物的药物特异性参数。将中国孕妇初步人群与药物特异性参数相结合，建立中国孕妇PBPK初步模型。通过将这6种药物的母体PK预测值与文献中观察到的体内数据进行比较，验证了该模型。结果初步建立的中国孕妇群体PBPK模型成功预测了6种靶药在不同妊娠阶段的PK。预测的血浆浓度和时间曲线与观测数据吻合较好，大多数预测的PK参数与观测数据的误差在2倍以内。结论：初步建立的中国孕妇PBPK模型为预测中国孕妇6种主要肾清除药物的母体PK提供了一个有用的工具。
Aim The aim of this study was to build and verify a preliminary physiologically based pharmacokinetic (PBPK) model of Chinese pregnant women. The model was used to predict maternal pharmacokinetics (PK) of 6 predominantly renally cleared drugs. Method Based on SimCYP Caucasian pregnancy population dataset, the preliminary Chinese pregnant population was built by updating several key parameters and equations according to physiological parameters of Chinese (or Japanese) pregnant women. Drug-specific parameters of 6 renally cleared drugs were validated through PBPK modeling of Caucasian non-pregnant, Caucasian pregnant and Chinese non-pregnant population. The preliminary PBPK model of Chinese pregnant population was then developed by integrating the preliminary Chinese pregnant population and the drug-specific parameters. This model was verified by comparing the predicted maternal PK of these 6 drugs with the observed in vivo data from the literature. Results The preliminary Chinese pregnant population PBPK model successfully predicted the PK of 6 target drugs for different pregnancy stages. The predicted plasma concentrations time profiles fitted the observed data well, and most predicted PK parameters were within 2-fold of observed data.Conclusions: The preliminary Chinese pregnant population PBPK model provided a useful tool to predict the maternal PK of 6 predominantly renally cleared drugs in Chinese pregnant women.
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DOI：
--
发表时间：
1988-11
期刊：
The Japanese journal of antibiotics
影响因子：
--
作者：
N. Cho;K. Fukunaga;K. Kunii;I. Kobayashi;K. Tezuka
通讯作者：
N. Cho;K. Fukunaga;K. Kunii;I. Kobayashi;K. Tezuka
DOI：
--
发表时间：
2009
期刊：
The Chinese Journal of Clinical Pharmacology
影响因子：
--
作者：
Zeng Ping
通讯作者：
Zeng Ping
DOI：
10.1002/j.1552-4604.1993.tb04690.x
发表时间：
1993-05
期刊：
The Journal of Clinical Pharmacology
影响因子：
--
作者：
B. Meyers;P. Wilkinson;M. Mendelson;C. Bournazos;Carmelita Tejero;S. Hirschman
通讯作者：
B. Meyers;P. Wilkinson;M. Mendelson;C. Bournazos;Carmelita Tejero;S. Hirschman
影响因子：
4.5
作者：
M. Lalic-Popovic;J. Paunković;Z. Grujić;S. Goločorbin-Kon;L. Milašinović;H. Al‐Salami;M. Mikov
通讯作者：
M. Lalic-Popovic;J. Paunković;Z. Grujić;S. Goločorbin-Kon;L. Milašinović;H. Al‐Salami;M. Mikov
影响因子：
4.5
作者：
Mendes, Mailys De Sousa;Lui, Gabrielle;Benaboud, Sihem
通讯作者：
Benaboud, Sihem