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Optimization of oral isavuconazole dose for population in special physiological or pathological state: a physiologically based pharmacokinetics model-informed precision dosing

文献类型：期刊论文

作者Zhou, Jianxing2,3; Xu, Baohua2,3; Zheng, You2,3; Huang, Huiping2,3; Wei, Zipeng2,3; Chen, Shengyang2,3; Huang, Wei2,3; Liu, Maobai2,3; Zhang, Yifan1; Wu, Xuemei2,3
刊名JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
出版日期2024-08-01
页码11
ISSN号0305-7453
DOI10.1093/jac/dkae240
通讯作者Wu, Xuemei(wuxuemei@fjmu.edu.cn)
英文摘要Objective To recommend precision dosing and improve therapeutic efficacy against invasive fungal disease, a physiologically based pharmacokinetic model (PBPK) of oral isavuconazole (ISA) was established and used to explore its disposition across populations in different physiological and pathological states.Methods Twenty-five pharmacokinetic (PK) studies of oral ISA were identified through a systematic search of PubMed. Concentration-time data were extracted using WebPlotDigitizer. Physiochemical parameters were obtained from published literature and DrugBank. Model development and simulation used the Simcyp population-based simulator, and visual predictive check and predictive error were used for the model evaluation. Probability of target attainment and the cumulative fraction of response analyses were performed for dose optimization.Results The developed PBPK model was successfully validated in different populations. Most predicted concentration-time points aligned with the observed data, with acceptable predictive errors for the critical parameters. We predicted the PK profiles and parameters of ISA in a population with severe hepatic impairment (HI), a population with obesity and paediatric patients aged 1 to less than 6 years old. The probability of target attainment and cumulative fraction of response analyses indicated that the population with severe HI should have half the maintenance dose. The population with obesity and population with severe HI should have a loading dose of 300 mg every 8 h for 2 days. For paediatric patients aged 1 to less than 6 years old, a weight-based dosing regimen (5.38 mg/kg) of ISA was suggested.Conclusion The predicted value aligns with observations, suggesting ISA's potential predictability in PK profiles for other populations. The recommended dosing regimens increase our understanding of the use of ISA in special populations.
WOS关键词ANTIFUNGAL TRIAZOLE BAL4815 ; BAL8557 ; PRODRUG ; SAFETY ; DRUGS
资助项目Fujian provincial health technology project[2020CXB014]
WOS研究方向Infectious Diseases ; Microbiology ; Pharmacology & Pharmacy
语种英语
WOS记录号WOS:001283248800001
出版者OXFORD UNIV PRESS
源URL[http://119.78.100.183/handle/2S10ELR8/312577]  
专题中国科学院上海药物研究所
通讯作者Wu, Xuemei
作者单位1.Chinese Acad Sci, Shanghai Inst Mat Med, Shanghai, Peoples R China
2.Fujian Med Univ, Union Hosp, Dept Pharm, Fuzhou, Fujian, Peoples R China
3.Fujian Med Univ, Sch Pharm, Fuzhou, Fujian, Peoples R China
推荐引用方式
GB/T 7714		 Zhou, Jianxing,Xu, Baohua,Zheng, You,et al. Optimization of oral isavuconazole dose for population in special physiological or pathological state: a physiologically based pharmacokinetics model-informed precision dosing[J]. JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY,2024:11.
APA Zhou, Jianxing.,Xu, Baohua.,Zheng, You.,Huang, Huiping.,Wei, Zipeng.,...&Wu, Xuemei.(2024).Optimization of oral isavuconazole dose for population in special physiological or pathological state: a physiologically based pharmacokinetics model-informed precision dosing.JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY,11.
MLA Zhou, Jianxing,et al."Optimization of oral isavuconazole dose for population in special physiological or pathological state: a physiologically based pharmacokinetics model-informed precision dosing".JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY (2024):11.

入库方式： OAI收割

来源：上海药物研究所

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