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模型引导抗菌药物剂量优化的相关考虑

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模型引导的抗菌药物剂量优化在抗菌药物的研发及上市后变更给药方案中具有重要价值.国内抗菌药物在应用模型方法支持剂量优化时,经常出现缺乏充足可靠数据、缺乏对特殊人群给药方案探索等问题.本文根据作者实际工作经验,结合模型引导剂量优化在抗菌药物应用中的具体案例,对模型引导剂量优化在创新抗菌药物研发、特殊人群给药方案选择及上市后给药方案变更中的相关问题进行讨论,以期为国内抗菌药物研发及上市后给药方案的选择提供参考.
Considerations for model-informed dose optimization of antimicrobial drugs
Model-informed dose optimization of antimicrobial drugs is of great value in the development of antimicrobial drugs and post-marketing dosing regimens.There are often problems such as lack of sufficient and reliable data and lack of exploration of dosing regimens for special populations,during domestic antimicrobial drugs applied model methods to support dose optimization.Based on the author's practical work experience and the typical cases of model-informed dose optimization in the application of antimicrobial drugs,this article discusses the relevant issues of model-informed dose optimization in the research and development of innovative antimicrobial drugs,the selection of dosing regimens for special populations and the change of post-marketing dosing regimens,in order to provide references for the development of domestic antimicrobial drugs and the selection of post-marketing dosing regimens.

antimicrobial drugsdose optimizationpharmacokinetic/pharmacodynamic studiesspecial populationspopulation pharmacokinetics

刘美霞、贺锐锐、刘冬、王骏

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国家药品监督管理局药品审评中心,北京 100022

抗菌药物 剂量优化 药代动力学/药效学研究 特殊人群 群体药代动力学

2024

中国临床药理学杂志
中国药学会

中国临床药理学杂志

CSTPCD北大核心
影响因子:1.91
ISSN:1001-6821
年,卷(期):2024.40(16)