中国临床药理学杂志2024，Vol.40Issue(16)：2452-2456,5.DOI:10.13699/j.cnki.1001-6821.2024.16.032
模型引导抗菌药物剂量优化的相关考虑
Considerations for model-informed dose optimization of antimicrobial drugs
刘美霞 1贺锐锐 1刘冬 1王骏1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100022
- 折叠
摘要
Abstract
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.关键词
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Key words
antimicrobial drugs/dose optimization/pharmacokinetic/pharmacodynamic studies/special populations/population pharmacokinetics分类
药学引用本文复制引用
刘美霞,贺锐锐,刘冬,王骏..模型引导抗菌药物剂量优化的相关考虑[J].中国临床药理学杂志,2024,40(16):2452-2456,5.
