Considerations for model-informed dose optimization of antimicrobial drugs
10.13699/j.cnki.1001-6821.2024.16.032
- VernacularTitle:模型引导抗菌药物剂量优化的相关考虑
- Author:
Mei-Xia LIU
1
;
Rui-Rui HE
;
Dong LIU
;
Jun WANG
Author Information
1. 国家药品监督管理局药品审评中心,北京 100022
- Keywords:
antimicrobial drugs;
dose optimization;
pharmacokinetic/pharmacodynamic studies;
special populations;
population pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(16):2452-2456
- CountryChina
- Language:Chinese
-
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.
