Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA; Department of Medical Microbiology and Immunology, University of Wisconsin, Madison, WI, USA.
Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Curr Opin Pharmacol. 2017 Oct;36:94-99. doi: 10.1016/j.coph.2017.09.004. Epub 2017 Sep 29.
Animal infection models serve a critical role in the pre-clinical development of antimicrobials. Thoughtful use of these tools can be useful to design and de-risk subsequent clinical trials. Specifically, pharmacokinetic/pharmacodynamic (PK/PD) evaluation of antimicrobials can define the PK/PD driver and target magnitude. In doing so they provide guidance for dosing regimen design and forecast the likelihood of success against target pathogens at the infection site of interest. This review outlines the key design features to consider for successful assessment of experimental output.
动物感染模型在抗菌药物的临床前开发中起着至关重要的作用。明智地使用这些工具可以帮助设计和降低随后临床试验的风险。具体来说,抗菌药物的药代动力学/药效学(PK/PD)评估可以确定 PK/PD 驱动因素和目标幅度。这样可以为剂量方案设计提供指导,并预测在感兴趣的感染部位针对目标病原体的成功可能性。本文综述了成功评估实验结果所需考虑的关键设计特征。