Chinese experts′consensus on protocol of breakpoints setting of new antibacterial agents for clinical trial
- VernacularTitle:新抗菌药物临床试验折点制定方案专家共识
- Author:
Yun LI
1
;
Bo ZHENG
;
Yuan LV
;
Min-Ji WEI
;
Ai-Lian SHAN
;
Zhao-Long CAO
;
Ruo-Yu LI
;
Qin-Ping LIAO
;
Ming-Gui LIN
;
Xiao-Ju LV
;
Xiao-Jun MA
;
Yun-Xing NI
;
Ming-Qing TONG
;
Rui WANG
;
Ying-Chun XU
;
Xue-Fu YOU
;
Jing ZHANG
;
Qiong ZHANG
;
Sui-Yang ZHANG
;
Ming ZHAO
;
Qing-Shan ZHENG
;
Chao ZHUO
Author Information
- Keywords: susceptibility breakpoint; antibacterial agents; minimal inhibitory concentration; pharmacokinetic; pharmacodynamic
- From: The Chinese Journal of Clinical Pharmacology 2015;(11):1069-1076
- CountryChina
- Language:Chinese
- Abstract: Clinical breakpoints are used in phaseⅡorⅢclinical trials to categorize microorganisms if susceptibility to new tested antibacterial agents that means the patient infected by the pathogen will be enrolled the study or not.The role of this consensus is to define procedure and required data to setting breakpoints and how to revaluate it in clinical trials.
