新抗菌药物临床试验折点制定方案专家共识
신항균약물림상시험절점제정방안전가공식
Chinese experts′consensus on protocol of breakpoints setting of new antibacterial agents for clinical trial
  • 万方数据
    中国临床药理学杂志 중국림상약이학잡지
    THE CHINESE JOURNAL OF CLINICAL PHARMACOLOGY
    2015年 11期 1069-1076 ,共8页

    李耘%郑波%吕媛%魏敏吉%单爱莲%曹照龙%李若瑜%廖秦平%林明贵%吕晓菊%马小军%倪语星%童明庆%王睿%徐英春%游学甫%张菁%张琼%张睢阳%赵明%郑青山%卓超

    리운%정파%려원%위민길%단애련%조조룡%리약유%료진평%림명귀%려효국%마소군%예어성%동명경%왕예%서영춘%유학보%장정%장경%장휴양%조명%정청산%탁초

    敏感折点%抗菌药物%最低抑菌浓度%药代动力学%药效学 敏感摺點%抗菌藥物%最低抑菌濃度%藥代動力學%藥效學
    민감절점%항균약물%최저억균농도%약대동역학%약효학
    susceptibility breakpoint%antibacterial agents%minimal inhibitory concentration%pharmacokinetic%pharmacodynamic
    首次进入有效性评价临床试验的新抗菌药物，需根据其体外抗菌活性、药代动力学特性等，提出临床试验用敏感折点，以便临床试验时筛选对该药物敏感致病菌感染患者入组，同时对此折点合理性进行再评价。
    수차진입유효성평개림상시험적신항균약물，수근거기체외항균활성、약대동역학특성등，제출림상시험용민감절점，이편림상시험시사선대해약물민감치병균감염환자입조，동시대차절점합이성진행재평개。
    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.
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