抗菌药物折点研究技术指导原则(国家药品监督管理局通告2018年第31号) ... ... ...

2023-6-6 17:49| 发布者: 杏林| 查看: 865| 评论: 0|来自: 国家药监局

摘要: 本则为药品注册申请人和临床试验研究者在规划、设计、实施和监督抗菌药物敏感折点研究和敏感标准制定提供必要的技术指导,主要用于指导创新抗菌药物折点研究,目前仅限定为抗细菌药物,对于一些针对特殊病原体的药物 ...


十一、参考文献

1. Turnidge J and Paterson DL. Setting and revising antibacterial susceptibility breakpoints [J]. Clinical Microbiology Reviews, 2007, 20: 391-408.

2. Turnidge J, Kahlmeter G and Kronvall G. Statistical characterization of bacterial wild-type MIC value distributions and the determination of epidemiological cut-off value [J]. Clinical Microbiology and Infection, 2006, 12: 418-425.

3. Owens RC and Shorr AF. Rational dosing of antimicrobial agents: pharmacokinetic and pharmacodynamics strategies [J]. Am J Health-Syst Pharm, 2009, 66Suppl 4: S23-30.

4. Ambrose PG, Bhavnani SM, Rubino CM, et al. Pharmacokinetics- pharmacodynamics of antimicrobial therapy: it’s not just for mice anymore [J]. Clin Infec Dis, 2007, 44: 79-86.

5. Amsterdam D, edited. Antibiotics in Laboratory Medicine [M]. Wolters Kluwer, Philadelphia, 6th edition, 2015, p9-16.

6. Xiao XM, Xiao YH. Pharmacokinetics/pharmacodynamics of antofloxacin hydrochloride in a neutropenic murine thigh model of Staphylococcus aureus infection[J]. Acta Pharmacol Sin, 2008, 29:1253-1260.

7. 史军. 药物动力学和药效动力学在抗菌药物新药开发和临床治疗上的应用. 中国临床药理学与治疗学, 2007, 12:121-133.

8. Clinical and Laboratory Standards Institute. 2008 Development of in vitro susceptibility testing criteria and quality control parameters: approved guideline-3rd ed. [M]. CLSI document M23-A3 CLSI, Wayne, PA.

 

附:工作流程及建立PK/PD界值流程

 

工作流程及建立PK/PD界值流程

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