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[摘要]
美国食品药品管理局(FDA)于2016年8月发布了“全身用抗菌药的微生物学数据——产生、分析和描述的供企业用指导原则”,详细介绍了FDA对抗菌药微生物学研究全过程的要求。该指导原则对我国抗菌药微生物学研究和监管都有重要的参考价值,以下内容尤其值得关注:对体外抗菌药敏感性试验(AST)方法、质量控制(QC)参数和AST解释标准的要求,对说明书微生物学项目格式和内容的要求,对抗菌药上市后定期评价和更新说明书体外AST方法、QC参数和AST解释标准的要求,对体外敏感性试验分离菌株数量和致病菌特点的要求。
[Key word]
[Abstract]
FDA in August 2016 released "Microbiology Data for Systemic Antibacterial Drugs-Development, Analysis, and Presentation Guidance for Industry", which introduced requirements of the whole process of the research on the microbiology of systemic antimicrobial drugs by FDA. Therefore, the guidance of FDA has an important reference value for the research and supervision of the systemic antimicrobial drugs in our country. The following are particularly noteworthy:requirements for the in vitro AST methods, the QC parameters and the AST interpretive criteria; Requirements for the format and content of the labeling microbiology portion; requirements for periodic evaluation and update of the in vitro AST methods, the QC parameters, and the AST interpretive criteria in postmarketing labeling; Requirements for the number of isolates and the characteristics of pathogenic bacteria for in vitro sensitivity test.
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