[关键词]
[摘要]
美国食品药品监督管理局(FDA)于2020年6月发布了“供企业用社区获得性细菌性肺炎:治疗药物开发指导原则”。该指导原则阐述了FDA目前对支持治疗社区获得性细菌性肺炎适应症药物的总体开发方案和临床试验设计的看法。详细介绍该指导原则,期望对中国“社区获得性细菌性肺炎抗菌药物研发临床试验技术指导原则(征求意见稿)”的修订以及这类药物的临床研究和监管有帮助。
[Key word]
[Abstract]
FDA released Community-Acquired Bacterial Pneumonia:Developing Drugs for Treatment Guidance for Industry June 2020. This guidance described the FDA's current thinking about the overall development program and clinical trial designs for drugs to support an indication for the treatment of CABP. The guidance is described in detail. It is expected to be helpful to the revision of Technical guidelines for clinical trials of antimicrobial agents for community-acquired bacterial pneumonia (Draft), as well as the clinical trial and supervision of such drugs in China.
[中图分类号]
R951
[基金项目]