日本抗菌药物临床评价指导原则介绍

Introduction of guidance for clinical evaluation of antibacterial drug in Japan

抗菌药物是一类具有独特治疗学特点的药物,其临床评价存在诸多不同于一般药物评价的考虑,本文通过介绍日本"抗菌药物临床评价指导原则",以期为相关药物研发和评价人员提供参考。

Antibacterial drug is a drug with special therapeutics characteristics. The clinical evaluation points of this kind of drug different from the other drugs. Therefore, this article introduce the ＂guidance for clinical evaluation of antibacterial drug＂ in Japan in order to offer more information for the investigator and appraiser.