FDA对全身用抗菌药微生物学研究的要求

FDA's requirement on microbiological research of systemic antibacterial drug

美国食品药品管理局(FDA)的"全身用抗菌药品微生物资料的获得、分析和介绍"指导原则(草案),反映了FDA当前对全身用抗菌药微生物学研究的要求,而我国至今尚无类似的指导原则。本文简要介绍FDA该指导原则的主要内容,以期对我国全身用抗菌药研发和评价有帮助。

FDA′s ＂Guidance for Industry Microbiological Data for Systemic Antibacterial Drug Products-Development,Analysis,and Presentation＂（draft）,has reflected it′s current requirement on microbiological research of systemic antibacterial drug,but there have the similar guidance in our country until now.This article briefly introduced the main contents of the FDA′s guidance.It is hoped to help our country′s development and evaluation of systemic antibacterial drug in our country.