美国FDA对抗菌药物临床试验方案的考虑及其借鉴

FDA's general considerations on the antibacterial dugs clinical trial protocol issues and its enlightenment

本文通过介绍美国食品药品监督管理局对抗菌药物临床试验方案和其原理的一般考虑,与大家共同探讨抗菌药物临床试验方案的合理设计。

This article is to introduce FDA＇ s （ Food and Drug Administration, FDA） general considerations on the protocol issues and elements used in anti -bacterial drug clinical trials, and to discusse the appropriate trial design of these drugs.