抗菌药物临床试验技术指导原则起草背景及有关情况说明

Explanation on drafting background of guidance for clinical studies of antibacterial drugs

本文主要阐述了抗菌药物临床试验技术指导原则重新撰写的原因、撰写程序、撰写中参考的文献资料及撰写中所关注的有关问题。

This article is to describe the causes, procedures, references, and some important consideration in drafting out new guidance for clinical trials of anti -bacterial drugs.