创新性抗菌药物人体耐受性试验的基本要求和关注问题的讨论

Discussion on basic requirement and concerned questions in human tolerance test of new anti-bacterial drugs

人体耐受性试验可为创新药物短期安全性的早期评价、早期探索性治疗试验的剂量、给药方案以及治疗持续时间的优化提供基本信息,这对于临床试验设计有重要价值。本文依据相关文献、ICH指导原则和我国《抗菌药物临床试验技术指导原则》的要求,探讨了创新性抗菌药物人体耐受性试验的基本考虑及其关注的问题,旨在促进创新性抗菌药物的研发和评价。

Human tolerance test of new anti - bacterial drugs can provide basic information for early evaluation of short - term safety, and optimization of dose, dose regimen as well as duration of initial exploratory - bacterial drugs of China （draft）,. Based on trial of anti this article discusses the key points should be considered in human tolerance test of new anti-bacterial agent, in order to promote antibacterial drug research and evelopment.