[关键词]
[摘要]
美国食品药品管理局(FDA)于2016年12月发布了“供企业用支持证明与参照药有生物相似性的临床药理学数据指导原则”,说明了对生物类似药临床药理学研究的试验设计和试验方法的要求,特别指出研究中应特别注意的问题。而我国尚无类似的指导原则,介绍FDA该指导原则,希望对我国这方面的研究和监管有益。
[Key word]
[Abstract]
FDA released "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product Guidance for Industry" in December, 2016. The guidance describes the requirements of the trial designs and trial methods for the biosimilar clinical pharmacological studies, and especially points out the problems that should be paid special attention to in the studies. However there is no similar guidance in China. This paper introduces the guidance of FDA, which is beneficial to the research and regulation in China.
[中图分类号]
[基金项目]