从美国植物药批准案例看数据管理和生物统计分析

Consideration about Data Management and Biostatistics Analysis from A FDA's Botanical Drug Approval Case

2006年10月31日美国FDA批准了首个非单一组分的植物药Veregen。该药在美的成功上市,引起世界上其他传统植物药国家的广泛关注。通过该案例的深入分析,笔者从数据管理和统计角度思考国外植物药的研发理念和评价方法,希望对促进我国新药研发有一定参考。

FDA approved the first botanical drug of non-simplex ingredient on 31^st Oct 2006. The new drug＇s trade name is Veregen 15% Ointment. Veregen succeeded in coming into the market in U. S, which attracts other countries and regions＇ attention where traditional herbs have been always used. From the viewpoints of data management and biostatistics method, the authors will think and discuss this case well, and hope to pro- mote domestic new drug investigation.