【课程介绍】
The objective of an equivalence study is to demonstrate if the two drug products are equivalent. However, “equivalence” may be defined in various ways. It may mean that the two drugs lead to similar responses; or to similar efficacies (over placebo) within a defined margin of equivalence. Depending on which of the two objectives, margin determination, study design, measurement and test may be different. In this presentation, the speaker will give an overview of the equivalence test.
【讲师简介】
庄易博士 (Yi Tsong, Ph.D.)
美国食品及药物管理局的药物評量與研究中心 (CDER, FDA)
【主题、时间、地点】
Equivalence Tests: An Overview
103年11月13日(四)10:30-12:00
医學综合大楼(前栋)三楼 祕書处旁的会议室
【对象】
全校教职员及三院同仁
【承办单位】
生物统计研究中心
【联絡窗口】 吴小姐(#2735-7873)
