【課程介紹】
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.
【講師簡介】
莊易博士 (Yi Tsong, Ph.D.)
美國食品及藥物管理局的藥物評量與研究中心 (CDER, FDA)
【主題、時間、地點】
Equivalence Tests: An Overview
103年11月13日(四)10:30-12:00
醫學綜合大樓(前棟)三樓 祕書處旁的會議室
【對象】
全校教職員及三院同仁
【承辦單位】
生物統計研究中心
【聯絡窗口】
吳小姐(#2735-7873)
