教師資料查詢 | 類別: 期刊論文 | 教師: 姜 杰CHIANG, CHIEH (瀏覽個人網頁)

標題:Use of a two‐sided tolerance interval in the design and evaluation of biosimilarity in clinical studies
學年109
學期1
出版(發表)日期2020/09/01
作品名稱Use of a two‐sided tolerance interval in the design and evaluation of biosimilarity in clinical studies
作品名稱(其他語言)
著者Chieh Chiang; Chi-Tian Chen; Chin-Fu Hsiao
單位
出版者
著錄名稱、卷期、頁數Pharmaceutical Statistics 20(1), p.175-184
摘要In assessing biosimilarity between two products, the question to ask is always “How similar is similar?” Traditionally, the equivalence of the means between products is the primary consideration in a clinical trial. This study suggests an alternative assessment for testing a certain percentage of the population of differences lying within a prespecified interval. In doing so, the accuracy and precision are assessed simultaneously by judging whether a two-sided tolerance interval falls within a prespecified acceptance range. We further derive an asymptotic distribution of the tolerance limits to determine the sample size for achieving a targeted level of power. Our numerical study shows that the proposed two-sided tolerance interval test controls the type I error rate and provides sufficient power. A real example is presented to illustrate our proposed approach.
關鍵字
語言中文
ISSN1539-1604
期刊性質國外
收錄於SCI;
產學合作
通訊作者
審稿制度
國別美國
公開徵稿
出版型式,電子版
相關連結
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