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 zh_TW
ISSN 1539-1604
期刊性質 國外
收錄於 SCI
產學合作
通訊作者
審稿制度 否
國別 USA
公開徵稿
出版型式 ,電子版
相關連結

機構典藏連結 ( http://tkuir.lib.tku.edu.tw:8080/dspace/handle/987654321/122704 )