期刊論文
| 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 ) |