期刊論文
| 學年 | 108 |
|---|---|
| 學期 | 2 |
| 出版（發表）日期 | 2020-05-12 |
| 作品名稱 | Use of a tolerance interval approach as a statistical quality control tool for traditional Chinese medicine |
| 作品名稱（其他語言） | |
| 著者 | Chieh Chiang; Yi-Hsuan Lai; Bo-Han Huang; Wen-Jin Guo; Yuh-Jenn Wu; Lien-Cheng Chang; Chin-Fu Hsiao |
| 單位 | |
| 出版者 | |
| 著錄名稱、卷期、頁數 | Journal of biopharmaceutical statistics 30(5), p.873-881 |
| 摘要 | Raw materials for traditional Chinese medicine (TCM) are often from different resources and its final product may also be made by different sites. Therefore, variabilities from different resources such as site-to-site or within site component-to-component may be expected. Consequently, test for consistency in raw materials, in-process materials, and/or final product has become an important issue in the quality control (QC) process in TCM development. In this paper, a statistical QC process for raw materials and/or the final product of TCM is proposed based on a two sided β–content, γ–confidence tolerance interval. More specifically, we construct the tolerance interval for a random-effects model to assess the QC of TCM products from different regions and possibly different product batches. The products can be claimed to be consistency when the constructed tolerance interval is within the permitted range. Given the region and batch effects, sample sizes can also be calculated to ensure the desired measure of goodness. An example is presented to illustrate the proposed approach. |
| 關鍵字 | Consistency;random-effects model;tolerance interval |
| 語言 | zh_TW |
| ISSN | 1054-3406 |
| 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/987654321/122703 ) |