Use of a tolerance interval approach as a statistical quality control tool for traditional Chinese medicine
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 )