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 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
語言中文
ISSN1054-3406
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
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