淡江大學機構典藏:Item 987654321/122703
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    题名: Use of a tolerance interval approach as a statistical quality control tool for traditional Chinese medicine
    作者: Chiang, Chieh;Lai, Yi-Hsuan;Huang, Bo-Han;Guo, Wen-Jin;Wu, Yuh-Jenn;Chang, Lien-Cheng;Hsiao, Chin-Fu
    关键词: Consistency;random-effects model;tolerance interval
    日期: 2020-05-12
    上传时间: 2022-05-09 12:10:41 (UTC+8)
    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.
    關聯: Journal of biopharmaceutical statistics 30(5), p.873-881
    DOI: 10.1080/10543406.2020.1757693
    显示于类别:[數學學系暨研究所] 期刊論文

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