國家衛生研究院 NHRI:Item 3990099045/12691
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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, C;Lai, YH;Huang, BH;Guo, WJ;Wu, YJ;Chang, LC;Hsiao, CF
    贡献者: Institute of Population Health Sciences
    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 [Formula: see text]-content, [Formula: see text]-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.
    日期: 2020-09-02
    關聯: Journal of Biopharmaceutical Statistics. 2020 Spe 2;30(5):873-881.
    Link to: http://dx.doi.org/10.1080/10543406.2020.1757693
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1054-3406&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000534277200001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85085041587
    显示于类别:[蕭金福] 期刊論文

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