國家衛生研究院 NHRI:Item 3990099045/1747
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    題名: Statistical quality control process for traditional Chinese medicine
    作者: Tse, SK;Chang, JY;Su, WL;Chow, SC;Hsiung, C;Lu, QS
    貢獻者: Division of Biostatistics and Bioinformatics;National Institute of Cancer Research
    摘要: The statistical quality control process on raw materials and/or the final product of traditional Chinese medicine (TCM) is examined. We develop a statistical quality control (QC) method to assess a proposed consistency index of raw materials from different sources and/or final products manufactured at different sites. The idea is to construct a 95% confidence interval for a proposed consistency index under a sampling plan. If the constructed 95% confidence lower limit is greater than a prespecified QC lower limit, then we claim that the raw material or final products have passed the QC and hence can be released for further processing or use; otherwise, the raw materials and/or final product should be rejected. For a given component (the most active component if possible), a sampling plan is derived to ensure that there is a desired probability for establishing consistency between sites when there is truly no difference in raw materials or final products between sites. An example concerning the development of a TCM is presented to illustrate the proposed statistical QC method for assessing consistency in raw materials from two sites.
    關鍵詞: Pharmacology & Pharmacy;Statistics & Probability
    日期: 2006-12
    關聯: Journal of Biopharmaceutical Statistics. 2006 Dec;16(6):861-874.
    Link to: http://dx.doi.org/10.1080/10543400600808047
    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:000242044000009
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=33750882700
    顯示於類別:[熊昭] 期刊論文
    [張俊彥] 期刊論文

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