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Unified approaches to assessing treatment effect of traditional Chinese medicine based on health profiles.
Journal of Biopharmaceutical Statistics ( IF 1.1 ) Pub Date : 2020-02-17 , DOI: 10.1080/10543406.2020.1726368
Bin Cheng 1 , Bingzhi Zhang 2 , Shein-Chung Chow 3
Affiliation  

Two dissimilarity indices are introduced to measure the disharmony of a human body system by mimicking the population bioequivalence and the individual bioequivalence concepts. Hypotheses for the treatment effect of a traditional Chinese medicine are formulated based on the two indices and then tested under the proposed designs by reverting an approximate confidence upper bound. The proposed methods can also be used when a drug product has multiple components or a trial has multiple endpoints.

中文翻译:

基于健康状况评估中药治疗效果的统一方法。

通过模仿种群生物等效性和个体生物等效性概念,引入了两个相异性指标来衡量人体系统的不协调性。基于这两个指标制定了中药治疗效果的假设,然后在拟议的设计下通过还原近似置信度上限进行检验。当药品具有多种成分或试验具有多个终点时,也可以使用提出的方法。
更新日期:2020-02-17
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