淡江大學機構典藏:Item 987654321/122695
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    题名: Statistical Methods for Bridging Studies
    作者: Chow, Shein-Chung;Chiang, Chieh;Liu, Jen-pei;Hsiao, Chin-Fu
    关键词: Complete clinical data package (CCDP);Consistency;Ethnic factor;Generalizability;Similarity
    日期: 2012-09-04
    上传时间: 2022-05-09 12:10:27 (UTC+8)
    摘要: In 1998, the International Conference on Harmonization (ICH) published a guidance to facilitate the registration of medicines among ICH regions including the European Union, the United States, and Japan by recommending a framework for evaluating the impact of ethnic factors on a medicine's effect, such as its efficacy and safety at a particular dosage and dose regimen (ICH E5, 1998). The purpose of ICH E5 is not only to evaluate the ethnic factor influence on safety, efficacy, dosage, and dose regimen, but also more importantly to minimize duplication of clinical data and allow extrapolation of foreign clinical data to a new region. In this article, statistical methods for evaluation of bridging studies based on the concepts of consistency (Shih, 2001), reproducibility/generalizability (Shao and Chow, 2002), the weighted Z-tests for the design of bridging studies (Lan et al., 2005), and similarity between the new and original region based in terms of positive treatment effect (Hsiao et al., 2007) are studied. The relative merits and disadvantages of these methods are compared by several examples.
    關聯: Journal of biopharmaceutical statistics 22(5), p.903-915
    DOI: 10.1080/10543406.2012.701578
    显示于类别:[數學學系暨研究所] 期刊論文

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