Statistical Methods for Bridging Studies
學年 101
學期 1
出版(發表)日期 2012-09-04
作品名稱 Statistical Methods for Bridging Studies
著者 Shein-Chung Chow; Chieh Chiang; Jen-pei Liu; Chin-Fu Hsiao
著錄名稱、卷期、頁數 Journal of biopharmaceutical statistics 22(5), p.903-915
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.
關鍵字 Complete clinical data package (CCDP);Consistency;Ethnic factor;Generalizability;Similarity
語言 en_US
ISSN 1054-3406
期刊性質 國外
收錄於 SCI
國別 USA
出版型式 ,電子版

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