政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/18175

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政大機構典藏 > 商學院 > 統計學系 > 期刊論文 > Item 140.119/18175

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题名:	Bayesian Approach to Evaluation of Bridging Studies
作者:	薛慧敏 Liu, Jen-pei;Hsiao, Chin-Fu;Hsueh, Hueymiin
日期:	2002-08
上传时间:	2008-12-19 14:52:59 (UTC+8)
摘要:	We address the issue of analysis of clinical data generated by the bridging study conducted in the new region to evaluate the similarity for extrapolation of the foreign clinical data. A bridging study is usually conducted in the new region only after the test product is approved for commercial marketing in the original region due to its proven efficacy and safety. Sufficient information on efficacy, safety, dosage, and dose regimen has already generated in the original region. The empirical Bayesian approach is proposed to synthesize the data generated by the bridging study and foreign clinical data generated in the original region for assessment of similarity between the new and the original regions. A method for sample size determination for the bridging study is also suggested. It can be shown that the total sample size is inversely proportional to the strength of the evidence for the efficacy presented in the original region and the proportion of the patients assigned to receive the test product in the bridging study.
關聯:	Journal of Biopharmaceutical Statistics, 12(3),401-408
数据类型:	article
DOI 連結:	http://dx.doi.org/10.1081/BIP-120014568
DOI:	10.1081/BIP-120014568
显示于类别:	[統計學系] 期刊論文

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