• J Biopharm Stat · Sep 2012

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    Decision rules and associated sample size planning for regional approval utilizing multiregional clinical trials.

    • Xiaoyuan Chen, Nelson Lu, Rajesh Nair, Yunling Xu, Cailian Kang, Qin Huang, Ning Li, and Hongzhuan Chen.
    • Department of Pharmacology and Biostatistics, Shanghai JiaoTong University School of Medicine, Shanghai, China.
    • J Biopharm Stat. 2012 Sep 1; 22 (5): 1001-18.

    AbstractMultiregional clinical trials provide the potential to make safe and effective medical products simultaneously available to patients globally. As regulatory decisions are always made in a local context, this poses huge regulatory challenges. In this article we propose two conditional decision rules that can be used for medical product approval by local regulatory agencies based on the results of a multiregional clinical trial. We also illustrate sample size planning for such trials.

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