Statistical Analysis for Multi-National Clinical Trials on Inter-variations among Regions
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    *Masahiro Takeuchi, Kitasato University 


Statistical Analyses have been investigated on multi-national clinical trials. Currently, the ICH E5 guideline discusses in details inter, and intra variabilities among regions to consider possibility of extrapolation of data to new regions. We will propose and introduce statistical approaches focusing on inter and intra variabilities.