I-Chun Lai, Chin-Fu Hsiao, Lih-jiuan Hsu, and Churn-Shiouh Gau

Recently, global drug developments have attracted considerable attention from sponsors and regulatory authorities. Key issues are when and how to address geographic variations in efficacy and safety for drug development. Such variations depend on the size of the market of each geographic region, development costs, and factors influencing clinical outcomes for evaluating efficacy and safety.

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