• J Biopharm Stat · Jan 2015

    A Dose-Finding Method Based on Multiple Dosing in Two-Agent Combination Phase I Trials.

    • Yasuyuki Kakurai, Akihiro Hirakawa, and Chikuma Hamada.
    • a Department of Management Science, Graduate School of Engineering , Tokyo University of Science , Tokyo , Japan.
    • J Biopharm Stat. 2015 Jan 1; 25 (5): 1065-76.

    AbstractHere, we developed a new dose-finding method that partitions a cohort of patients based on the number of dose combinations within a prespecified acceptable toxicity range in two-agent combination Phase I trials. In the proposed method, patients in the same cohort are partitioned according to several dose combinations, although most of the existing methods allocate patients in the same cohort according to a single-dose combination. We compared the operating characteristics of the proposed and existing methods through simulation studies.

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