Masaaki Doi

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The efficiency and safety of a new treatment is occasionally evaluated using Poisson distributed count data as the criteria in clinical studies. In such scenarios, non-inferiority tests using Poisson distributed count data are often employed and evaluated in frequentist frameworks. However, in our previous work, we proposed and presented an index that(More)
Noninferiority trials have recently gained importance for the clinical trials of drugs and medical devices. In these trials, most statistical methods have been used from a frequentist perspective, and historical data have been used only for the specification of the noninferiority margin Δ>0. In contrast, Bayesian methods, which have been studied recently(More)
The purpose of the present study was to evaluate the pharmacokinetics of beraprost sodium (BPS) and its active enantiomer, BPS-314d, in Japanese subjects with impaired kidney function. The plasma and urine concentrations of BPS and BPS-314d were measured following the single oral administration of 120 μg of BPS as the sustained-release tablet, TRK-100STP,(More)
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