^○Akihiro Hisaka (Clinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba University)

^○Yuki Matsumoto ^1,2, Takafumi Iwatsubo ², Satoki Imai ², Kaoru Kobayashi ², Hiroshi Kodaira ², Shingo Sakamoto ², Masakazu Shibata ², Yoshikazu Kurahashi ², Shin-ichi Miura ², Kazuto Watanabe ² (1.Clinical Pharmacokinetics & Pharmacometrics Group, Clinical Pharmacology Development, Japan Development, MSD K.K., 2.Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufactures Association)

^○Masato Ohbuchi (Analysis & Pharmacokinetics Research Laboratories, Pharmacokinetis-Pharmacodynamics, Astellas Pharma Inc.)

^○Shin-ichi Inoue (Drug Metabolism ＆ Pharmacokinetics Research Laboratories, Daiichi Sankyo Co.,Ltd.)

^○Reiko Sato (Pharmaceuticals and Medical Devices Agency)

^○Naomi Nagai (Pharmaceuticals and Medical Devices Agency)