Domestic Data Foreign Data PMS Pivotal dose-response IIa PK / PD Personal Perspective on Bridging Domestic Data Foreign Data PMS Pivotal dose-response IIa PK / PD

“Bridge” is one of many bridges in the development of a new drug “Bridge” is one of many bridges in the development of a new drug. It is not bigger, but rather smaller. Non-Clinical Clinical I IIa IIb III

PK parameter Clinical endpoint Dose PD parameter

Analysis of Dissimilarity Dose PK parameter Clinical endpoint PD parameter  Clinical endpoint  Clinical endpoint  PD  PK = . .  Dose  PD  PK  Dose

Bridging in Baseball Batting Average Japan U.S. Ichiro Ichiro Shinjo 0.400 Ichiro 0.380 0.360 Ichiro 0.340 0.320 Japan U.S. 0.300 0.280 Shinjo Shinjo 0.260 0.240 0.220 0.200