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Domestic Data

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. It is not bigger, but rather smaller. Non-Clinical. Clinical. 0. I. IIa. IIb. III. PK parameter.

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Domestic Data

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

  2. “Bridge” is one of many bridges in the development of a new drug.It is not bigger, but rather smaller. Non-Clinical Clinical 0 I IIa IIb III

  3. PK parameter Clinical endpoint PD parameter Dose

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

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

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