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Perspective on Bridging Domestic and Foreign Data in Drug Development

Explore the pivotal dose-response "bridge" between domestic and foreign data in drug development phases from non-clinical to clinical trials. Analysis of dissimilarities in PK/PD parameters and dose endpoints is crucial.

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Perspective on Bridging Domestic and Foreign Data in Drug Development

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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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