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Domestic Data Foreign Data PMS Pivotal dose-response IIa PK / PD

Published byOndřej Svoboda Modified over 5 years ago

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Presentation on theme: "Domestic Data Foreign Data PMS Pivotal dose-response IIa PK / PD"— Presentation transcript:

1 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

2 “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

3 PK parameter Clinical endpoint Dose PD parameter

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

5 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

6

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