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FDA Renews and Expands its Portfolio of Simcyp Simulator (PBPK) Licenses

PRINCETON, NJ – Nov. 14, 2017 – Certara today announced that the US Food and Drug Administration has greatly expanded its use of Certara’s PBPK Simcyp Population-based Simulator and its Pediatric and Cardiac Safety Simulators. Under the new agreement, FDA has almost tripled its number of licenses, equipping its M&S review team with almost 60 PBPK licenses.

Solution: PBPK Modeling & Simulation
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Kyowa Hakko Kirin Joins Certara’s Simcyp Consortium

PRINCETON, NJ – Sept. 13, 2017 – Certara today announced that Kyowa Hakko Kirin Co., Ltd. has joined the Simcyp Consortium and licensed the Simcyp Population-based Simulator. Kyowa Hakko Kirin is the 36th leading biopharmaceutical company and the 11th Japanese pharmaceutical company to join the Consortium.

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