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Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator models describe the behavior of drugs in different body tissues and includes genetic, physiological and epidemiological databases that facilitate simulations in virtual populations. The Simcyp Simulator has been used to inform more than 250 label claims for 85+ novel drug approvals by the US Food and Drug Administration (FDA). These were achieved virtually, using PBPK modeling and simulation in lieu of performing clinical trials.

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Simcyp PBPK Simulatorは、医薬品開発におけるPBPKモデリングの業界標準として最も広く活用されているプラットフォームです。Developed through the expertise of a 25 year-long consortium involving 37 leading global pharmaceutical companies, the Simcyp PBPK Simulator is recognized and licensed by 11 regulatory agencies worldwide.

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