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Certara to Participate in 19 Sessions at ACoP7

PRINCETON, NJ – Oct. 21, 2016 – Certara today announced it will be participating in 19 sessions at the Seventh American Conference on Pharmacometrics (ACoP7). This year’s conference is being held from Oct. 23-26 in Bellevue, Washington.

Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug

Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety and efficacy. These factors include intrinsic variability― CYP metabolizer status, age, sex, renal/hepatic impairment― as well as external variables― co-medications, food effects, smoker status, etc. Clinical trials alone … Continued

米国FDAのジェネリック医薬品局、
モデリング&シミュレーションへの
助成金をCertaraのSimcyp部門に提供

PRINCETON, NJ – Oct. 19, 2016 – Certara announces that the Office of Generic Drugs (OGD), US Food and Drug Administration (FDA) has awarded it a multi-year research grant to create and validate a physiologically-based pharmacokinetic (PBPK) modeling and simulation framework that complements existing models within the Simcyp Population-based Simulator.

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