Drug Development Stewardship and Strategic Planning

Simcyp Workshops FAQ

Learn More About Our Simcyp Workshops What are the benefits of the Simcyp week-long workshops? Participants will learn about the application of “prior knowledge” to improve the selection and design of clinical studies. The workshops are designed to provide the necessary understanding and skills to simulate and predict the pharmacokinetics of drugs in any relevant […]

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Simcyp Workshops

About Our Workshops Learn About The Simcyp Workshops The model-based approach to various aspects of drug development is rapidly being adopted by many of the leading pharmaceutical companies and has been identified by the FDA as a valuable tool to improve efficiency in drug development. These workshops focus on the optimal use of compound-specific in […]

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Prediction of Drug-drug Interactions

Predicting Drug-drug Interactions Using the Simcyp Simulator Unmanageable drug-drug interactions have led to the withdrawal of numerous drugs from the market. Many of these interactions involve inhibition and, to a lesser extent, induction of drug metabolizing enzymes. Consequently, the ability to predict metabolically-based drug-drug interactions (mDDI) early in the drug development process is essential. The sophisticated […]

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Virtual Populations

Virtual Populations in the Simcyp Simulator The utility of in vitro-in vivo extrapolation has historically been limited by: Projections are usually only made to mean data collected in studies in healthy, young, Caucasian, male individuals. Other approaches provide inadequate estimates of intersubject variability based solely on simple demographic parameters. This limits their ability to address the […]

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Simcyp Pediatric

Model Pharmacokinetics in Virtual Children Simcyp® Pediatric is a module within the Simcyp Population-based Simulator, which is licensed to members of the Simcyp Consortium of leading pharmaceutical and biotechnology companies. It allows pharmacokinetic behavior to be modeled in neonates, infants and children. This provides valuable information relevant to first-time dosing decisions and the design of […]

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Cardiac Safety Simulator

Addressing Drug Candidates’ Cardiotoxicity Risk The Cardiac Safety SimulatorTM (CSS) is a software solution that integrates physiologically-based pharmacokinetic PBPK modeling and simulation with a cardiomyocyte model to predict the cardiac effects of drugs. It is a standalone product and can be purchased independently of Certara’s Simcyp® Simulator. Drug-induced cardiovascular adverse events are one of the […]

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Simcyp Simulator

The Standard for Population-based Pharmacokinetic Modeling and Simulation Used by all of the top 10 global pharmaceutical companies, together with the US Food and Drug Administration (FDA) and other key regulatory agencies, the Simcyp® Simulator is the industry’s most sophisticated solution for assisting in dose selection and informing product labeling. It links in vitro data […]

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Simcyp PBPK Modeling and Simulation

Simcyp.com has moved to Certara.com The Simcyp’s Population-based Simulator, combined with our suite of software products and scientific consulting services has provided significant drug development advantages to our clients. The Simcyp Simulator includes extensive demographic, physiologic and genomic databases which include algorithms which account for patient variability. This enables the user to predict drug behavior in virtual […]

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Simcyp PBPK Modeling and Simulation

Simcyp.com has moved to Certara.com The Simcyp’s Population-based Simulator, combined with our suite of software products and scientific consulting services has provided significant drug development advantages to our clients. The Simcyp Simulator includes extensive demographic, physiologic and genomic databases which include algorithms which account for patient variability. This enables the user to predict drug behavior in virtual […]

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