Simcyp Workshops FAQ

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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Prediction of Clearance

Predicting Drug Clearance Using the Simcyp Simulator The Simcyp® Simulator predicts in vivo drug clearance from in vitro data, for the average individual and across populations. It also measures variability in clearance as a function of: Proportional metabolism by each enzyme Genetic/environmental variations in enzyme abundance Ethnic differences in genotype frequencies and levels of CYP and UGT […]

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Drug Metabolism

Assessing Drug Metabolism Using the Simcyp Simulator The Simcyp® Simulator extrapolates in vivo metabolic clearance from routine in vitro data generated during drug development using a variety of systems, including human liver microsomes (HLM), human intestinal microsomes (HIM), human hepatocytes (HHEP), recombinant cytochrome P450 and UGT enzymes (rCYP, rUGT), and cytosolic or S9 tissue fractions. […]

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Distribution

Predicting Drug Distribution Characteristics Using the Simcyp Simulator The Simcyp® Simulator allows the prediction of drug distribution characteristics at several levels, including Prediction of Vss from drug lipophilicity and plasma protein binding data Prediction of drug concentration-time profiles in blood and tissues based on a full physiologically-based pharmacokinetic (PBPK) model The Simcyp Simulator estimates the variability in […]

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Absorption

Simulating Drug Absorption Using the Simcyp Simulator The Simcyp® Simulator’s models allows simulation of absorption through oral, dermal, and pulmonary routes. Oral absorption Oral delivery is the preferred route of administration for most drugs. Therefore, in the preclinical phase of development, a key consideration for many new chemical entities is their rate and extent of intestinal […]

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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 Animal

A PBPK Modeling Platform for Veterinary and Pre-clinical Drug Research Simcyp® Animal is a whole-body physiologically-based pharmacokinetic (PBPK) modeling platform for rat, dog, and knock-out mouse. It is based on the Simcyp Simulator with simplified interfaces and well-validated models. Simulations with Simcyp Animal can help identify key data requirements and inform the design of subsequent […]

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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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Simcyp PBPK Modeling and Simulation

Physiologically-based Pharmacokinetic (PBPK) Modeling: Getting Real Answers from Virtual Populations A recent FDA draft guidance for industry, “Physiologically-based pharmacokinetic analyses—format and content” highlights the regulatory currency that PBPK now garners: “Throughout a drug’s life cycle, PBPK model predictions can be used to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, […]

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