Phoenix WinNonlin

Phoenix WinNonlin DEV

Phoenix WinNonlin 8.1: The Industry Standard for NCA and PK/PD Modeling and Simulation Phoenix® WinNonlin® is the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling. Integrated tools for data processing, post-analysis processing, table creation, and graphics create an all-in-one collaboration workbench used by scientists, reviewers, medical writers, and quality assurance staff for […]

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Phoenix Modeling Language School

Learn How to Build Custom PK and PK/PD Models Phoenix WinNonlin® uses Phoenix Modeling Language (PML) to encode pharmacokinetic (PK) and Pharmacodynamic (PD) models. Although most models can be built using the graphical user interface (GUI) in Phoenix, there are some models that require custom coding with PML. Certara has launched a series of interactive […]

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Phoenix CDISC Workflow Templates

Automate the Preparation of NCA Clinical and Non-clinical Data in CDISC-ready Formats The Phoenix® CDISC Workflow Templates prepare non-compartmental analysis (NCA) data into the format required by the FDA for electronic submission of clinical (SDTM) or non-clinical (SEND) study data. Once your NCA is completed in Phoenix WinNonlin™, the CDISC Workflow Templates automate the creation of the SDTM […]

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Phoenix Technology Services

Phoenix Technology Services—Facilitating the Art and Science of Modeling and Simulation Phoenix® is the industry’s premier software platform for managing, analyzing and reporting pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) data. Phoenix Technology Services was established to help our clients leverage Phoenix software, systematize “best practices”, and to take advantage of modeling and simulation trends […]

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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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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 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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Phoenix WinNonlin

Phoenix WinNonlin 8.1: The Industry Standard for NCA and PK/PD Modeling and Simulation Phoenix® WinNonlin® is the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling. Integrated tools for data processing, post-analysis processing, table creation, graphics, and compliance create an all-in-one collaboration workbench used by scientists, reviewers, medical writers, and quality assurance staff […]

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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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Pharmacometrics Regulatory Strategy

Predictive Disease-Drug-Trial Modeling and Simulation A well-designed pharmacometrics regulatory strategy satisfies multiple goals. First, the strategy prioritizes the needs of the program and details when and how they will be met. Next, a strategic road map provides direction that ensures that studies and analyses will be fit-for-purpose and add value to the program. Finally, a […]

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