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Phoenix WinNonlin: 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 drug development projects.

Trusted by Scientists and Regulators around the Globe With a proven 30-year global history, Phoenix WinNonlin is used by over 6,000 scientists at nearly 2,000 institutions in 60 countries, including the top pharmaceutical companies and 200 academic institutes. Regulatory agencies, including 11 divisions of the US Food and Drug Administration (FDA), Japan Pharmaceutical and Medical Device Agency (PMDA), China Food and Drug Administration (CFDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), use Phoenix WinNonlin to evaluate drug submissions. The Most Comprehensive Set of Analysis Tools for Non-clinical and Clinical PK/PD Study From early non-clinical research to large clinical trials, Phoenix WinNonlin’s NCA engine, individual PK/PD modeling engine, and statistical analysis tools can be used for a wide-range of studies and analyses.

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The upgraded NCA engine automatically outputs additional NCA parameters for plasma and urine to save time, reduce errors, and provide higher transparency for regulatory agencies. Furthermore, Phoenix WinNonlin includes the capability for user-defined parameters, and organizations can set strict criteria for the calculation of the terminal slope in NCA. Powerful Integrated Graphics Engine and Table Generator The integrated graphics engine in Phoenix WinNonlin automatically creates publication-quality plots and figures and well-organized tables to help create standardized PK/PD reports more efficiently. The output can be quickly and easily attached to a PK/PD report for communicating results internally and to regulatory agencies. Data Processing and Preparation Tools Dataset preparation is a breeze with Phoenix WinNonlin’s data processing tools.

Users can directly import SDTM-formatted datasets and prepare analysis-ready datasets by using the simple graphical user interface in Phoenix WinNonlin. The Phoenix workflow traces data from the moment it is imported through the final analysis, preventing data loss and costly re-analysis. Phoenix Tools to Support Compliance Phoenix offers features and applications to ensure that organizations are compliant with organizational and regulatory policies.

The Phoenix Workbench allows for locking of workflows with a password to ensure consistency and quality control. The is integrated into Phoenix and uses automated technology to complete validation in minutes, not days. And full integration of Phoenix WinNonlin with the enables the management of clinical and non-clinical PK and PD data and analyses in compliance with the US FDA electronic records and signatures regulation (21 CFR Part 11).

Lastly, there are Phoenix workflow templates to 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 automate the creation of the SDTM or SEND Pharmacokinetic Parameters (PP) and Pharmacokinetic Concentration Data (PC) domains in the required SDTM or SEND format. We’re committed to your success We provide a wide range of and tools to get you started, and our informative and keep you up to date with the most important advancements in modeling. To learn why Phoenix WinNonlin is the trusted, proven industry standard software tool for PK/PD modeling and non-compartmental and compartmental analysis.

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