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 for drug development projects.

Relied on by Scientists and Regulators around the Globe

With a proven 30-year history, Phoenix WinNonlin is used by over 6,000 scientists at more than 1,500 establishments in 60 countries, including top pharmaceutical companies and 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), all use Phoenix WinNonlin to evaluate drug submissions.

Intuitive. Flexible. Sophisticated.

From beginners to advanced modelers, Phoenix WinNonlin provides the most comprehensive set of analysis tools for early non-clinical research to large clinical trial PK/PD studies.

  • Our NCA and individual PK/PD modeling engine and statistical analysis tools can be used for a wide-range of studies and analyses
  • The powerful NCA engine automatically outputs additional NCA parameters for plasma and urine to save time, reduce errors, and provide higher transparency for regulatory agencies
  • Organizations can set strict criteria with user-defined parameters for calculating the terminal slope in NCA
  • NCA ratios are automatically calculated increasing efficiency and saving time

Powerful Integrated Graphics Engine and Table Generator

The integrated graphics engine in Phoenix WinNonlin automatically creates publication-quality plots, figures and tables to create standardized PK/PD reports. Phoenix 8.1’s enhanced charting capabilities provide the ability to utilize the offset function, change font size and style, change the order and presentation of categorical axes, and more. The outputs can be quickly attached to a PK/PD report for communicating results internally and to regulatory agencies.

X-Categorical Plot with Order Change

Data Processing and Preparation Tools

Dataset preparation is intuitive with Phoenix WinNonlin’s data processing tools:

  • Users can utilize the simple graphical user interface to import SDTM-formatted datasets and prepare analysis-ready datasets. The Phoenix workflow traces data from the moment it is imported through final analysis, preventing data loss and costly re-analysis.
  • The new one-step ratios plugin provides quick and easy calculation of NCA ratios including bioavailability, accumulation, linearity index, and parent/metabolite comparisons.
  • Our Enhanced Descriptive Statistics provide automated calculations for sample and population statistics for skewness and kurtosis, user-specified percentiles, and more.

Phoenix Tools to Support Compliance

Phoenix offers features and applications to ensure that organizations are compliant with organizational and regulatory policies:

  • The combination of Phoenix WinNonlin with the Phoenix Knowledgebase Server (PKS) enables management of clinical and non-clinical PK/PD data and analyses in compliance with the US FDA electronic records and signatures regulation (21 CFR Part 11)
  • Passwords can be used to lock workflows, ensuring consistency and quality control
  • The integrated and enhanced Validation Suite for WinNonlin completes validation in minutes, not days. Robust reports and updated validation documents in Phoenix ensure alignment with regulatory guidance.
  • Phoenix’s CDISC Workflow Templates automate the creation of SDTM or SEND Pharmacokinetic Parameters (PP) and Pharmacokinetic Concentration Data (PC) domains in the FDA-required SDTM or SEND format

We’re committed to your success

We provide a wide range of education and support tools to get you started, and our informative blog and instructive webinars keep you up to date with the most important advancements in modeling. The new Certara Professional Certification program offers online accreditation of user competency and proficiency analysis of PK/PD data using Phoenix WinNonlin 8.0 and 8.1.

Contact us 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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