Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence services, today announced the launch of Phoenix® 8.1.
Phoenix is the most advanced and widely-used validated software for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) modeling and simulation worldwide. 90% of novel drugs approved by the US FDA are from companies that leverage Phoenix in their R&D programs.
“Certara’s mission is to improve decision-making throughout the drug development continuum; we are involved at every step from selecting the best drug candidate to demonstrating its value to payers and health authorities. To that end, we are committed to providing a full range of modeling and simulation technology, advisory services, compliance support, and training programs to ensure that scientists optimize their work. We are proud to launch Phoenix 8.1, which offers significant statistical, graphical and validation enhancements to automate processes, saving both time and resources,” said Thomas Kerbusch, PhD, President of Certara Strategic Consulting.
Phoenix is used by 6,000 researchers at 1,500 biopharmaceutical companies and academic institutions in 60 countries. Key to its wide adoption is the native graphical user interface (GUI) and easy-to navigate workflow templates that enable all modelers—both new and experienced—to quickly and accurately leverage the software. Furthermore, the Phoenix team provides users with robust documentation, technical and educational support, and a continuing community to leverage best practices. Phoenix is also employed by many global regulatory agencies for submittal review, including the European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency, China Food and Drug Administration, and 11 divisions of the US Food and Drug Administration.
Included in the Phoenix 8.1 rollout are a new Ratios Tool for noncompartmental analysis (NCA), an enhanced Validation Suite for Phoenix WinNonlin®, and an improved Visual Predictive Check (VPC) in Phoenix NLME™.
New NCA Ratios and Differences Tool
Ratio calculations on PK parameters are essential for study reports and for interpreting results, but calculating them can be time-consuming, taking too many steps and external tools. Phoenix WinNonlin delivers one-step, automated calculation of NCA ratios for renal clearance, accumulation ratio, gender differences, linearity index, and parent to metabolite exposure ratios. This new tool eliminates the need to create a workflow or use external tools, resulting in greater efficiency and time savings. For example, scientists can access a report-ready table of exposure parameters and easily identify any gender differences within seconds and use those data to create plots to highlight the differences.
Phoenix WinNonlin 8.1 also provides additional automated statistical calculations, such as geometric SD, user-specified percentiles, and an option to select statistics for outputs. Certara has upgraded the Phoenix graphics engine which now allows chart controls by sort or group variable, order profiles in legend, error bars for bar/column plots, and offset for any overlaid plot.