Previous iterations took up to two days to execute. Now validation can be completed in less than 30 minutes. This approach can also assist regulators by clearly stating what process and acceptability criteria were used.įor the first time, the Phoenix WinNonlin Validation Suite is included within the Phoenix software. In addition, scientists can set strict criteria for the terminal slope calculation in NCA to ensure compliance with their organization’s policies and procedures. Scientists can also define their own NCA parameters such as compute concentrations at any time point.
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By cutting post-processing activities, this update can decrease analysis time by about 25%. The NCA engine now automatically calculates more than a dozen new additional parameters for plasma and urine. Phoenix WinNonlin 8.0 includes several non-compartmental analysis (NCA) advances that were made in response to our ‘Voice of Customer’ analysis, which included valuable input from users all over the world. This function is unique in its ability to automate these complex analyses. This simplifies coding delays in PK/PD models and can be used in place of transit compartments, dual absorption models, effect compartment models, and indirect response models. Phoenix NLME 8.0 also includes a distributed delay function to model delayed outcomes in therapeutic areas such as oncology, diabetes and arthritis. They can then revise their hypothesis if necessary and move onto the next step. This allows modelers to complete their analysis and scientific exploration in real time. Phoenix can also combine the two approaches, enabling models to be run in parallel and on multiple cores, reducing model run time by 80-90%. Scientists can now use computation grids with hundreds of processors to get their analysis done in a fraction of the time. It also permits within model parallel action so the analysis work for one model can be divided between several CPUs. It supports between model parallelizing, allowing two models to be run together on different processors. Phoenix NLME 8.0 takes advantage of grid computing in several ways.
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It has been only 12 months since the last Phoenix release, and we have added several important new features to the software to allow key drug development decisions to be made quicker,” said David Munro, President of Phoenix Technologies at Certara. “Phoenix is considered the gold standard in PK/PD modeling and simulation, and we take our responsibility to deliver continuous improvement and innovation very seriously. This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials,” said US FDA Commissioner Scott Gottlieb, M.D. “Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs. Phoenix is also employed by many global regulatory agencies for submittal review, including 11 divisions of the FDA. Phoenix is used by 6,000 researchers at 1,500 biopharmaceutical companies and academic institutions in 60 countries. Included in this Phoenix rollout are Phoenix WinNonlin 8.0, Phoenix NLME 8.0, Phoenix Validation Suite 8.0 and Phoenix in vitro-in vivo correlation (IVIVC) Toolkit 8.0. Phoenix is the most advanced, intuitive, and widely-used software for pharmacokinetic (PK), pharmacodynamic (PD) and toxicokinetic (TK) modeling and simulation. Certara, a global provider of model-informed drug development and regulatory science, announced the launch of Phoenix 8.0.
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