Phoenix 8.0 provides scientists with more power, efficiency and transparency into PK/PD analysis and modeling for regulatory review
PRINCETON, NJ – 2017 年 10 月 3 日 – Certara®, the global leader in model-informed drug development and regulatory science, today announced the launch of Phoenix® 8.0. Phoenix is the most advanced, intuitive, and widely-used software for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) modeling and simulation. 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 used by 6,000 researchers at 1,500 biopharmaceutical companies and academic institutions in 60 countries. Phoenix is also employed by many global regulatory agencies for submittal review, including 11 divisions of the US Food and Drug Administration (FDA).
“Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs. This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials1,” said US FDA Commissioner Scott Gottlieb, MD.
“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. 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.
Expedites Data Analysis
Phoenix NLME 8.0 takes advantage of grid computing in several ways. It supports between model parallelizing, allowing two models to be run together on different processors. It also permits within model parallel action so the analysis work for one model can be divided between several CPUs. Scientists can now use computation grids with hundreds of processors to get their analysis done in a fraction of the 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%. This allows modelers to complete their analysis and scientific exploration in real time. They can then revise their hypothesis if necessary and move onto the next step.
Phoenix NLME 8.0 also includes a distributed delay function to model delayed outcomes in therapeutic areas such as oncology, diabetes and arthritis. 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. This function is unique in its ability to automate these complex analyses.
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.
The NCA engine now automatically calculates more than a dozen new additional parameters for plasma and urine. By cutting post-processing activities, this update can decrease analysis time by about 25%. Scientists can also define their own NCA parameters such as compute concentrations at any time point.
In addition, scientists can set strict criteria for the terminal slope calculation in NCA to ensure compliance with their organization’s policies and procedures. This approach can also assist regulators by clearly stating what process and acceptability criteria were used.
Accelerates Validation Automation
For the first time, the Phoenix WinNonlin Validation Suite is included within the Phoenix software. Now validation can be completed in less than 30 minutes. Previous iterations took up to two days to execute. Furthermore, Phoenix WinNonlin Validation Suite 8.0 can be run in the background, allowing scientists to continue using other programs on their computer. Lastly, Phoenix validation results are now date stamped and stored on the scientist’s computer, providing easy access if a validation needs to be re-run.
Maintains Consistency and Facilitates QC
The Phoenix application has many settings for each object, making it time consuming to replicate a plot or table. Scientists can now save all their object settings for use later or apply them to the existing object with one click. This ensures high quality output with less time and effort.
Scientists can also lock workflows in Phoenix 8.0 Workbench. Therefore, they can be confident that their settings haven’t changed without the painstaking quality control process that used to be required.
Certara will demonstrate the new Phoenix 8.0 features during a one-hour webinar beginning at 11 a.m. EDT on Nov. 1. Interested parties can register for the webinar at https://www.certara.com/webinars/how-can-you-get-the-most-out-of-phoenix-8-0.
 Gottlieb blog post: “How FDA Plans to Help Consumers Capitalize on Advances in Science.” FDA Voice. 2017 年 7 月 7 日.
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies.
Ellen Leinfuss, 609-216-9586
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Lisa Osborne, 206-992-5245
Rana Healthcare Solutions