Latest updates demonstrate commitment to customers and market leadership of Phoenix Platform
PRINCETON, N.J.—六月 24, 2020. Certara®, the global leader in biosimulation, today announced the launch of version 8.3 of its Phoenix™ platform, the industry gold standard in pharmacokinetic/ pharmacodynamic (PK/PD) and toxicokinetic modeling and simulation software. Version 8.3 delivers new features to drive efficiencies and quality and save valuable time. Upgrades to the platform were driven by user input and platform strategy.
The Phoenix platform is used worldwide by more than 6,000 scientists at biopharmaceutical companies, academic and non-profit institutions, and regulatory agencies. Eleven regulatory agencies, including the U.S. FDA, PMDA in Japan, and NMPA in China, rely on the Phoenix platform to evaluate life-saving drug candidates. In 2019, Thailand became the most recent regulatory agency to adopt the platform.
“The Phoenix platform is increasingly being recognized as the premier software to review new drug and biologics license applications,” said William F. Feehery, PhD, Certara’s chief executive officer. “This new version is a testament to our scientific and technical expertise and our close collaboration with our customers. We are proud to launch version 8.3 and look forward to fostering new partnerships to provide biosimulation software that accelerates the drug development process.”
Key Phoenix 8.3 updates include the following:
- Phoenix NLME: The Phoenix NLME population pharmacokinetics application has new analytical capabilities such as additional visual predictive check features and distributed delay capabilities, including the delayInfCPt statement from gamma distribution to Weibull and Inverse Gaussian distributions, and improved steady state analysis capability. Distributed delays are particularly relevant in modeling therapies in oncology, diabetes, and arthritis and these automated features simplify coding.
- Phoenix Built-In Plots: Users now have more options to customize their data plots to present their data and submit reports to regulatory agencies.
- Open Source Plotting: To support the growing popularity of R and R Shiny for scientific plotting in posters and publications, Phoenix v 8.3 allows users to easily send data to R for exploratory data analysis and import plots back into the Phoenix platform.
“Certara partners with regulatory agencies and our customers to ensure they are fully utilizing all of the capabilities the Phoenix platform offers,” said Michael K. Eckstut, head of the software division at Certara. “By working closely and continuously with our users, we obtain valuable feedback and input to further advance our software to better fit our users’ analysis, modeling, and data management needs. We also provide extensive training to support their professional development.”
Certara University provides training in PK/PD and the Phoenix software to scientists worldwide. In an effort to continue educating the research community during the COVID-19 pandemic, Certara University offered its professional certification and eLearning courses at no cost to customers during April and May. In those two months, 4,464 people took free Certara University eLearning courses, and 138 people passed and received Phoenix professional certifications.
For more information on the Phoenix platform, please visit https://www.certara.com/phoenix-primary/.
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. 实际上，在过去六年，美国食品药品监督管理局 (FDA) 批准的所有新药中有 90％ 以上都是由 Certara 软件或服务提供支持的。Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.