Release includes updates to Phoenix WinNonlin, the gold standard for pharmacokinetic and pharmacodynamic (PK/PD) modeling used in preclinical and clinical drug development
PRINCETON, NJ – Nov. 3, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, today announced the launch of version 1.4 of its Phoenix® product family at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition being held at the San Diego Convention Center from Nov. 2-6.
Phoenix is the premier PK/PD software platform used by more than 5,000 biopharmaceutical companies, veterinary and academic researchers, and US, European, Japanese and other pharmaceutical regulatory agencies to analyze, manage, report and validate pre-clinical and clinical PK, PD and toxicokinetic (TK) data.
“Our clients choose the Phoenix platform because it allows them to optimize the most crucial drug development decisions in order to bring breakthrough drugs to patients,” said Certara CEO Edmundo Muniz, M.D., Ph.D. “Our platform supports the concepts set forth in the Critical Path Initiative, a U.S. Food and Drug Administration program focused on the development of tools to streamline drug development. In order to meet global regulatory goals, we regularly update our Phoenix tools to maximize efficiencies and ensure that they continue to meet our customers’ evolving needs.”
Key benefits/upgrades in Phoenix 1.4 include:
- Alignment with recent FDA (US), EMA (Europe), NIHS (Japan) and HPFB (Canada) guidance on the design, conduct and evaluation of bioavailability (BA) and bioequivalence (BE) studies for orally-administered drug products. BA and BE studies are required by regulators in support of IND, NDA and ANDA filings.
- Addition of a new user interface to automate sequential PK/PD analysis in Phoenix NLME. This enhancement expands both the depth and breadth of these analyses, and expedites delivery of results.
- Use of dynamic memory allocation in Phoenix NLME that will vastly reduce the memory needed to fit models, thereby increasing performance and efficiency.
- New file import functionality that enables users to significantly reduce the amount of time spent in data preparation.
- A new Watson LIMS plug-in within Phoenix Connect that allows users to connect to the widely-used Watson LIMS database, extract study data, and create a worksheet that is ready for analysis. This enhancement reduces the manual or programming activity required, resulting in measurable productivity gains.
- Improvements to CDISC capabilities within Phoenix Connect that allow users to create analysis-ready worksheets automatically when importing CDISC-formatted study data and also to export analysis results in CDISC formats to support faster regulatory filings.
The Phoenix 1.4 release consists of Phoenix® Connect 1.4, Phoenix WinNonlin® 6.4, Phoenix NLME™ 1.3, Phoenix QT+™ 1.1, the IVIVC Toolkit™ 2.2 for Phoenix WinNonlin, and AutoPilot™ Toolkit 2.2 for Phoenix. Updates have also been made to the platform’s job management system and remote processing server.
Introducing Phoenix Quantum
In addition to upgrading the Phoenix platform, Certara is announcing the availability of Phoenix Quantum. These solutions have been organized to align with the workflows used by leading scientists and are now offered in attractively-priced options.
Using Phoenix products helps companies save time and money by encouraging scientific collaboration and increasing analysis efficiency. With Phoenix Quantum, key Phoenix products become even more accessible to users within a company. These solutions are designed to offer flexibility, visibility and predictability in the procurement of an organization’s software licenses.
AAPS Annual Meeting and Exposition attendees can participate in Phoenix 1.4 demonstrations at Certara booth #3537.
Certara is the leading global technology-enabled drug development and drug safety consultancy. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety.
Teresa A. Bradford, 919-852-4644
Senior Director, Marketing
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions