Certara, a Princeton, N.J.-based global technology-enabled drug development and drug safety consultancy, has launched version 1.4 of its Phoenix product family.

Phoenix is a PK/PD software platform used by more than 5,000 biopharmaceutical companies, veterinary and academic researchers, and U.S., European, Japanese and other pharmaceutical regulatory agencies to analyze, manage, report and validate preclinical 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 Edmundo Muniz, M.D., Ph.D., Certara CEO. “Our platform supports the concepts set forth in the Critical Path Initiative, an FDA 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.”

Upgrades in Phoenix 1.4 include:

• Alignment with recent FDA, EMA, 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.
• 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.