The U.S. Food and Drug Administration continues its build-out of software capabilities for the evaluation of drug candidates. Software maker Pharsight has delivered two data analysis tools to the regulator: Phoenix NLME and Phoenix Connect, deliverables under an ongoing cooperative research and development agreement with CDER.
Phoenix NLME 1.0, launched last November, is data processing and modeling software for population pharmacokinetic and pharmacodynamic (PK/PD) analysis. Phoenix Connect sits atop common PK/PD modeling tools, allowing users to save work done with different tools in one project file that can be shared, rerun, changed, and saved as part of a workflow template that can be reused later with other datasets.
The FDA will use the software to analyze, store and report pharmacokinetic and pharmacodynamic data. The automated tools will complement those from other suppliers; combined, they are expected to equip the FDA with a capability for clinical pharmacology and clinical safety reviews of investigational and new drug applications.
- here's the Pharsight announcement