Under the terms of the CRADA, Pharsight will use its software to analyze, visualize, store, report, and review pharmacokinetic and pharmacodynamic data.
Pharsight will also provide CDER with its suite of software tools, including Pharsight Knowledgebase Server, the PKS Validation Suite, its WinNonlin Validation Suite, its Drug Model Explorer, and its Pharsight Trial Simulator. CDER will use the Pharsight tools to review clinical trial data, especially for clinical pharmacology and clinical safety reviews, and will provide feedback to Pharsight, the company said.
According to Robert Powell, head of pharmacometrics in FDA's Office of Clinical Pharmacology, the collaboration directly supports the FDA's Critical Path Initiative, which advocates increased use of drug-disease modeling and simulation to improve the efficiency of the drug product development process.
Financial details were not discussed.