Pharsight announces research agreement with FDA
Under the terms of the agreement, CDER and Pharsight will collaborate on future versions of Pharsight's WinNonMix and Pharsight Trial Simulator products over a three-year term. The collaboration plans to address evolving industry and regulatory needs for population PK/PD (pharmacokinetic/pharmacodynamic) modeling and clinical trial simulation.
"This collaboration is expected to benefit both organizations and potentially the pharmaceutical industry as well," said Daniel Weiner, Senior Vice President of Technology Deployment at Pharsight. "By combining the needs of the agency with the needs of the industry, we can create better products for clinical development, design and evaluation."
According to Pharsight, the results from population PK/PD studies can be valuable in planning later phases of clinical trials. By using these software tools to explain the measurable factors that may be related to both the change and the magnitude of change in outcomes, it is possible to achieve more appropriate directions for dosage, administration and labelling for new drugs.
"While population modeling and trial simulation tools have become increasingly important to the pharmaceutical development process, technological advances now make it possible to develop additional user-friendly scientific software to help integrate these multiple sources of input into the planning and review processes," Weiner said. "This could enable more efficient clinical trial design and evaluation."