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FDA and Pharsight Continue to Collaborate Under CRADA
Date:12/11/2007

nlin or PKS. FDA expects to use these installed Pharsight tools to review clinical trial data, especially for clinical pharmacology and clinical safety reviews, and will provide feedback to Pharsight.

"We remain excited about our ongoing collaboration with FDA and reaching our common goal of developing PKS into a repository for the vast amount of data needed for modeling and simulation projects," said Shawn O'Connor, president, CEO, and chairman of Pharsight. "We look forward to FDA's feedback on our other software tools, which should provide valuable insight as we continue to introduce enhancements to our existing products and launch new innovative tools. Currently, we are utilizing the Agency's feedback to further customize PKS to meet industry data management and analysis needs. We believe that our software tools offer tremendous value to drug developers and believe that FDA's positive engagement in our CRADA underscores this belief. Pharsight has already gained valuable insights by interacting with FDA through our CRADA and expects to continue to benefit from this relationship in the future."

Under the terms of the five-year CRADA, initiated in June 2006, Pharsight is collaborating with FDA using Pharsight software for the analysis, visualization, storage, reporting and review of pharmacokinetic/pharmacodynamic (PK/PD) data. A focal point of the collaboration is to develop Pharsight's enterprise PK/PD data management system, PKS, into a repository for the data needed for modeling and simulation, support Clinical Data Interchange Standards Consortium (CDISC) data formats, and interact with other FDA databases.

About PKS

PKS enables pharmaceutical and biotechnology companies to better manage and control preclinical and clinical PK/PD data and analyses, thus supporting higher modeling productivity as called for in FDA's Critical Path Initiative. Companies also use PKS to build PK/PD data management architecture that complies with FDA's r
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SOURCE Pharsight Corporation
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