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

FDA Modeling and Simulation Infrastructure Now Incorporates Three Pharsight

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MOUNTAIN VIEW, Calif., Dec. 11 /PRNewswire-FirstCall/ -- Pharsight Corporation (Nasdaq: PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today provided an update on its Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). The CRADA collaboration directly supports 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.

Since the initiation of the five-year CRADA in June 2006, Pharsight has successfully worked with FDA to install Pharsight(R) Knowledgebase Server(TM) (PKS(TM)) into the Agency's IT environment. PKS is a market-leading, high- productivity, regulatory-compliant enterprise data repository that manages modeling and simulation data. Pharsight has conducted training classes for FDA staff on PKS and has also trained FDA staff on WinNonlin(R) and Trial Simulator(TM), which FDA had previously installed. Pharsight has also introduced Drug Model Explorer(R) (DMX(R)) to FDA.

Importantly, Pharsight has worked with FDA to streamline the process of loading data from New Drug Applications (NDAs) into PKS by integrating the FDA's internal data management tools with Pharsight's PKS data connector technology. This integration allows FDA reviewers to build analysis datasets from NDAs submitted in Clinical Data Interchange Standards Consortium (CDISC) and non-CDISC formats. These analysis datasets can then be imported into WinNo
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SOURCE Pharsight Corporation
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