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Software enables in vivo-in vitro correlations.

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January 31, 2007 - Available as add-on to WinNonlin®, IVIVC Toolkit(TM) expands capabilities beyond pharmacokinetic, pharmacodynamic, and non-compartmental analysis, to development and application of in vivo-in vitro correlations. IVIVC Wizard offers point-and-click interface for IVIVC creation, evaluation, and utilization. Leveraging WinNonlin's modeling engine, toolkit allows scientists to build customized models to relate drug formulation's dissolution characteristics to in vivo pharmacokinetic profile.

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Original Press release

Pharsight Corp.
321 E. Evelyn Ave.
Mountain View, CA, 94041-1530
USA



Pharsight Releases IVIVC Toolkit(TM) for WinNonlin(R)


MOUNTAIN VIEW, Calif., Jan. 25 /- Pharsight Corporation (BULLETIN BOARD: PHST) , a leading provider of software and strategic services for optimizing clinical drug development, today announced the release of IVIVC Toolkit(TM) for WinNonlin(R). The IVIVC Toolkit is an optional add-on to WinNonlin that expands its capabilities beyond pharmacokinetic, pharmacodynamic, and non-compartmental analysis, to the development and application of in vivo-in vitro correlations. In vivo-in vitro correlations are used in various applications including formulation development and bioequivalence testing.

The IVIVC Toolkit expands on WinNonlin's deconvolution capabilities, while adding convolution and IVIVC specific analysis plots. In addition to providing tools for scientists to use in their analyses, the IVIVC Toolkit contains an "IVIVC Wizard," a point-and-click interface for IVIVC creation, evaluation, and utilization. The IVIVC Wizard also manages the data and workflow, allowing the project files to be shared amongst various working groups while keeping track of the status of the work.

"The IVIVC Toolkit provides unmatched power and flexibility for in vivo-in vitro correlation development within the familiar and user-friendly WinNonlin environment," said Dan Weiner, Ph.D., senior vice president for software products at Pharsight Corporation. "We developed the IVIVC Toolkit in direct response to requests from many of our clients and have tailored the program to meet their needs. The IVIVC Toolkit augments WinNonlin's capabilities and increases its value for a whole new group of users working in formulation development, line extension, and generic drug development. IVIVC Toolkit illustrates Pharsight's commitment to our strategy of expanding our market with software products that serve the unmet needs of our clients."

About the IVIVC Toolkit for WinNonlin
The IVIVC Toolkit has been developed in collaboration with scientists working in the pharmaceutical industry. Leveraging WinNonlin's powerful modeling engine, the IVIVC Toolkit allows scientists to build customized models to relate a drug formulation's dissolution characteristics to the in vivo pharmacokinetic (drug concentration) profile. A validated IVIVC can be used to predict the in vivo behavior of a formulation to assess the likelihood of success before entering it in a biostudy. With the IVIVC Wizard (provided as part of the IVIVC Toolkit) scientists can quickly explore their data and find a suitable model.

In conjunction with the Pharsight Knowledgebase Server(TM) (PKS(TM)) the IVIVC Toolkit can be used as part of a workflow that is compliant with CFR 21 Part 11.

About Pharsight Corporation
Pharsight Corporation develops and markets integrated products and services that enable pharmaceutical and biotechnology companies to achieve significant and enduring improvements in the development and use of therapeutic products. The company's goal is to help customers reduce the time, cost and risk of drug development, as well as optimize the post-approval marketing and use of pharmaceutical products.

Pharsight's approach enhances the fundamental element of drug development success: strong decision-making. By adopting the Pharsight approach, customers acquire a new decision-making process with the potential to systematically improve every level and phase of their business and scientific processes. Pharsight is headquartered in Mountain View, California. Information about Pharsight is available at http://www.pharsight.com/.

Registered Trademarks and Trademarks
Pharsight, WinNonlin, IVIVC Toolkit for WinNonlin, IVIVC Wizard, Pharsight Knowledgebase Server, and PKS are registered trademarks or trademarks of Pharsight Corporation.

Web site: http://www.pharsight.com/
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