Representatives from FDA and Leading Pharmaceutical Companies Slated to
MOUNTAIN VIEW, Calif., Sept. 28 /PRNewswire-FirstCall/ -- Pharsight Corporation (OTC Bulletin Board: PHST), a leading provider of software and strategic services for optimizing clinical drug development, today announced that it will host its fourth annual Pharsight(R) Knowledgebase Server(TM) (PKS(TM)) User Group Meeting on October 3 and 4, 2007 at the Marriott at Metro Center in Washington, DC.
This annual meeting provides an environment for regulators, industry scientists and developers to gather and discuss challenges and advances in regulatory-compliant PK/PD data management. Case studies will be presented by attendees to exemplify the use of PKS and the decisive impact the software has had on facilitating improved productivity in their drug development processes. More information is available from firstname.lastname@example.org.
"This will be our fourth PKS User Group meeting and attendance is proving to be strong again this year," said Shawn O'Connor, Pharsight president, CEO and chairman. "We believe this confirms the growing importance of technology for improving the efficiency of the drug development process. PKS customers, FDA, and Pharsight personnel will once again have the opportunity to interact and share information which will drive future product development to increase the value of PKS."
PKS is a high-productivity, regulatory-compliant enterprise data repository that manages modeling and simulation data. 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 the FDA's Critical Path Initiative. FDA is using PKS under a Cooperative Research and Development Agreement (CRADA).
Companies also use PKS to build PK/PD data management architecture that complies with the FDA's regulation 21 CFR Part 11, which has set new standards for computer system validation and usage. PKS is directly integrated with WinNonlin(R) Enterprise(TM), Pharsight's industry-leading PK/PD modeling and analysis tool for state-of-the-art modeling and analyses, and supports direct access to any ODBC-capable data source. PKS also supports analysis with leading tools such as NONMEM(R) and SAS(R), and data import from leading clinical data management and laboratory information management systems such as Watson LIMS(TM). PKS software is designed to complement other Pharsight products, including Trial Simulator(TM) and Drug Model Explorer(R) (DMX(R)), which are used for computer-based drug-disease modeling, clinical trial simulation, and drug model visualization.
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, Pharsight Knowledgebase Server (PKS), WinNonlin Enterprise, Trial Simulator and Drug Model Explorer (DMX), are trademarks or registered trademarks of Pharsight Corporation. All other brand and product names are trademarks or registered trademarks of their respective holders.
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Jennifer Beugelmans, 646-201-5447 Jennifer Saunders
Doug Sherk, 415-896-6820 646-201-5431
|SOURCE Pharsight Corporation|
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