PK Accelerator Bundled Solution Accelerates Pharmacokinetic Analysis and
MOUNTAIN VIEW, Calif., June 24 /PRNewswire-FirstCall/ -- Pharsight Corporation (Nasdaq: PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that it will be launching PK Accelerator (PKA(TM)), a system of bundled software coupled with a rapid deployment service provided at a fixed price and fixed scope. Adopting PK Accelerator will allow small to mid-sized organizations to deploy Pharsight's "best practices" solution for end-to-end pharmacokinetic analysis and validatable CFR 21 part 11 reporting in as little as 90 days.
Small to mid-sized research oriented pharmaceutical and biotech companies deploying PK Accelerator will be able to take advantage of the operational efficiencies Pharsight's enterprise and desktop software packages were designed to deliver. The software components of the PKA bundle will consist of the Pharsight(R) Knowledgebase Server(TM) (PKS), WinNonlin(R) Autopilot(TM), PKS Reporter(TM), the PKS and WinNonlin Validation Suites(TM), upgrades to WinNonlin Enterprise, and a choice of two of the following database connectors: Watson(TM), Excel(TM), or CDISC. All of these components have been designed for seamless interoperability and will be implemented as a complete system with minimal configuration. PK Accelerator will bring state-of-the-art clinical pharmacology archiving, analysis, and reporting capabilities within reach of smaller firms by standardizing the system's training and deployment procedures and leveraging Pharsight's best practices recommendations for system configuration and implementation. Standardized connector settings and transformations, standardized validation scripts, standardized software settings, standardized analysis and reporting templates and standardized business rules will all work together to improve the ROI for Pharsight's PK accelerating technologies.
"PK Accelerator allows you to integrate data into standardized PK-ready analysis formats, perform the analysis, and generate final NCA reports in as little as a day," said Shawn O'Connor, president, chief executive officer and chairman of Pharsight. "Pharsight is leveraging its lessons learned on 22 previous PKS and numerous AutoPilot and Reporter deployments and streamlining the process in order to accommodate the needs of small to mid-sized pharma and biotech companies."
Pharsight(R) Knowledgebase Server(TM) (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. 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 Enterprise, 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 WinNonlin AutoPilot
WinNonlin(R) AutoPilot(TM) orchestrates PK analyses by selecting input data from a user's local file system or Pharsight Knowledgebase Server(TM) ("PKS"), and then directs WinNonlin to perform analyses and produce report quality tables, figures, and text output (e.g., in Microsoft(R) Excel(TM), SigmaPlot(R), and Microsoft Word(TM)) for regulatory submissions and interim reports. Formatted PK analyses outputs must reflect the requirements and SOPs of each research organization, and WinNonlin AutoPilot provides a user interface that allows extensive configuration of formatting and business rules to enable clear communication of standards and immediate use across the organization. PK analyses that can be automated include noncompartmental analysis for different study designs and inferential statistics (e.g., bioequivalence testing), as well as comparisons between analytes, dose routes or other conditions. Used in conjunction with PKS and PKS Reporter(TM), WinNonlin AutoPilot provides standardized, regulatory compliant, secure and automatic generation of routine analyses and reports. Used independently of PKS and PKS Reporter, WinNonlin AutoPilot can provide significant return on investment through productivity gains and quality improvements in PK analysis and reporting.
About PKS Reporter
PKS Reporter(TM) addresses the need for streamlined, systematic, and automated report generation and signature. Using PKS as an underlying source of secure, regulatory-compliant report content, PKS Reporter allows researchers to use familiar tools such as WinNonlin and Microsoft Word(R) to construct, update, review and approve any type of report.
About WinNonlin Validation Suite
The WinNonlin Validation Suite(TM) streamlines your on-site validation of the WinNonlin product. The Validation Suite provides a selection of automated tests, each of which runs a specific WinNonlin analysis or function and tests the results against standardized, known output.
About PKS Validation Suite
The PKS Validation Suite(TM) streamlines your on-site validation of the PKS product. The Validation Suite provides document templates, test data, and a collection of automated and manual test scripts. Leveraging the PKS Validation Suite as a starting point for validation efforts can save months of planning, testing, and reporting time.
About Pharsight Corporation
Pharsight(R) 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.
The statements in this press release related to the functionality, performance, and benefits of the PK Accelerator(TM) bundled software are forward-looking statements. Forward-looking statements are inherently speculative, and the actual results and customer's experience may differ materially from Pharsight's expectations due to a variety of factors, including: changes in FDA regulations and customers may not perceive the benefits of the IVIVC Toolkit(TM) for WinNonlin(R) to be the same as Pharsight believes them to be. Other risk factors relating to Pharsight are disclosed in the company's most recent Form 10-Q filed with the Securities and Exchange Commission on February 14, 2008. All forward-looking statements are based on information available to the company on the date hereof, and the company assumes no obligation to update such statements.
Registered Trademarks and Trademarks
Pharsight is a registered trademark of Pharsight Corporation. All other brand and product names are trademarks or registered trademarks of their respective holders.
|SOURCE Pharsight Corporation|
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