Pharsight Significantly Increases Functionality of Industry-Leading Pk/Pd Modeling Software

Pharsight Corporation , a leading provider of software and strategic services designed to optimize clinical drug development, today announced the release of WinNonlin 5.0. WinNonlin provides major enhancements to modeling capabilities and data transformations and is now more fully integrated with leading data analysis and graphing software products including S-PLUS(R) and SigmaPlot. In addition, WinNonlin is also fully integrated into Pharsight’s industry-leading PK/PD data management application, Pharsight(R) Knowledgbase Server 3.0(TM) (PKS(TM)), the industry’s leading clinical pharmacology data repository.

WinNonlin is the industry standard analysis tool for pharmacokinetic (PK) and pharmacodynamic (PD) modeling and Noncompartmental Analysis, used by over 1,000 pharmaceutical and biotech organizations, as well as academic institutions. The application is used by researchers and developers to perform most of the analyses, and generate all data needed for PK and PK/PD studies. WinNonlin 5.0 has additional functionality to perform Noncompartmental Analyses for drug effect or PD data, as well as provide NCA analysis of sparsely-sampled data, such as toxicokinetic data. In addition, WinNonlin 5.0 offers a new multi-transformation tool that allows users to produce new workbooks utilizing both transformed and untransformed data. It is also more fully integrated with S-PLUS(R) and SigmaPlot, two leading analysis and graphing software products as well as PKS 3.0, increasing the seamless usage and analysis of study data. By increasing the functionality of WinNonlin, Pharsight has created a valuable research and development tool that allows scientists to reduce the time needed for data management and analysis of clinical pharmacology studies as well as increase the resources available for drug development activities.

“WinNonlin 5.0 was created to support newly defined needs of our pharmaceutical development customers,” said Shawn M. O’Connor, President and Chief Executive Officer of Pharsight. “As an organization, we pride ourselves on our ability to quickly respond to our customers’ emerging needs and the evolution of the marketplace. We believe this release, as well as our recent PKS 3.0 release, are clear evidence of our ability to achieve this goal. As the market leader for PK/PD analysis software, we are committed to remaining on the forefront of development and introducing novel technology to our clients aimed at reducing costs and allowing our customers to focus on their core competencies — drug development. With the significant enhancements we have introduced with WinNonlin 5.0, we believe we have achieved this goal and are providing significant value to our customers.”

Key new features and functionality of WinNonlin 5.0 include:

  • Noncompartmental Analysis for Drug Effect Data:  WinNonlin’s analysis engine now supports analysis of PD data, including calculation of selected slopes and areas
  • Noncompartmental Analysis for Sparse Data:  WinNonlin now computes the mean concentration curve, as well as the area under the curve and its standard error, for sparsely-sampled drug concentration data such as that which is collected in toxicokinetic studies.
  • Enhanced Data Transformations:  WinNonlin’s new multi-transformation tool simultaneously transforms data from multiple columns, producing a new workbook with any combination of transformed and untransformed data.  WinNonlin 5.0 also offers the ability to filter records to produce a subset of original data, as well as functionality that allows the user to transform columns using free-form equations.
  • Integration with S-PLUS and SigmaPlot:  WinNonlin 5.0 can pass data to Sigma Plot or S-PLUS, can return output to WinNonlin, and can quickly reproduce S-PLUS and SigmaPlot runs and return S-PLUS analyses, scripts and results into PKS.
  • Residual Normality Test:  WinNonlin now includes a Komogorov-Smirnov normality test, for use in testing residual normality in Linear Mixed Effects and Bioequivalnce analyses.
  • PKS Enhancements:  WinNonlin offers improved performance and an enriched feature set in a variety of PKS operations

About Pharsight Corporation

Pharsight Corporation is a leading provider of software products and consulting services that help pharmaceutical and biopharmaceutical companies improve and accelerate their decision-making in drug development and commercialization. By integrating scientific, clinical and business decision criteria into a dynamic, model-based methodology, Pharsight helps its customers optimize the value of their drug development programs and portfolios from discovery to post-launch marketing and any point in between. Pharsight’s computer-based drug-disease models, dynamic predictive market models, clinical trial simulation and advanced valuation models create a continuously evolving view of its customers’ development efforts and product portfolios. Pharsight’s range of software offerings includes the Drug Model Explorer(TM) Web Server (DMX(TM)), Pharsight Knowledgebase Server(TM) (PKS(TM)), PKS Reporter(TM), Trial Simulator(TM), and WinNonlin(R) and WinNonMix(R) modeling tools. Related software services include pharmacokinetic automation services and training courses. Information about Pharsight is available on the World Wide Web at www.pharsight.com .

Pharsight, WinNonlin and WinNonMix, Pharsight Knowledgebase Server, PKS, Drug Model Explorer, DMX, PKS Reporter and Trial Simulator are registered trademarks or trademarks of Pharsight Corporation.

All other brand and product names are trademarks or registered trademarks of their respective holders.

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