HOME | PRESS RELEASES | HOW TO ORDER | EVALUATE | CONTACT US | CAREERS | Japanese

WinNonlin® — Industry-Standard PK/PD Modeling and Analysis

WinNonlin is the industry standard for pharmacokinetic, pharmacodynamic, and noncompartmental analysis. In addition to its extensive library of built-in PK, PD and PK/PD models, WinNonlin supports custom, user-defined models to address any kind of data.

WinNonlin is truly the industry standard.  First released in 1984, WinNonlin has been used by FDA since 1998.  Today there are over 6000 commercial and academic WinNonlin users in 1200 organizations worldwide. WinNonlin is referenced in 530 publications retreivable in PubMed.

Pharsight offers software evaluation licenses to commercial organizations

Submit WinNonlin® Evaluation Request

WinNonlin provides a complete solution with data management, statistical, modeling, and visualization tools in one package. Its worksheet interface facilitates data handling and transformations. Its descriptive statistics and linear mixed effects modeling engines provide flexible pre- and post-modeling analyses. The bioequivalence wizard supports FDA standards for average, individual and population bioequivalence assessment. Additional tools enable exploration of your drug’s properties through non-parametric superposition, semicompartmental modeling, deconvolution and nonparametric analysis of crossover studies. Finally, WinNonlin’s chart and table wizards, and automatic chart output from modeling, produce high-quality output for your study reports.

“We were impressed with its flexibility and the potential ease with which [WinNonlin] could interface with our standard software packages.”
Dr. Fran Stewart,
Clinical Pharmacokineticist,
Roche Products Limited, UK

For users of other tools, WinNonlin supports data exchange with additional industry-standard analysis software, including SAS, NONMEM®, S-PLUS® and SigmaPlot®.

Support for FDA Bioequivalence Regulations

WinNonlin accurately implements models to analyze bioequivalence based on replicated crossover studies, as required by the FDA for modified release dosage forms. Simply load your data and use the default model.

Enterprise Data Sharing and Storage

WinNonlin’s Enterprise edition links WinNonlin’s powerful modeling and analysis features to your data management infrastructure. WinNonlin Enterprise can exchange data with any ODBC-compliant database (e.g., Oracle®, SAS, etc.), and includes a software developer’s kit to build custom query tools—for example, a custom interface for a commercial LIMS product. WinNonlin Enterprise can read rows of PK data from an ODBC-compliant database, and save analysis output back to a table in that database.

For managing PK/PD data and analyses in a secure, compliant repository, WinNonlin Enterprise is fully integrated with Pharsight® Knowledgebase Server™ (PKS™). Together, WinNonlin and PKS provide secure, distributed access to your study data, with full audit trails of any changes to the data, as well as storage and version control for your models, analyses, results and related documents.

Automated Analysis and Reporting

WinNonlin analyses can be scripted, to speed production of text, graphical and tabular results. Further, as part of a complete data management, analysis and reporting solution, WinNonlin Enterprise, PKS and PKS Reporter™ enable automation of routine analysis and report generation.

Used in conjunction with PKS, Pharsight's WinNonlin® AutoPilot™ provides a configurable software solution for standardized, regulatory-compliant, secure and automatic generation of routine analyses and reports.

Used independently of PKS, WinNonlin AutoPilot provides the ability to interoperate with your data sources and can provide significant return on investment through productivity and quality improvements in PK analysis and reporting.

Training Resources

WinNonlin includes extensive on-line help and step-by-step tutorials to build user knowledge and skills. In addition, Pharsight offers courses in modeling methodology and hands-on use of WinNonlin.
Read More

As a guide to PK/PD theory and applications of modeling concepts using WinNonlin, Pharsight recommends Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, 4th Edition, by Johan L. Gabrielsson, Ph.D. and Daniel L. Weiner, Ph.D.  Read More

Benefits

  • Sophisticated modeling and analyses through a user-friendly interface
  • Trustworthy results from validated computational engines
  • Time-savings through analysis refresh, scripting and automation
  • Accelerated, standardized study reports
  • Direct access to securely-stored data and analyses for regulatory submissions
  • Standardized, automated analysis and reporting with Pharsight Knowledgebase Server

Read More

 

"SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ®indicates USA registration."