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IVIVC Toolkit™ for WinNonlin® — In Vivo-In Vitro Correlations

The IVIVC Toolkit for WinNonlin expands the capabilities of WinNonlin, enabling the use of WinNonlin for in vivo-in vitro correlations (IVIVC).  The Toolkit brings enhanced deconvolution methods, numerical convolution, new plotting capability, and the “IVIVC Wizard” to pharmacokineticists and formulators. Now you can use WinNonlin to speed formulation development, improve chances of success in bioequivalence studies, and much more.

IVIVC Toolkit can save you money. IVIVC can allow you to substitute fast, relatively inexpensive dissolution analysis for slow, expensive bioavailability or bioequivalence (BA/BE) studies.  The Product Quality Research Institute says the average NDA has 3-6 BA/BE studies.  The savings from avoided BA/BE testing can create a powerful ROI for your investment in IVIVC Toolkit. 

IVIVC Toolkit can save you time. Pharsight estimates that a typical BA/BE study requires a total of 3 months, end to end, to write the protocol, recruit patients, conduct bioanalytic work, and analyze the results. Saving even 1 or 2 BA/BE studies can knock months off time-to-market. 

Using Excel for IVIVC?  Most users of IVIVC Toolkit find they benefit from many features that Excel simply doesn't have: dialogue-guided wizards and tools to streamline the workflow, automatic estimation of UIR, and workflow support for a complete, 2-stage IVIVC to name just a few.

  

Pharsight offers software evaluation licenses to commercial organizations

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Features

Deconvolution

  • Wagner-Nelson
  • Loo-Riegelman
  • Numerical

Convolution

  • Run multiple inputs over multiple responses at once

Levy Plot

  • Assess time-scale of dissolution experiments

IVIVC Wizard

  • Easily manage data and workflow
  • Use custom correlation equations

Usability

Whether you are an experienced WinNonlin user looking to expand the program’s capabilities, or a new WinNonlin user interested primarily in IVIVC, you will find WinNonlin and the IVIVC Toolkit very easy to use.  The interface theme of analytical tools operating on a worksheet is familiar to most spreadsheet users.  In addition, the dialog-guided tools and wizards in WinNonlin and the IVIVC Toolkit help streamline complicated processes and keep the user from getting lost in the details.

Benefits

  • Speed development of new formulations
  • Incrementally leverage your existing investment in WinNonlin
  • Reduce bioequivalence test failures
  • Set optimal dissolution specs for Quality Assurance
  • Harness powerful IVIVC exploration and development capability
  • Visualize the in-vitro in-vivo relationship with new plotting features
  • Improve collaboration between Clinical Development and Formulation
  • Easily apply correlations to predict PK from new in vitro data