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Certara offers predictive science and informatics solutions that enable cross-disciplinary and translational approaches to drug development.

PK/PD Modeling and Simulation

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IVIVC ToolkitTM for Phoenix® WinNonlin®

The best guided tool for In-Vitro-In-Vivo Correlation (IVIVC) analyses

The IVIVC Toolkit for Phoenix WinNonlin expands the capabilities of Phoenix WinNonlin, enabling the use of Phoenix WinNonlin for in vitro-in vivo 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 Phoenix 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. Certara 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.

Key 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

Key Benefits

  • Easy to use, intuitive, and guided.
  • Availability in the Phoenix platform provides seamless integration with other Phoenix tools, so inputs and outputs from IVIVC can be easily linked to other analysis tools within Phoenix.
  • Speed development of new formulations
  • Incrementally leverage your existing investment in Phoenix 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
  • Whether you are an experienced Phoenix WinNonlin user looking to expand the program’s capabilities, or a new Phoenix WinNonlin user interested primarily in IVIVC, you will find Phoenix WinNonlin and the IVIVC Toolkit for Phoenix WinNonlin 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.

System Requirements

IVIVC Toolkit for Phoenix WinNonlin is supported for both 32-bit and 64-bit versions of Windows XP SP3, Windows 2003, Windows 7 SP1, Windows 2008 Server R2.

Minimum Hardware Requirements:

  • Processor:  Intel Core 2 Duo 2.0 Ghz, or a CPU of EQUIVALENT processing power

  • RAM:  2 gigabytes RAM

  • Hard drive space:  300 megabytes free

Click here for detailed system requirements, including international language support.