IVIVC Toolkit

IVIVC Toolkit for Phoenix WinNonlin

The IVIVC Toolkit for Phoenix® WinNonlin® is a software tool that uses the Level A correlation outlined in a FDA guidance to correlate the in vitro dissolution profile of a dosage form with the in vivo pharmacokinetic (PK) profile. It can be used to predict the impact a change in formulation will have or predict the dissolution rate that is necessary to achieve a desired PK profile. The Level A IVIVC can support a bio waver for changes in manufacturing site, raw material suppliers and minor changes in formulation. Pharmacokineticists and formulators can use the IVIVC Toolkit for Phoenix WinNonlin to:

  • Support deconvolution and convolution methods
  • Produce Levy plots
  • Manage data and workflows using the “IVIVC Wizard”

Benefits

  • Saves money: IVIVC bio waiver can be used to substitute expensive bioavailability or bioequivalence (BA/BE) studies with relatively inexpensive dissolution analysis.
  • Brings drugs to market faster: A typical BA/BE study requires a total of three months. Thus, saving even one or two BA/BE studies can knock months off time-to-market for a drug.
  • Contains more features than Microsoft® Excel®: Unlike Excel, the IVIVC Toolkit features dialogue-guided wizards and tools to streamline the workflow, automatic estimation of the UIR, and workflow support for a complete two-stage IVIVC.
  • Facilitates collaboration: PK and IVIVC parameters can be seamlessly transferred within Phoenix. This provides a common collaboration platform for the formulation development and pharmacology teams.

Functionality

Modeling capabilities

  • Deconvolution
    • Wagner-Nelson
    • Loo-Riegelman
    • Numerical
  • Convolution
    • Run multiple inputs over multiple responses at once
  • IVIVC Wizard
    • Easily manage data and workflow
    • Use custom correlation equations

Graphics capabilities

  • Assess the time-scale of dissolution experiments in Levy plots
  • Summarize deconvolution and correlation results in plots

Contact us to learn more about how the IVIVC Toolkit for Phoenix WinNonlin can can support waivers for BE studies to save your organization time and money.

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