Accelerate analysis for regulatory filings

In Vitro-In Vivo Correlation (IVIVC) is a predictive mathematical tool that describes the relationship between the in vitro property of a drug dosage form and an in vivo pharmacokinetic (PK) response.

Developing IVIVCs for solid dosage forms, especially for extended release formulations, is encouraged by the US FDA1, EMA, PMDA and other regulatory agencies. It is considered an important tool for supporting biowaivers and has become a surrogate for in vivo human bioequivalence (BE) studies.2

The Phoenix® IVIVC Toolkit™ from Certara provides enhanced tools for in vitro-in vivo correlation studies used by formulation and pharmaceutical scientists to improve the success of BE studies. The IVIVC Toolkit approach requires fewer assumptions, as compared to other methods, and helps you define the correlation observed from real in vivo profiles as compared to the dissolution profiles.

By using the IVIVC Toolkit, you can accelerate the analysis and documentation of IVIVC to support regulatory filings.

Why choose the WinNonlin IVIVC Toolkit?

Save money: Minimize the number of bioavailability or bioequivalence (BA/BE) studies by quickly generating IVIVC results using workflows and high quality outputs

Accelerate drug development:  Bring a drug to market faster by reducing the development effort from weeks to days with predictive IVIVC methods

Standardize and reduce errors: The WinNonlin IVIVC Toolkit provides features not found in Microsoft® Excel®

  • Wizards and validated tools to streamline your workflow
  • Automatic estimation of Unit Impulse Response
  • Levy Plots
  • Support for a complete two-stage IVIVC

Facilitates collaboration:  Easily transfer PK and IVIVC parameters within the Phoenix Platform, a collaboration environment for your teams

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Built-in support to save you time
  • Navigation—Wizard provides an intuitive interface that walks you through how to create a Level A IVIVC
  • Deconvolution Methods—Numerical deconvolution is known for its stability and accuracy and is generally less susceptible to study design variations
  • Fitting the Correlation—Provides Level A correlation; Levels B and C can be done using WinNonlin
  • Custom Models—Use built-in correlations or develop a custom correlation model
  • Dissolution Modeling—Built-in models better interpolate dissolution data
  • Quick Learning Curve—Includes dialog-guided tools and examples to get you up to speed quickly
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Standardize and simplify your IVIVC workflow
  • Streamline the IVIVC workflow processes with dialog-guided wizards and tools
  • Get automatic estimation of Unit Impulse Response
  • Get workflow support for a complete, 2-stage IVIVC with the ability to extend to a 1-stage IVIVC using the Phoenix model engine
  • Levy Plots to assess time-scale of dissolution experiments
  • Access a wide range of programmed and validated tools, including NCA, interpolation, deconvolution, convolution, PK modeling, model selection criteria, data merge and join
  • Leverage History and Settings information for each workbook for audits
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