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Phoenix® IVIVC Toolkit™

Your clear choice for obtaining biowaivers

Streamline bioequivalence studies with the Phoenix IVIVC software

Changes to drug formulations or manufacturing sites can be costly and time-consuming. Regulatory agencies accept in-vitro in-vivo correlation (IVIVC) studies to support biowaivers for SUPAC changes, waive in-vivo bioequivalence for lower strengths, and address other BE requirements.

Certara’s Phoenix IVIVC Toolkit is a leading IVIVC software that provides advanced tools for IVIVC studies, helping scientists improve BE study success with fewer assumptions and better correlation between in vivo and dissolution profiles.

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Minimize the number of bioavailability or bioequivalence studies

Standardize workflows with validated tools and automated features

Ensure adherence to regulatory guidelines

Advanced IVIVC software for simplified workflows and improved outcomes

The Phoenix IVIVC Toolkit simplifies and standardizes IVIVC workflows, offering a comprehensive suite of tools to streamline processes and improve outcomes. With features like dialog-guided wizards, numerical deconvolution, and custom correlation models, this software provides unparalleled support for Level A, B, and C IVIVC studies.

Built-in models for dissolution data interpolation.

Automatic estimation of Unit Impulse Response and Levy Plots.

Seamless collaboration through the Phoenix Platform.

What makes Phoenix IVIVC a clear choice for PK scientists

Navigation

A 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.

Fit-for-purpose tools for confidence

Go beyond Microsoft Excel with Levy Plots, automatic estimation of Unit Impulse Response, and support for complete two-stage IVIVC.

Keep track

Leverage each workbook’s History and Settings information for audits.

Quick learning curve

Includes dialog-guided tools and examples to get you up to speed quickly.

How formulation scientists benefit from Phoenix IVIVC software

Accelerate drug development

Reduce development timelines from weeks to days with predictive IVIVC methods, enabling faster regulatory filings and market entry.

Streamline workflows

Leverage dialog-guided wizards and validated tools to simplify IVIVC processes and minimize errors.

Enhance collaboration

Easily transfer pharmacokinetic and IVIVC parameters within the Phoenix Platform for seamless team collaboration.

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Phoenix Hosted delivers faster compute, outsourced validation, and flexibility of access across Mac and PC operating systems.

Reduce the time & complexity to prepare and analyze pharmacokinetic (PK) datasets.

Included with Phoenix Hosted, Certara’s Integral equips PK scientists with an API-enabled data repository supporting both GXP and non-GxP studies.

Prevent rejections in the late stages of drug development & maximize chances of success with Certara's Trial Simulator.

Modeling and Simulation - PK/PD

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