Phoenix® IVIVC Toolkit™ Your clear choice for obtaining biowaivers
When pharmaceutical companies modify drug formulations or change manufacturing facilities, they face significant regulatory challenges that are both expensive and lengthy. To help expedite these approval processes, regulatory authorities frequently recognize In Vitro–In Vivo Correlation (IVIVC) studies as valid supporting data for biowaiver requests. This approach is particularly valuable for SUPAC (Scale-Up and Post-Approval Changes) modifications, enabling companies to bypass in-vivo bioequivalence testing and helping scientists improve BE study successfully with fewer assumptions and better correlation between in vivo and dissolution profiles.
akthealth
Jun 11, 2025 05:47
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The Phoenix IVIVC Toolkit transforms and standardizes IVIVC methodologies by delivering an integrated platform of tools that enhance efficiency and reliability. Through innovative features including guided dialog wizards, numerical deconvolution capabilities, and customizable correlation modeling, this software delivers exceptional support across Level A, B, and C IVIVC investigations.
Key Features of the Phoenix® IVIVC Toolkit™
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Guided Workflows & Ease of Use
The toolkit includes a wizard-guided interface that walks users through the creation of Level A IVIVC models. Dialog-guided tools and built-in examples ensure a quick learning curve, helping users become proficient in a short amount of time. -
Modeling & Analysis Tools
Phoenix supports Level A correlation modeling directly, while Levels B and C can be completed using WinNonlin. Users can choose from built-in correlation models or develop custom models tailored to their specific study requirements. It also features built-in models for more accurate interpolation of dissolution data. -
Deconvolution & Estimation
The software employs numerical deconvolution methods known for their accuracy and stability, making them less sensitive to variations in study design. Automatic estimation of Unit Impulse Response and the generation of Levy Plots provide users with powerful tools for detailed analysis. -
Collaboration & Traceability
Integrated within the Phoenix Platform, the toolkit enables seamless collaboration among team members. Each workbook includes comprehensive history and settings logs, making it easy to track changes and ensure audit readiness.
Discover how the Phoenix IVIVC Toolkit can revolutionize your IVIVC studies. Connect with our experts to see demonstrations, explore real-world case studies, and learn how Phoenix can accelerate your pathway from formulation to patient. Contact AKT Health at info@akthealth.com to learn more.
