Accelerating Drug Development: How Certara’s Phoenix® IVIVC Toolkit Transforms Bioequivalence Studies

In modern pharmaceutical development, every day counts, and regulatory delays can result in significant financial losses.
When drug manufacturers modify formulations or manufacturing sites, traditional bioavailability/bioequivalence (BA/BE) studies can be time-consuming and costly.

But what if those studies could be simplified, standardized, and completed in days instead of weeks?

Meet the Phoenix® IVIVC Toolkit™ from Certara, a breakthrough in in vitro–in vivo correlation (IVIVC) modeling that empowers formulation scientists to make faster, data-driven, and regulator-ready decisions.

Why IVIVC Matters: The Science Regulators Trust

Global regulatory agencies increasingly recognize the value of scientifically robust IVIVC studies. A well-established IVIVC creates a bridge between laboratory dissolution testing and real-world in vivo drug performance, enabling predictive, ethical, and cost-effective development.

When properly implemented, IVIVC studies can support:

• Biowaivers for formulation changes (SUPAC)
• Strength-based waivers that eliminate redundant in-vivo BE studies
• Bioequivalence waivers in specific regulatory scenarios

The Phoenix IVIVC Toolkit makes these regulatory pathways more accessible, transparent, and efficient.

From Weeks to Days: The Speed Revolution

Traditional IVIVC development often takes weeks. Phoenix reduces this to days.
 Its advanced modeling algorithms use fewer assumptions and more precise data integration, delivering faster, more reliable correlations between in-vitro dissolution and in-vivo pharmacokinetic performance.

This speed doesn’t just accelerate submission timelines; it frees R&D teams to focus on what matters most: innovation and patient outcomes.

Standardization Meets Innovation

Historically, IVIVC analysis required specialized expertise and custom-built workflows.
 Phoenix changes that by offering standardized, reproducible, and auditable processes, ensuring consistency across teams and studies.

That standardization means:

• Fewer manual steps
• Reduced analytical variability
• Enhanced reproducibility for regulatory submissions
  
   

Key Advantages That Define Phoenix IVIVC Toolkit

1. Intelligent Workflow Management

Guided dialog wizards lead users through every step of IVIVC development.
 Whether you’re a formulation scientist or a clinical pharmacologist, Phoenix ensures each critical analysis is performed correctly and consistently.

2. Advanced Technical Capabilities

Under the hood, the IVIVC Toolkit delivers robust analytical power:

• Automatic Unit Impulse Response (UIR) estimation
• Support for 1-stage and 2-stage IVIVC workflows
• Levy plots for dissolution time-scale visualization
• Integrated NCA, interpolation, deconvolution/convolution, PK modeling, and AIC
• Custom model support for specialized research designs
   

3. Streamlined Data Management

Seamless integration with Phoenix Workbench ensures traceability and scalability.
 All datasets, analyses, and reports are stored in a single project workspace, maintaining compliance with data integrity standards.

Users benefit from:

• Reusable templates for consistent project setup
• Automated generation of regulator-ready tables, listings, and figures
• Built-in traceability and audit history for compliance confidence
   

4. Compliance Built-In

Phoenix is designed to align with GxP principles, providing:

• Full history tracking and audit trails
• A verification tab for monitoring execution status
• Automated error detection for quality assurance
   

5. Technical Innovation That Enhances Accuracy

Unlike traditional tools, Phoenix uses numerical deconvolution for superior stability and precision.
 It also supports custom model development, accurate dissolution interpolation, and advanced error checking, ensuring robust, high-quality correlations every time.

The Future of Formulation Science

As the pharmaceutical landscape evolves, tools like the Phoenix IVIVC Toolkit are redefining efficiency, reproducibility, and scientific precision.

For formulation scientists, regulatory strategists, and R&D leaders, Phoenix provides a proven pathway to:

• Reduce development costs
• Accelerate regulatory approvals
• Enable predictive, patient-centered drug design

In an industry where precision and compliance define success, the Phoenix IVIVC Toolkit delivers both, empowering teams to go from formulation to approval faster and smarter.

Discover how the Phoenix IVIVC Toolkit can accelerate your drug development pipeline. Contact AKT Health at info@akthealth.com to explore live demos, real-world case studies, and implementation strategies.