In Vitro – In Vivo Correlation IVIVC Equipment

Why IVIVC Matters in Drug Development

In vitro–in vivo correlation (IVIVC) helps teams predict how a formulation behaves in the body using lab-based dissolution data. When properly developed, these correlations can reduce the number of in vivo studies required, guide formulation optimization, and strengthen the scientific basis for regulatory decisions. For modified-release products, IVIVC offers meaningful insight into release mechanisms, bioavailability trends, and performance consistency across lots and scales.

What IVIVC Equipment Includes

IVIVC workflows rely on three pillars:

• Precision Dissolution Testing: Stable temperature, controlled hydrodynamics, repeatable sampling, and configurable media support method robustness.
• Automated Sampling and Analysis: Autosamplers with timed pulls, integration with UV/Vis or LC systems, and data integrity features to support audit needs.
• Advanced Modeling Software: Deconvolution, convolution, and correlation tools (Level A, B, C) to evaluate fit, sensitivity, and predictive utility across dose strengths and batches.

Key Benefits

• Speeds Formulation Decisions: Rapidly compare prototypes and support adjustments to polymers, granulation, or coating parameters.
• Supports Scale-Up and Tech Transfer: Evaluate whether process or equipment changes meaningfully impact in vivo performance.
• Enhances Regulatory Submissions: Present cohesive, statistically supported relationships between dissolution and pharmacokinetics.
• Reduces Development Risk: Identify sensitivity to critical material attributes and process parameters early.

Life Sciences Applications

• Immediate and Modified-Release Oral Solid Dose
• Complex Generics and Bioequivalence Strategies
• Lifecycle Management and Post-Approval Changes
• QbD and DoE Programs for Robust Methods

Buying Considerations

• Dissolution Vessel and Drive Accuracy: Look for tight tolerances and stable bath control.
• Sampling Flexibility: Consider cannula geometry, filtration options, and autosampler timing.
• Data Integrity: Evaluate electronic records controls, user management, and traceability features.
• Modeling Capabilities: Confirm support for Level A correlation and robust deconvolution algorithms.
• Method Transfer: Assess reporting and comparability tools to align sites and partners.

Best Practices

• Start with high-quality, discriminating dissolution methods.
• Use statistically sound design to explore formulation/process space.
• Validate model predictiveness with independent batches.
• Maintain strong data governance to support audits and submissions.

Ready to advance your IVIVC program? Contact our team to discuss configurations, software options, and method development support.