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Phoenix IVIVC Toolkit
The Gold Standard for Predicting Pharmacokinetic (PK) Parameters from In Vitro Dissolution Data in Drug Development and Formulations.
The Phoenix® IVIVC Toolkit™ creates and substantiates the Level A correlation as outlined in the FDA Guidance for Industry1 to correlate the in vitro dissolution profile of a dosage form with the in vivo pharmacokinetic (PK) profile. It can be used to predict the impact a change in formulation will have or predict the dissolution rate that is necessary to achieve a desired PK profile. The Level A IVIVC can support a biowaiver for changes in manufacturing site, raw material suppliers and minor changes in formulation.2
The IVIVC Toolkit provides a comprehensive workbench that can be used to demonstrate virtual bioequivalence:
- Deconvolution and Convolution modeling methods
- Flexibility to use built-in or custom correlation models
- IVIVC Wizard for data and workflow management
- Reusable workflow templates
- High quality outputs for creating reports and publication-quality tables, listings and figures
- Levy plots to assess time-scale of dissolution experiments
- Compliance, standardization and validation
Streamline the development process,
reduce costs and attain regulatory biowaivers
Save money: Inexpensive IVIVC studies can be used as a surrogate for expensive and time consuming bioavailability or bioequivalence (BA/BE) studies in animals or humans. The IVIVC Toolkit minimizes the number of BA/BE studies by quickly generating IVIVC results using workflows and high quality outputs.
Accelerate drug development: The IVIVC Toolkit provides predictive IVIVC methods that can help bring a drug to market faster by reducing the development effort from weeks to days.
Greater standardization and error-free results versus manual methods: Unlike Microsoft® Excel®, the IVIVC Toolkit provides many programmed features not found in Excel, including dialog-guided wizards and validated tools to streamline the workflow, automatic estimation of Unit Impulse Response (UIR), Levy Plots, workflow support for a complete two-stage IVIVC, and much more.
Facilitates collaboration: PK and IVIVC parameters can be seamlessly transferred within Phoenix. This provides a common collaboration platform for the formulation development and pharmacology teams.
Start using the Phoenix IVIVC Toolkit today
Contact us to find out how the comprehensive IVIVC Toolkit can be used to demonstrate virtual bioequivalence, streamline drug development and formulations, reduce costs and support the attainment of regulatory biowaivers.
1. US Department of Health and Human Services, Food and Drug Administration, and Center for Drug Evaluation and Research (CDER). Guidance for the Industry. Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations. September 1997.
2. S. Suarez-Sharpe, M. Li, J. Duan, H. Shah, and P. Sen. Regulatory Experience with In Vivo-In Vitro Correlations (IVIVC) in New Drug Applications. The AAPS Journal (2016). 18 (6):1379-1390.