![]() The IVIVC Toolkit minimizes the number of BA/BE studies by quickly generating IVIVC results using workflows and high quality outputs.Īccelerate 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. 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. Reduce costs and attain regulatory biowaivers Compliance, standardization and validation.Levy plots to assess time-scale of dissolution experiments.High quality outputs for creating reports and publication-quality tables, listings and figures.IVIVC Wizard for data and workflow management.Flexibility to use built-in or custom correlation models.Deconvolution and Convolution modeling methods.The IVIVC Toolkit provides a comprehensive workbench that can be used to demonstrate virtual bioequivalence: The Level A IVIVC can support a biowaiver for changes in manufacturing site, raw material suppliers and minor changes in formulation. 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 Phoenix ® IVIVC Toolkit ™ creates and substantiates the Level A correlation as outlined in the FDA Guidance for Industry 1 to correlate the in vitro dissolution profile of a dosage form with the in vivo pharmacokinetic (PK) profile. The Gold Standard for Predicting Pharmacokinetic (PK) Parameters from In Vitro Dissolution Data in Drug Development and Formulations. The creators of this software claim that the product you meet can meet all your needs. This software is referred to as a leading tool in the modeling and simulation industry. Phoenix is the name of the Certara Group’s engineering and product engineering software in the field of simulation and modeling of PK / PD. ![]()
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