In Vitro-In Vivo Correlation (IVIVC) is a predictive mathematical tool that describes the relationship between the in vitro property of a drug dosage form and an in vivo pharmacokinetic (PK) response.
The data, calculations and profile plot is presented below. Table1: Data. Table 2: Calculations. Figure 1: Dissolution profile plot. Observations: All the time points until 90 minutes were used in the f2 calculation since more than 85% dissolution mean was seen for both the formulations by 60 minutes. Alimony calculator free download - Divorce / Alimony Calculator, Mass Alimony, Free Calculator, and many more programs.
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Developing IVIVCs for solid dosage forms, especially for extended release formulations, is encouraged by the US FDA1, EMA, PMDA and other regulatory agencies. It is considered an important tool for supporting biowaivers and has become a surrogate for in vivo human bioequivalence (BE) studies.2
The Phoenix® IVIVC Toolkit™ from Certara provides enhanced tools for in vitro-in vivo correlation studies used by formulation and pharmaceutical scientists to improve the success of BE studies. The IVIVC Toolkit approach requires fewer assumptions, as compared to other methods, and helps you define the correlation observed from real in vivo profiles as compared to the dissolution profiles.
By using the IVIVC Toolkit, you can accelerate the analysis and documentation of IVIVC to support regulatory filings.Why choose the WinNonlin IVIVC Toolkit?
Save money: Minimize the number of bioavailability or bioequivalence (BA/BE) studies by quickly generating IVIVC results using workflows and high quality outputs
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Accelerate drug development: Bring a drug to market faster by reducing the development effort from weeks to days with predictive IVIVC methods
Standardize and reduce errors: The WinNonlin IVIVC Toolkit provides features not found in Microsoft® Excel®
Facilitates collaboration: Easily transfer PK and IVIVC parameters within the Phoenix Platform, a collaboration environment for your teamsContact us