In Vitro and In Vivo Correlation Plus Module

An in vitro in vivo correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in vitro property of a dosage form and a relevant in vivo response. When performing IVIVC for formulation development, the in vitro property is primarily dissolution or drug release and the in vivo response is primarily the concentration of the drug in plasma (the plasma-concentration time data) or the amount/rate of drug absorbed. Because IVIVC expresses the relationship between drug release in a dissolution apparatus and how that translates to the amount of drug that enters the bloodstream following administration, IVIVC is important for many different scenarios, but it is especially important for extended release oral formulations.

This section details a Level A IVIVC, which is a specific category of IVIVC that you can carry out in the optional In Vitro and In Vivo Correlation Plus (IVIVC™) module. The module extends the capabilities of GastroPlus® by providing a way to develop a correlation between either in vitro release and in vivo release or in vitro release and absolute bioavailability. You can then use the formed correlation to predict plasma concentration- time profiles for reasonably similar formulations with different in vitro release rates.

This section covers the following topics:

• IVIVC Benefits and Categories

• Level A IVIVC Required Inputs and Established Steps

• Level A IVIVC Deconvolution

• Level A IVIVC Validation

For details about the internal standards that were used to define the equations in this section, see Equation Standards.