ABSTRACT

The process of establishing a Level A in vitro–in vivo correlation (IVIVC) consists of a number of steps. The literature on Level an IVIVC modeling and data analysis is quite extensive, and a wide variety of models and data analytic approaches have been reported. It can be difficult to compare many of these models and methods to see what they have in common and how they differ. The first step in the process of developing an IVIVC model involves the construction of a model describing the functional relationships of interest. This model is deterministic in that it does not take into account the random element of the data used to establish the IVIVC. IVIVC modeling aims to use information about in vitro dissolution of a solid dosage form to predict its in vivo performance. In order to achieve this, a relationship is constructed between in vitro and in vivo dissolution of drug from the dosage form.