ABSTRACT
A number of Food and Drug Administration (FDA) guidances discuss the development and role of in vitro-in vivo correlation (IVIVC) in oral solid dosage forms (1-4). One of these guidances, the FDA IVIVC Guidance (1), has defined IVIVC as
Four types of IVIVC approaches (i.e., Level A, Level B, Level C, Multiple Level C) are defined within this guidance. A Level A correlation is ‘‘a predictive mathematical model for the relationship between the entire in vitro dissolution release time course and the entire in vivo response time course.’’ A Level B correlation is ‘‘a predictive mathematical model for the relationship between summary parameters that characterize the in vitro and in vivo time courses, e.g., models that relate mean in vitro dissolution time to the mean in vivo dissolution time.’’ A Level C correlation is ‘‘a predictive mathematical model for the relationship between the amount dissolved in vitro at a particular time (or the time required for in vitro dissolution of a fixed percent of the dose) and a summary parameter that characterizes the in vivo time course (e.g., Cmax or AUC).’’ A Multiple Level C correlation is ‘‘a Level C correlation at several time points in the dissolution profile.’’ Although each type of IVIVC may have its place in the product development process, the Level A correlation is accepted as the most informative IVIVC for oral drug delivery systems.
