Summary:
In vitro-in vivo correlation (IVIVC) is the establishment of a relationship between a biological property or a parameter derived from a biological property produced by a dosage form and a physicochemical property of the same dosage form. The most commonly used biological properties are one or more pharmacokinetic parameters, such as maximum plasma concentration Cmax) or area under the plasma concentration time curve (AUC), obtained following the administration of the dosage form. The most commonly used physicochemical property is dosage form’s in vitro dissolution behavior (e.g., percent of rug released under a given set of conditions). Use of a validated VIVC greatly improves the certainty with which predictions of in vivo results from in vitro release can be made. IVIVC levels can be grouped as level A, B, C and Multiple C. Level Acan beused to predict the in vivo time course from the in vitro data because it represents a point-to point relationship between the in vitro dissolution rate and the in vivo absorption rate of the dosage form. Level B and C correlations, however, are used to select the appropriate excipients, optimizing manufacturing processes, or quality control purposes and for characterizing the release patterns of immediate release (IR) and modified release products relative to the reference. The aim of the VIVC, especially if level Acorrelation has been provided, is to reduce the number of bioequivalence studies using these data or in some cases to waive them.