In Vitro–In Vivo Correlation on Parenteral Dosage Forms

Abstract

In vitro and in vivo correlation (IVIVC) for drug products, especially for solid oral dosage forms, has been developed to predict product bioavailability from in vitro dissolution. Biological properties such as Cmax, or AUC have been used to correlate with in vitro dissolution behavior such as percent drug release in order to establish IVIVC. IVIVC can be used to set product dissolution specifications; and as a surrogate for in vivo bioequivalence in the case of any changes with respect to formulation, process, or manufacturing site.