Development of an Integrated Mathematical Model for Comparative Characterization of Complex Molecules (U01)

The goal of this project is to develop a mathematical algorithm or model to integrate in vitro chemical and biological characterization data to determine the degree of sufficiency of in vitro chemical and biological characterization assays, with respect to demonstrating similarity or sameness of the follow-on or generic version of macromolecules or complex drug substances to their reference products. The integrated mathematical and analytical approach developed in this project is expected to provide a "coherent picture" of molecular structure for complex macromolecules or drug substances, and thus may help to determine the extent to which the preclinical and/or clinical studies will be needed for generic or follow-on version of drug products containing these complex molecules.