Model-based Drug Development for Generic Products

As a generic drug manufacturer, the goal of your product development program is to demonstrate bioequivalence of your product to the branded product. Often a straight-forward trial and error process based on the experience of the formulation team has been successful. As innovators plan ahead to protect their product lines, however, they have made this task more difficult. Whether by utilizing unique and patented delivery technology, or by modifying the dissolution and absorption characteristics of the active ingredient through novel formulation, the innovator may confound the efforts of generic formulators.

These challenges may be overcome by a Model Based Drug Development approach. The Food and Drug Administrations (FDA) Center for Drug Evaluation and Research (CDER) has identified in vitro-in vivo correlation (IVIVC) as an opportunity in its Critical Path Initiative for Generic Drugs, where it states:

The development of an IVIVC model for use in steering formulation development decisions and selecting candidate formulations for bioequivalence trials is within the reach of most generics companies. The approach and technical details involved, however, may be unfamiliar to those outside of pharmaceutical development circles. But addressing the knowledge gap and providing appropriate tools would go a long way to speeding generic development and increasing success rates in bioequivalence trials.