Whether considering next steps following lead candidate selection, formulation optimization during Phase 1, 2, or 3, the likely impact of proposed post-marketing changes in product formulation or manufacture, or attempting to generate generic versions of an approved marketed drug product, an understanding of the critical factors influencing drug product absorption is essential . Such information also helps determine the method to be used for testing product in vitro drug release and the associated criteria for ensuring consistent batch-to-batch product performance.…