In Vitro Product Performance Testing of Oral Drug Products: View of the USP Expert Panel

This is the last in a series of Stimuli articles developed by the USP Expert Panel New Advancements in Product Performance Testing charged with reviewing and proposing new approaches for drug performance testing in the US Pharmacopeia. The USP Expert Panel created working groups that focused on five major routes of administration, continuous manufacturing, and nanomaterials. The article reports the results of the working group that studied the performance tests for orally administered drug products. The goal of this article is to highlight current knowledge gaps and potential challenges associated with performance tests for certain orally administered drug products, and to stimulate public input on current practices and new advances for in vitro testing. The input received may inform the development or revision of USP general chapters.