Use of imaging technologies to support complex generic drug development.

SIGNIFICANCE: Complex drug products remain costly and inaccessible to many patients. The use of modern imaging technologies offers transformative tools to address generic drug research challenges, allowing for improved patient access to safe and effective generic medicines. AIM: This review summarizes imaging research related to a wide range of complex drug products across five coordinated initiatives: high-order characterization of the arrangement of matter in complex products; elucidation of the relationship between the structural features and the functional performance of these dosage forms; establishment of noninvasive approaches to characterize and compare the rate and extent of drug bioavailability from these dosage forms; development of reliable artificial intelligence and machine learning approaches to analyze imaging data; and provision of mechanistic insights to inform the construction of computational models. RESULTS AND CONCLUSIONS: The technologies summarized in this work enabled non-destructive structural characterization of complex drug products, establishment of structure-performance relationships, and direct measurement of drug availability at local sites of action. Furthermore, currently available technologies used for imaging complex drug products continue to support the establishment of scientifically rigorous, efficient bioequivalence pathways for complex generic products, reducing reliance on costly comparative clinical endpoint studies.