Integrating computational methods, IVIVC, and real-world evidence for bioequivalence assessment in transitional markets: A perspective

Current bioequivalence (BE) assessment methods for generic drugs face notable constraints - substantial costs, lengthy timelines, and narrow population representation. This perspective examines how integration of computational methods with In Vitro-In Vivo Correlation (IVIVC) and Real-World Evidence (RWE) might address these challenges, particularly for transitional regulatory environments. Markets enforcing BE requirements during marketing authorization renewals for products with years of clinical use but without formal BE studies, represent a unique case where this approach proves especially relevant. Rather than advocating replacement of traditional assessment, we suggest this tripartite framework as complementary methodology to potentially minimize unnecessary testing while maintaining scientific validity. Applications across Biopharmaceutics Classification System classes appear variable; implementation would logically follow a graduated pathway. We acknowledge current limitations while identifying specific research priorities to advance this approach.