Sid Bhoopathy

For more than a decade, simple bench-top experiments have been successfully employed to replace clinical bioequivalence according to the Biopharmaceutics Classification System (BCS) for immediate release solid oral dosage forms. However, as drug products continue to increase in complexity, there has been a growing initiative to enhance evaluation by introducing the concepts of quality target product profile (QTPP) and quality by design (QbD). By complementing the traditional paradigm of ‘equivalence by testing’, the current framework encourages the use of appropriate surrogates to target ‘pharmaceutical equivalence by design’. integrated and dynamic experimental approach, incorporating in vitro, in situ, ex vivo, and in vivo non clinical models can be used to evaluate alternate drug delivery routes, compare and optimize formulations (e.g. IVRT), understand the impact of excipient and polymorph substitutions, minimize DoE runs, and guide critical investment decisions. We will explore a rational and multi-pronged approach which relies on validated non-clinical models to bypass clinical studies and/or enhance QbD.