Experience on Utilization of Novel Modeling & Simulation Approaches in Generic Product Development

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Modeling and simulation approaches such as Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutics Modeling (PBBM) are gaining importance due to their impact to transform drug development paradigm. Development of such modeling approaches include integration of drug substance, drug product and physiological aspects followed by validation against clinical data. In this manuscript, we have highlighted utility of PBPK and PBBM in generic product development using case examples. An application where PBBM was utilized to obtain biowaivers and dissolution safe space was portrayed. Utility of such modeling approaches in obtaining fed bioequivalence studies was discussed with case example. Impact of gender evaluation on bioequivalence study outcome using PBPK approach was highlighted with a case example. Evaluation of safety aspects of extended release formulation with help of modeling approach was discussed with practical example. In the last case study, understanding the impact of critical bioavailability attributes with help of PBBM was indicated. Further, future direction in terms of sharing best practices across academia, industry and regulatory was highlighted. Overall, this manuscript summarizes experience on utilization of modeling and simulation approaches in generic product development with an aim to have more affordable and quality medicines to the patients.