Clinical Pharmacology – Chemical
This session is intended to share with attendees an overview of the generic drug approval process, with select emphasis on bioequivalence determination. Attendees will hear an overview of traditional approaches to bioequivalence for generic drug applications, e.g., PK/PD, followed by discussion of the use of clinical endpoint studies and its limitations. Newer approaches to characterize critical performance elements leads to more efficient generic drug development and regulatory decision making especially for complex generic drug products. Lastly, the clinical pharmacology tools of quantitative methods and modeling simulation will be discussed as ways to integrate and bridge existing knowledge to streamline product development and regulatory decisions.