Assistant Professor University of Florida, Florida, United States
Disclosure(s):
Brian Cicali, Phd, MS: No financial relationships to disclose
Combined oral contraceptives (COCs) are among the most widely used contraceptive methods globally. Drug-drug interactions (DDIs) with co-administered medications can compromise their efficacy and safety, creating a critical regulatory concern. The newly developed DDI Clinical Trial Simulator, funded by the Bill & Melinda Gates Foundation, leverages OSP Suite models to predict the impact of DDIs on COC pharmacokinetics and clinical outcomes. This tool translates in vitro findings into expected clinical responses, providing insights into both efficacy (Pearl Index) and safety (breakthrough bleeding). This simulator is implemented as an RShiny app built on top of esqlabsR and ospsuiteR, enabling an intuitive, user-friendly interface for trial design and scenario analysis. This presentation will showcase the simulator's development, validation, and its potential to inform DDI trial design for regulatory submissions.
