Quantitative Modeling & Simulation Case Studies
PBPK-DDI Model for DDI Clinical Study Exemption
Using in vitro metabolism data and clinical PK profiles of strong CYP enzyme inhibitors/inducers, full PBPK-DDI simulation quantitatively predicts interaction risks for moderate and weak enzyme modulators. Validated modeling outputs can be submitted to regulatory authorities to apply for exemption from dedicated human clinical DDI trials, cutting development cost and shortening clinical research cycles for new molecular entities.
