Quantitative Modeling & Simulation Case Studies
PopPK/PD Model to Support Phase II Waiver
Breaking the conventional sequential Phase I→II→III new drug development pathway, robust population PK/PD models are built on pooled Phase I clinical pharmacology datasets. Model-derived exposure-response relationships and efficacy/safety biomarkers provide solid regulatory evidence to apply for Phase II trial waivers, enabling seamless direct progression to Phase III pivotal trials and drastically cutting overall clinical development timelines and R&D expenditure.
