Virtual Theranostic Trials: New Approach Methodologies (NAMs) and Precision Radiopharmaceutical Therapies

Abstract

Radiopharmaceutical therapies are expanding rapidly, but clinical evidence generation is limited by operational constraints and biological heterogeneity in radiopharmaceutical delivery and radiation risk. Virtual theranostic trials can run as companion trials, linking quantitative imaging to patient-specific models to generate evidence for personalized injections and scheduling, accelerate development, and broaden access.