Human Microdosing/Phase 0 Studies to Accelerate Drug Development
Human-based Systems for Translational Research December 9, 2014 R. Colin Garner
Microdosing Phase 0 studies provide early information about a drug's pharmacokinetics and limited pharmacodynamics before expensive Phase I trials. Developed in the 2000s, this method helps select drug candidates and uses ultrasensitive accelerator mass spectrometry. The chapter reviews the scientific, regulatory, ethical, and commercial aspects of microdosing, arguing that because the best model for humans is human, microdose studies should replace early in vitro and preclinical work as more relevant and predictive of a drug's ADME at therapeutic doses, offering a new paradigm for early drug development.