Phase 0/microdosing approaches: time for mainstream application in drug development?
Nature Reviews Drug Discovery September 8, 2020 Tal Burt, Graeme Young, Wooin Lee et al. 101 citations
Phase 0 approaches - which include microdosing - evaluate subtherapeutic exposures of new drugs in first-in-human studies known as exploratory clinical trials. Recent progress extends phase 0 benefits beyond assessment of pharmacokinetics to include understanding of mechanism of action and pharmacodynamics. Phase 0 approaches have the potential to improve preclinical candidate selection and...