Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development
Clinical and Translational Science February 26, 2016 Tal Burt, K Yoshida, Graham Lappin et al. 91 citations
Increasing costs of drug development and ethical concerns about the risks of exposing humans and animals to novel chemical entities favor limited exposure clinical trials such as microdosing and other phase 0 trials. An increasing body of research supports the validity of extrapolation from the limited drug exposure of phase 0 approaches to the full, therapeutic exposure. An increasing number...