Phase 0, including microdosing approaches: Applying the Three Rs and increasing the efficiency of human drug development
Tal Burt, Le Thuy Vuong, Elizabeth Baker, Graeme C. Young, A. Daniel McCartt, Mats Bergstrom, Yuichi Sugiyama and Robert Combes Phase 0 approaches, including microdosing, involve the use of sub-therapeutic exposures to the tested drugs, thus enabling safer, more-relevant, quicker and cheaper first-in-human (FIH) testing. These approaches also have considerable potential to limit the use of animals in