Comparison of Phase-0 Microdosing Operations with Traditional Phase-1 Approaches
Phase-0 microdosing operations have many similar features to traditional Phase-1 programs. However, Phase-0 approaches are usually shorter, smaller, quicker, and therefore cheaper to run. Phase-0 Microdosing operations are primarily defined by the sub-therapeutic exposures to the test drug. This means the exposure is safer than traditional approaches, but also that research participants cannot expect therapeutic benefit. This has ethical, methodological, and technological implications.