Phase-0 Microdosing Literature: Published Studies, Regulations, News, and Reviews
The Phase-0 Microdosing Network and literature cut across multiple disciplines, stakeholders, and therapeutic areas. It is one of the few multi-professional congregations in an otherwise highly fragmented and super-specialized drug development space. Please check our 'Perspectives' piece in Nature Reviews Drug Discovery: https://rdcu.be/b61rf.
The following is a Phase-0 Microdosing literature list in reverse order by year of publication. The list includes research studies into methodologies and applications, regulations, news, and reviews. The list does not include Phase-0 including microdosing studies whose aim is exclusively to validate an assay. Also, the list does not include approaches who are meant to be used with therapeutic-level doses (such as microtracer studies). The list is likely an under-estimate of the Phase-0 Microdosing literature since not all studies that meet the definition of these approaches use the relevant terms in the publications, most importantly in the title, abstract, and keywords. In addition, the list is likely an underestimate of human studies using these approaches since at this stage of clinical development it is not required to report them in the public domain. Please contact us if you are aware of a publication that is not included.