title: The role of exploratory investigational new drugs for translating radiopharmaceuticals into first-in-human studies.
abstract: The Food and Drug Administration has provided a mechanism to reduce time and resources expended on new pharmaceuticals, including radiopharmaceuticals, in order to identify the most promising agents for further development. The exploratory investigational new drug guidance describes early phase 1 exploratory approaches involving microdoses of potential drug candidates that are consistent with regulatory requirements while maintaining the safety needed for human subjects, allowing sponsors to move ahead more quickly with the development of new agents.
authors.affiliation: Department of Radiology, School of Medicine, Washington University in St. Louis, St. Louis, Missouri schwarzs@mir.wustl.edu.
authors.forename: Sally W
authors.initials: SW
authors.lastname: Schwarz
authors.affiliation: Department of Radiology, School of Medicine, Washington University in St. Louis, St. Louis, Missouri.
authors.forename: Reiko
authors.initials: R
authors.lastname: Oyama
mesh_terms: D017321:Clinical Trials, Phase I as Topic; D004345:Drug Industry / Q000191:economics / Q000639:trends; D015507:Drugs, Investigational; D006801:Humans; D017387:Investigational New Drug Application; D061214:Patient Safety; D019275:Radiopharmaceuticals / Q000627:therapeutic use*; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational; D019275:Radiopharmaceuticals
keywords: 21 CFR Part 212; eIND; exploratory IND guidance; first-in-human RP; microdosing