TY - JOUR T1 - The Role of Exploratory Investigational New Drugs for Translating Radiopharmaceuticals into First-in-Human Studies JF - Journal of Nuclear Medicine JO - J Nucl Med SP - 497 LP - 500 DO - 10.2967/jnumed.114.146472 VL - 56 IS - 4 AU - Sally W. Schwarz AU - Reiko Oyama Y1 - 2015/04/01 UR - http://jnm.snmjournals.org/content/56/4/497.abstract N2 - 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. ER -