RT Journal Article
SR Electronic
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
FD Society of Nuclear Medicine
SP 497
OP 500
DO 10.2967/jnumed.114.146472
VO 56
IS 4
A1 Sally W. Schwarz
A1 Reiko Oyama
YR 2015
UL http://jnm.snmjournals.org/content/56/4/497.abstract
AB 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.