The Role of Exploratory Investigational New Drugs for Translating Radiopharmaceuticals into First-in-Human Studies

1. Sally W. Schwarz and 
2. Reiko Oyama

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Author Affiliations

1. Department of Radiology, School of Medicine, Washington University in St. Louis, St. Louis, Missouri

1. For correspondence or reprints contact: Sally W. Schwarz, Washington University in St Louis, School of Medicine, Department of Radiology, 510 South Kingshighway, St. Louis, MO 63110. E-mail: schwarzs@mir.wustl.edu

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.

Keywords

• exploratory IND guidance
 
• eIND
 
• microdosing
 
• 21 CFR Part 212
• first-in-human RP

Footnotes

• Published online Mar. 12, 2015.

• © 2015 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Link original: http://jnm.snmjournals.org/content/56/4/497