The role of exploratory investigational new drugs for translating radiopharmaceuticals into first-in-human studies

Sally W. Schwarz, Reiko Oyama

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

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.

Original languageEnglish
Pages (from-to)497-500
Number of pages4
JournalJournal of Nuclear Medicine
Volume56
Issue number4
DOIs
StatePublished - Apr 1 2015

Keywords

  • 21 CFRPart 212
  • EIND
  • Exploratory IND guidance
  • First-in-human RP
  • Microdosing

Fingerprint

Dive into the research topics of 'The role of exploratory investigational new drugs for translating radiopharmaceuticals into first-in-human studies'. Together they form a unique fingerprint.

Cite this