INDs for PET molecular imaging probes-approach by an academic institution

Mol Imaging Biol. 2014 Aug;16(4):441-8. doi: 10.1007/s11307-014-0735-2.


We have developed an efficient, streamlined, cost-effective approach to obtain Investigational New Drug (IND) approvals from the Food and Drug Administration (FDA) for positron emission tomography (PET) imaging probes (while the FDA uses the terminology PET drugs, we are using "PET imaging probes," "PET probes," or "probes" as the descriptive terms). The required application and supporting data for the INDs were collected in a collaborative effort involving appropriate scientific disciplines. This path to INDs was successfully used to translate three [(18) F]fluoro-arabinofuranosylcytosine (FAC) analog PET probes to phase 1 clinical trials. In doing this, a mechanism has been established to fulfill the FDA regulatory requirements for translating promising PET imaging probes from preclinical research into human clinical trials in an efficient and cost-effective manner.

MeSH terms

  • Academies and Institutes*
  • Animals
  • Cytarabine
  • Drug Approval
  • Drugs, Investigational*
  • Female
  • Humans
  • Male
  • Molecular Imaging* / economics
  • Molecular Probes* / economics
  • Positron-Emission Tomography* / economics
  • Rats, Sprague-Dawley
  • United States
  • United States Food and Drug Administration


  • Drugs, Investigational
  • Molecular Probes
  • Cytarabine