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INDs for PET molecular imaging probes-approach by an academic institution
Sherly Mosessian1, Sandra M Duarte-Vogel, David B Stout
1Department of Molecular and Medical Pharmacology, David Geffen School of Medicine at University of California Los Angeles, 650 Charles E. Young Dr. South, CHS 23-148, Los Angeles, CA, 90095, USA, smosessian@mednet.ucla.edu.
Abstract:
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.
