title: INDs for PET molecular imaging probes-approach by an academic institution.
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.
authors.affiliation: Department 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.
authors.forename: Sherly
authors.initials: S
authors.lastname: Mosessian
authors.forename: Sandra M
authors.initials: SM
authors.lastname: Duarte-Vogel
authors.forename: David B
authors.initials: DB
authors.lastname: Stout
authors.forename: Kenneth P
authors.initials: KP
authors.lastname: Roos
authors.forename: Gregory W
authors.initials: GW
authors.lastname: Lawson
authors.forename: Maria C
authors.initials: MC
authors.lastname: Jordan
authors.forename: Amanda
authors.initials: A
authors.lastname: Ogden
authors.forename: Cheryl
authors.initials: C
authors.lastname: Matter
authors.forename: Saman
authors.initials: S
authors.lastname: Sadeghi
authors.forename: George Q
authors.initials: GQ
authors.lastname: Mills
authors.forename: Heinrich R
authors.initials: HR
authors.lastname: Schelbert
authors.forename: Caius G
authors.initials: CG
authors.lastname: Radu
authors.forename: Johannes
authors.initials: J
authors.lastname: Czernin
authors.forename: Marcelo
authors.initials: M
authors.lastname: Couto
authors.forename: Michael E
authors.initials: ME
authors.lastname: Phelps
mesh_terms: D000047:Academies and Institutes; D000818:Animals; D003561:Cytarabine; D017277:Drug Approval; D015507:Drugs, Investigational; D005260:Female; D006801:Humans; D008297:Male; D057054:Molecular Imaging / Q000191:economics; D015335:Molecular Probes / Q000191:economics; D049268:Positron-Emission Tomography / Q000191:economics; D017207:Rats, Sprague-Dawley; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational; D015335:Molecular Probes; D003561:Cytarabine
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