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Last Updated: 09/13/17

FMISO Documentation Page

Component Documents for an IND for [18F]Fluoromisonidazole, 1H-1-(3-[18F]-Fluoro-2-Hydroxy-Propyl)-2-Nitro-Imidazole ([18F]FMISO)

These documents include a full set of manufacturing and QC documents and an Investigator Drug Brochure, all of which have been accepted by the FDA as part of the NCI IND. The synthesis procedure follows that reported by Lim and Berridge (1993), An efficient radiosynthesis of [18F]FMISO. Appl. Radiat. Isot. 44, 1085-1091. Investigators at each site can implement the synthesis and testing in their radiochemistry laboratory. There is a CMC template that will need to be modified to match the local procedures (e.g. specific brands of equipment). Investigators can then write and file their own IND with the FDA by modifying the CMC section to fit local conditions and adding the Investigator's proposed Clinical protocol, and NCI will provide a letter to cross-reference the NCI IND file at FDA for pharmacology, toxicology, dosimetry, and previous human experience. You may wish to consult these FMISO Frequently Asked Questions before going forward. Documents in this section include:

For additional information, contact:

G. Craig Hill, Ph.D.
Email: hillgc@mail.nih.gov
Phone: 240-276-5913