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:
- [18F] FMISO Frequently Asked Questions
- [18F] FMISO Investigator’s Brochure as an Adobe PDF document or Microsoft Word document.
- Please see documentation for [18F] FMISO 14-day toxicology and Ames test information
- The [18F] FMISO Production Documents are presented in Adobe Acrobat and Microsoft Word formats, either in executable or ZIP format, to be maximally compatible with the computer system being downloaded into. The files are large in any format and should be downloaded with a fast Internet link:
- Adobe PDF Generic Documentation for [18F] FMISO as a compressed Zip file
- Microsoft Word Generic Documentation for [18F] FMISO as an Executable or as a compressed Zip file
- Updated specifications for [18F] FMISO, for sites wishing to manufacture IND PET agents under the NCI IND
- Comprehensive Adverse Events and Potential Risks List (CAEPR) for [18F] FMISO
For additional information, contact:
Ismahan Ugas, B.A.
Email: ugasi@mail.nih.gov
Phone: 240-276-6020