FES Documentation Page
Component documents for an IND for 16-α-[18F]Fluoroestradiol ([18F]FES)
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 (Lim, JL, Zheng, L, et al: The use of 3-methoxymethyl-16 beta, 17 beta-epiestriol-O-cyclic sulfone as the precursor in the synthesis of F-18 16 alpha-fluoroestradiol. Nucl Med Biol 23:911-5, 1996). 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 [18F] FES Frequently Asked Questions before going forward. Documents in this section include:
- [18F] FES Frequently Asked Questions
- [18F] FES Investigator's Brochure as a Adobe Acrobat file or a Word document
- [18F] FES Toxicology Studies and Summaries
- [18F] FES 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] FES as an Executable or as a compressed Zip file
- Microsoft Word Generic Documentation for [18F] FES as an Executable or as a compressed Zip file
- Updated specifications for [18F] FES, for sites wishing to manufacture IND PET agents under the NCI IND
For additional information, contact:
Ismahan Ugas, B.A.
Email: ugasi@mail.nih.gov
Phone: 240-276-6020