Table 4 Summary of the target product profile at the beginning of the innovation process.
Feature | Information |
|---|---|
Name | [\(^{18}\)F]F-Al-PSMA-11 |
Short Description | \(^{18}\)F-radiopharmaceutical composed of a PSMA receptor targeting agent and a chelator for Al-\(^{18}\)F |
Indication | Diagnosis of prostate cancer by PET imaging |
Composition | [\(^{18}\)F]F-Al-PSMA-11 formulated solution containing 10% EtOH |
Mechanism of action | Specific recognition of PSMA receptor |
Route of administration | Intravenous |
Dosage | 1–2 MBq / kg |
Market differentiation | Better image contrast for earlier detection |
Packaging | Sterile sealed glass vial |
Predicate | \(^{18}\)F-analog to [\(^{68}\)Ga]Ga-PSMA-11 |
