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Table 3 Comparison of FDG with Reference Listed Drug after each update

From: Futureproofing [18F]Fludeoxyglucose manufacture at an Academic Medical Center

  RLD Requirement Historicala Phase 1a Phase 2a
Conditions of Use Neurology, oncology, cardiology Neurology, oncology, cardiology Neurology, oncology, cardiology Neurology, oncology, cardiology
Active Ingredient FDG FDG FDG FDG
Route of Administration Intravenous Intravenous Intravenous Intravenous
Dosage Form Injection Injection Injection Injection
Strength 20–300 mCi/mL (@ EOS) 24 29 33
Specific activity No-carrier-added (NCA) NCA NCA NCA
Inactive Ingredients 4.5 mg/mL NaCl in citrate buffer 4.58 mg/mL 4.55 mg/mL 4.55 mg/mL
Osmolality Isotonic Isotonic Isotonic Isotonic
  1. aHistorical: TRACERLab/Ag targets; Ph 1: FASTLab/Ag targets; Ph 2: FASTLab/Nb targets