Radioactive drugs in drug development research: quality assurance issues.
Increasing number of new drugs, drug formulations and drug delivery systems is evaluated using noninvasive imaging methods. A successful use of new drugs and radiopharmaceuticals depends on their proven quality. This review provides a brief outline of the quality control procedures required for radiolabeled drugs within the context of the existing regulations.
Baranowska-Kortylewicz
J
J
Department of Radiation Oncology, J. Bruce Henriksen Cancer Research Laboratories, 986850 Nebraska Medical Center, Omaha, Nebraska 68198-6850, USA. jbaranow@unmc.edu
D004731:Endotoxins / Q000032:analysis; D006801:Humans; D006863:Hydrogen-Ion Concentration; D009994:Osmolar Concentration; D010316:Particle Size; D011786:Quality Control; D019275:Radiopharmaceuticals / Q000737:chemistry* / Q000493:pharmacokinetics / Q000592:standards; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration
D004731:Endotoxins; D019275:Radiopharmaceuticals