Quality Assurance Considerations Related to “In-House” Radiopharmaceutical Preparations Utilizing Positron Emitting Radionuclides

  • R. Finn
  • T. Boothe


The FDA oversees the clinical investigation of new and investigational drugs, including short lived radiopharmaceuticals, as well as monitors the use of these in basic research protocols through the activities of the approved Radioactive Drug Research Committee. Concurrent with the technical improvements being made in imaging techniques such as Positron Emission Tomography (PET) is the increasing availability of a variety of radiolabelled substrates possessing the unique potential to serve as indicators of in vivo alteration of biochemical processes. In order to comply with regulatory requirements for “in-house” manufactured radiopharmaceuticals, the safety of the formulated products and the standards of the manufacturing facility must be clearly demonstrated through information provided to the regulatory agency. Difficult challenges to the investigators include not only qualitative identification but also quantitation of various impurity levels. The synthesis of two fluorine-18 labeled radioligands will serve to emphasize the detailed efforts being made to provide a finished radiopharmaceutical.


Positron Emission Tomography Positron Emission Tomograph Radionuclidic Purity Local Cerebral Glucose Utilization Cyclotron Facility 
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Copyright information

© Springer Science+Business Media New York 1991

Authors and Affiliations

  • R. Finn
    • 1
  • T. Boothe
    • 2
  1. 1.Cyclotron FacilityMemorial Sloan Kettering Cancer CenterNew YorkUSA
  2. 2.Cyclotron FacilityMount Sinai Medical CenterMiami BeachUSA

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