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

Abstract

The FDA oversees the clin. 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 tech. improvements being made in imaging techniques, such as positron emission tomog. (PET), is the increasing availability of a variety of radiolabeled substrates possessing the unique potential to serve as indicators of in vivo alteration of biochem. processes. To comply with regulatory requirements for inhouse manufd. radiopharmaceuticals, the safety of the formulated products and the stds. of the manufg. facility must be clearly demonstrated through information provided to the regulatory agency. Difficult challenges to the investigators include not only qual. identification but also quantitation of various impurity levels. The synthesis of 2 fluorine-18 labeled radioligands will serve to emphasize the detailed efforts being made to provide a finished radiopharmaceutical. [on SciFinder(R)]