Quality assurance considerations related to in-house radiopharmaceutical preparations

The Food and Drug Administration through its interpretation of the Food, Drug and Cosmetic Act with various amendments not only oversees the clinical investigation of new drugs, including short-lived radiopharmaceuticals but also monitors specific basic research protocols through the activities of the approved Radioactive Drug Research Committees. Concurrent with the technical improvements being made with positron emission tomographs is the increased availability of a variety of radiolabeled substrates possessing the unique potential to serve as indicators of in vivo alteration of biochemical processes. The syntheses of certain positron emitting radioligands with specific emphasis on the quality control procedures and current good manufacturing practices are discussed