Main description:

This publication presents strategies for the clinical implementation and quality management of positron emission tomography (PET) tracers. PET methodologies, which visualize in vivo biochemical, physiological and pharmacological processes, have revolutionized patient diagnosis and care. These technologies have opened up novel possibilities for non-invasive medical procedures and individualized patient management. The ultra-short half-lives of PET tracers, together with the busy and demanding nature of clinical settings, add to the complexities and create a need for more robust quality management programmes. This publication focuses on the clinical setting, and aims to raise awareness of the issues involved and suggest means to reduce risk. The purpose of the guidelines is to encourage a proactive approach to each aspect of parametric release and propose practical test methods for each criterion for parametric acceptance, thereby helping to ensure the quality of PET products.