The main issues of quality assurance of radiopharmaceuticals

Abstract

One of the prerequisites for successful application of nuclear medicine technologies is the production and clinical use of radiopharmaceuticals (RPs) of a reliably high quality. The aim of the review is to discuss specific properties of RPs, which stipulate specific approaches to their production (or preparation) and quality control. The decisive requirement for the management of RPs at all stages of their life cycle is the observance of the radiation safety rules and regulations. The paper considers the main approaches to assessing the risks of medical radiation exposure to patients and radiation protection of nuclear medicine staff. The choice of a particular quality parameter and the corresponding analytical procedure should be made taking into account the duration of the test, which, like the production time, should be comparable with the radionuclide half-life. The feasibility of the analytical procedure should also be taken into account, given the high radioactivity of the samples tested. Now that theranostics has caught on, new approaches are being developed all over the world concerning regulatory aspects of transition from preclinical studies of RPs to clinical trials, because, according to experts, this is becoming a key condition for rapid implementation of nuclear medicine achievements. The results and conclusions of the present study can be used in the development and expert review of monographs and other specifications required for RP marketing and use. The results of the analysis suggest that it is necessary to develop specific requirements and guidelines for RP testing and evaluation for their successful promotion on the EAEU market.