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[Evaluation of the quality of radiopharmaceutics]
Abstract:
The authors considered the interrelationship of clinical requirements and analytical indicators of quality for a group of pharmaceuticals: radionuclide purity (by the criteria of dose load and the quality of visualization); radiochemical purity (interrelationship with a necessary level of accumulation in investigated organs); chemical admixtures (by the criteria of safety and influence on the diagnostic quality; clinical criteria of quality were under discussion); a coefficient of differential accumulation in the system: organ under study-adjacent tissues; specificity; indices of pharmacokinetics, etc. Correct and all-round evaluation of RP quality on the basis of the above criteria determines, to a great extent, a choice of a labeled compound to be used in a specific radionuclide diagnostic method.