[Evaluation of the quality of radiopharmaceutics].

Meditsinskaia radiologiia Pub Date : 1991-01-01
V N Korsunskiĭ, N F Tarasov, G E Kodina, A B Malinin
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引用次数: 0

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.

[放射性药品质量评价]。
作者考虑了一组药物的临床要求与质量分析指标的相互关系:放射性核素纯度(以剂量负荷和可视化质量为标准);放射化学纯度(与被调查器官中必要的积累水平的相互关系);化学外加剂的安全标准及其对诊断质量的影响临床质量标准正在讨论中);系统的差异蓄积系数:研究对象器官-邻近组织;特异性;药代动力学等指标。在上述标准的基础上对RP质量进行正确、全面的评价,在很大程度上决定了在特定的放射性核素诊断方法中选择一种标记化合物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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