放射性核素偶联药物的核素选择、偶联策略与质控差异的药学考量

Radionuclide selection, conjugation strategies, and CMC considerations for quality control differences in radionuclide drug conjugates

摘要

放射性核素偶联药物(radionuclide drug conjugates,RDC)凭借精准靶向与放射性杀伤能力,在核医学领域中展现出巨大潜力。本文全面综述了RDC中放射性核素的选择依据、放射性核素与靶向配体的多种偶联策略,并深入探讨了不同核素的质控差异,旨在为RDC的药学研究和审评提供参考,助力其在更多疾病中实现精准诊疗一体化。

Abstract

Radionuclide drug conjugates (RDCs) have shown great potential in the field of nuclear medicine due to their precise targeting and radioactive killing capability. This article comprehensively reviews the selection criteria of radionuclides in RDCs and various conjugation strategies between radionuclides and targeting ligands, and provides an in-depth discussion on the differences in quality control for different radionuclides, aiming to provide a reference for the pharmaceutical research and evaluation of RDCs, and help realize their integrated precision diagnosis and treatment in more diseases.

关键词

放射性核素偶联药物 / 偶联策略 / 质量控制 / 药学研究

Key words

radionuclide drug conjugates / conjugation strategy / quality control / pharmaceutical research

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基金资助

长三角区域药品领域创新与高质量发展监管科学研究资助项目(24692122700)