Korde Aruna, Mikolajczak Renata, Kolenc Petra, Bouziotis Penelope, Westin Hadis, Lauritzen Mette, Koole Michel, Herth Matthias Manfred, Bardiès Manuel, Martins Andre F, Paulo Antonio, Lyashchenko Serge K, Todde Sergio, Nag Sangram, Lamprou Efthimis, Abrunhosa Antero, Giammarile Francesco, Decristoforo Clemens
Department of Nuclear Sciences and Applications, International Atomic Energy Agency (IAEA), Vienna International Centre, PO Box 100, 1400, Vienna, Austria.
Radioisotope Centre POLATOM, National Centre for Nuclear Research, Andrzej Soltan 7, 05-400, Otwock, Poland.
EJNMMI Radiopharm Chem. 2022 Jul 19;7(1):18. doi: 10.1186/s41181-022-00168-x.
The development of radiopharmaceuticals requires extensive evaluation before they can be applied in a diagnostic or therapeutic setting in Nuclear Medicine. Chemical, radiochemical, and pharmaceutical parameters must be established and verified to ensure the quality of these novel products.
To provide supportive evidence for the expected human in vivo behaviour, particularly related to safety and efficacy, additional tests, often referred to as "non-clinical" or "preclinical" are mandatory. This document is an outcome of a Technical Meeting of the International Atomic Energy Agency. It summarises the considerations necessary for non-clinical studies to accommodate the regulatory requirements for clinical translation of radiopharmaceuticals. These considerations include non-clinical pharmacology, radiation exposure and effects, toxicological studies, pharmacokinetic modelling, and imaging studies. Additionally, standardisation of different specific clinical applications is discussed.
This document is intended as a guide for radiopharmaceutical scientists, Nuclear Medicine specialists, and regulatory professionals to bring innovative diagnostic and therapeutic radiopharmaceuticals into the clinical evaluation process in a safe and effective way.
放射性药物在核医学的诊断或治疗环境中应用之前，需要进行广泛评估。必须确定并验证化学、放射化学和药学参数，以确保这些新产品的质量。
为了为预期的人体体内行为提供支持性证据，特别是与安全性和有效性相关的证据，通常称为“非临床”或“临床前”的额外测试是必不可少的。本文件是国际原子能机构技术会议的成果。它总结了非临床研究为满足放射性药物临床转化的监管要求所必需的考虑因素。这些考虑因素包括非临床药理学、辐射暴露与影响、毒理学研究、药代动力学建模和成像研究。此外，还讨论了不同特定临床应用的标准化问题。
本文件旨在为放射性药物科学家、核医学专家和监管专业人员提供指导，以安全有效的方式将创新的诊断和治疗性放射性药物引入临床评估过程。
