Koziorowski J, Behe M, Decristoforo C, Ballinger J, Elsinga P, Ferrari V, Kolenc Peitl P, Todde S, Mindt T L
Department of Radiation Physics and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
Center for Radiopharmaceutical Sciences ETH-PSI-USZ Paul-Scherrer-Institute, 5232 Villigen-PSI, Switzerland.
EJNMMI Radiopharm Chem. 2017;1(1):1. doi: 10.1186/s41181-016-0004-6. Epub 2016 Mar 21.
This is a position paper of the Radiopharmacy Committee of the EANM (European Association of Nuclear Medicine) addressing toxicology studies for application of new diagnostic and therapeutic radiopharmaceuticals (RP) that are not approved (i.e., not having a marketing authorization or a monograph in the European Pharmacopoeia), excluding endogenous and ubiquitous substances in humans. This paper discusses the requirements for clinical trials with radiopharmaceuticals for clinical research applications, not necessarily intended to aim at a marketing authorization. If marketing authorization is intended, scientific advice of the competent authorities is mandatory and cannot be replaced by this position paper. The position paper reflects the view of the Radiopharmacy Committee of the EANM and can be used as a basis for discussions with the responsible authorities.
这是欧洲核医学协会（EANM）放射性药物委员会的一份立场文件，涉及新型诊断和治疗用放射性药物（RP）应用的毒理学研究，这些放射性药物未获批准（即没有上市许可或欧洲药典专论），不包括人体内源性和普遍存在的物质。本文讨论了用于临床研究应用的放射性药物临床试验的要求，这些应用不一定旨在获得上市许可。如果打算获得上市许可，主管当局的科学建议是强制性的，本立场文件不能替代该建议。本立场文件反映了EANM放射性药物委员会的观点，可作为与相关当局讨论的基础。
