EANM 放射性药物质量风险管理指南。
EANM guideline on quality risk management for radiopharmaceuticals.
机构信息
Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
GE Healthcare, Pharmaceutical Diagnostics, Oslo, Norway.
出版信息
Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3353-3364. doi: 10.1007/s00259-022-05738-4. Epub 2022 Apr 7.
This document is intended as a supplement to the EANM "Guidelines on current Good Radiopharmacy Practice (cGRPP)" issued by the Radiopharmacy Committee of the EANM (Gillings et al. in EJNMMI Radiopharm Chem. 6:8, 2021). The aim of the EANM Radiopharmacy Committee is to provide a document that describes how to manage risks associated with small-scale "in-house" preparation of radiopharmaceuticals, not intended for commercial purposes or distribution.
本文件旨在补充 EANM 放射药学委员会发布的《当前良好放射药学实践指南（cGRPP）》（Gillings 等人，EJNMMI Radiopharm Chem. 6:8, 2021）。EANM 放射药学委员会的目的是提供一份文件，描述如何管理与小规模“内部”制备放射性药物相关的风险，这些放射性药物不用于商业目的或分发。
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