欧洲核医学协会放射性药物分析方法验证指南。
EANM guideline on the validation of analytical methods for radiopharmaceuticals.
作者信息
Gillings Nic, Todde Sergio, Behe Martin, Decristoforo Clemens, Elsinga Philip, Ferrari Valentina, Hjelstuen Olaug, Peitl Petra Kolenc, Koziorowski Jacek, Laverman Peter, Mindt Thomas L, Ocak Meltem, Patt Marianne
机构信息
Department of Clinical Physiology, Nuclear Medicine and PET, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
Tecnomed Foundation, University of Milano - Bicocca, Milan, Italy.
出版信息
EJNMMI Radiopharm Chem. 2020 Feb 12;5(1):7. doi: 10.1186/s41181-019-0086-z.
BACKGROUND
To fulfil good manufacturing requirements, analytical methods for the analysis of pharmaceuticals for human and vetinary use must be validated. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has published guidance documents on the requirements for such validation activities and these have been adopted by the European Medicines Agency, The U.S. Food and Drug Administration (FDA) and other regulatory bodies. These guidance documents do not, however, fully address all the specific tests required for the analysis of radiopharmaceuticals. This guideline attempts to rectify this shortcoming, by recommending approaches to validate such methods.
RESULTS
Recommedations for the validation of analytical methods which are specific for radiopharmaceutials are presented in this guideline, along with two practical examples.
CONCLUSIONS
In order to comply with good manufacturing practice, analytical methods for radiopharmaceuticals for human use should be validated.
背景
为满足良好生产规范要求，用于人用和兽用药品分析的分析方法必须经过验证。人用药品注册技术要求国际协调会议（ICH）已发布关于此类验证活动要求的指导文件，这些文件已被欧洲药品管理局、美国食品药品监督管理局（FDA）和其他监管机构采用。然而，这些指导文件并未完全涵盖放射性药品分析所需的所有特定测试。本指南试图通过推荐验证此类方法的方法来纠正这一缺陷。
结果
本指南给出了针对放射性药品的分析方法验证建议以及两个实际示例。
结论
为符合良好生产规范，人用放射性药品的分析方法应进行验证。
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