放射性药物良好规范：医院与行业之间的监管

Radiopharmaceutical good practices: Regulation between hospital and industry.

作者信息

Faivre-Chauvet Alain, Bourdeau Cécile, Bourgeois Mickaël

机构信息

Nantes-Angers Cancer Research Center CRCI2NA, University of Nantes, INSERM UMR1307, CNRS-ERL6075, Nantes, France.

Nuclear Medicine Department, University Hospital, Nantes, France.

出版信息

Front Nucl Med. 2022 Sep 7;2:990330. doi: 10.3389/fnume.2022.990330. eCollection 2022.

DOI:10.3389/fnume.2022.990330

PMID:39354961

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11440975/

Abstract

Radiopharmaceutical practices are divided into large-scale industrial manufacturing and small-scale "in-house" hospital radiopharmacy unit. The recent evolution of nuclear medicine involves deep consequences in this ever-present regulatory state, and hospital radiopharmacy units cannot be considered as contract manufacturing organizations (CMO). This review provides an updated status report of the official (and non-official) guidelines supporting the regulations required to meet hospital and industry common radiopharmaceutical manufacturing standards to facilitate the current and future innovative radiopharmaceutical development.

摘要

放射性药物实践分为大规模工业制造和小规模的医院内部放射性药房部门。核医学的最新发展在这种一直存在的监管状态下产生了深远影响，医院放射性药房部门不能被视为合同制造组织（CMO）。本综述提供了官方（和非官方）指南的最新状态报告，这些指南支持满足医院和行业通用放射性药物制造标准所需的法规，以促进当前和未来创新放射性药物的开发。