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Updated: Jun 11, 2025

Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-Labelled Nano Molecules
Published on: October 4, 2024
Radiopharmaceutical good practices: Regulation between hospital and industry
Alain Faivre-Chauvet1,2, Cécile Bourdeau3, Mickaël Bourgeois1,2,3
1Nantes-Angers Cancer Research Center CRCI2NA, University of Nantes, INSERM UMR1307, CNRS-ERL6075, Nantes, France.
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.
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