Radiopharmaceutical good practices: Regulation between hospital and industry - Nantes Université
Article Dans Une Revue Frontiers in Nuclear Medicine Année : 2022

Radiopharmaceutical good practices: Regulation between hospital and industry

Résumé

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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hal-04758860 , version 1 (29-10-2024)

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Alain Faivre-Chauvet, Cécile Bourdeau, Mickaël Bourgeois. Radiopharmaceutical good practices: Regulation between hospital and industry. Frontiers in Nuclear Medicine, 2022, 2, pp.990330. ⟨10.3389/fnume.2022.990330⟩. ⟨hal-04758860⟩
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