2021
DOI: 10.1093/jphsr/rmab033
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Radiopharmaceutical preparations: what are the legislative differences across Europe?

Abstract: Objectives Radiopharmaceuticals, since the discovery of the first medical application of radioactive isotope, have been essential therapeutics for the diagnosis and treatment of numerous diseases. Since the Directive 2001/83/EC entered in force, European regulatory authorities have established a harmonised framework to set quality requirements for the industrial production of radiopharmaceuticals. However, little is known about the harmonisation of extemporaneous preparation of radiopharmaceu… Show more

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