To be GMP or not to be– a radionuclide’s question

To be GMP or not to be– a radionuclide’s question

Abstract Background Radionuclides are the essential component of radiopharmaceuticals, their production needs to consider pharmaceutical regulations and guidelines, also for clinical research applications. Main body In this paper we reflect on the pharmaceutical regulatory landscape for radionuclide...

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Bibliographic Details
Main Authors: Clemens Decristoforo, Renata Mikolajczak, Clive Naidoo, Suzanne Lapi, Ferid Haddad, David Emmanuel Schmid, Lurdes Gano, Ulli Köster, Thierry Stora
Format: Article
Language:English
Published: SpringerOpen 2025-07-01
Series:EJNMMI Radiopharmacy and Chemistry
Subjects:
GMP
Radionuclides
Radiopharmaceuticals
Pharmaceutical regulations
EMA
Online Access:https://doi.org/10.1186/s41181-025-00369-0
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