Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals

• Published in: EJNMMI radiopharmacy and chemistry Vol. 7; no. 1; p. 18
• Main Authors: Korde, Aruna, Mikolajczak, Renata, Kolenc, Petra, Bouziotis, Penelope, Westin, Hadis, Lauritzen, Mette, Koole, Michel, Herth, Matthias Manfred, Bardiès, Manuel, Martins, Andre F., Paulo, Antonio, Lyashchenko, Serge K., Todde, Sergio, Nag, Sangram, Lamprou, Efthimis, Abrunhosa, Antero, Giammarile, Francesco, Decristoforo, Clemens
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 19.07.2022; Springer Nature B.V; SpringerOpen
• Subjects: Clinical translation; Documents; IAEA; Imaging; In vivo methods and tests; Medical innovations; Medicin och hälsovetenskap; Medicine; Medicine & Public Health; Molecular Medicine; Non-clinical testing; Nuclear Chemistry; Nuclear energy; Nuclear Medicine; Nuclear safety; Pharmaceuticals; Pharmacokinetics; Pharmacology; Pharmacotherapy; Preclinical development; Radiation; Radiation effects; Radiochemistry; Radioisotopes; Radiology; Radiopharmaceuticals; Regulations; Review; Toxicity testing; Translation; Clinical translation; Regulations; Radiopharmaceuticals; Non-clinical testing; Preclinical development; IAEA

Background The development of radiopharmaceuticals requires extensive evaluation before they can be applied in a diagnostic or therapeutic setting in Nuclear Medicine. Chemical, radiochemical, and pharmaceutical parameters must be established and verified to ensure the quality of these novel product...