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- Title
Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals.
- 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
- Abstract
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 products. Main body: To provide supportive evidence for the expected human in vivo behaviour, particularly related to safety and efficacy, additional tests, often referred to as "non-clinical" or "preclinical" are mandatory. This document is an outcome of a Technical Meeting of the International Atomic Energy Agency. It summarises the considerations necessary for non-clinical studies to accommodate the regulatory requirements for clinical translation of radiopharmaceuticals. These considerations include non-clinical pharmacology, radiation exposure and effects, toxicological studies, pharmacokinetic modelling, and imaging studies. Additionally, standardisation of different specific clinical applications is discussed. Conclusion: This document is intended as a guide for radiopharmaceutical scientists, Nuclear Medicine specialists, and regulatory professionals to bring innovative diagnostic and therapeutic radiopharmaceuticals into the clinical evaluation process in a safe and effective way.
- Subjects
INTERNATIONAL Atomic Energy Agency; RADIOPHARMACEUTICALS; NUCLEAR medicine; MEDICAL specialties &; specialists; CLINICAL medicine
- Publication
EJNMMI Radiopharmacy & Chemistry, 2022, Vol 7, Issue 1, p1
- ISSN
2365-421X
- Publication type
Article
- DOI
10.1186/s41181-022-00168-x