TY - JOUR

T1 - Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals

AU - Korde, Aruna

AU - Mikolajczak, Renata

AU - Kolenc, Petra

AU - Bouziotis, Penelope

AU - Westin, Hadis

AU - Lauritzen, Mette

AU - Koole, Michel

AU - Herth, Matthias Manfred

AU - Bardiès, Manuel

AU - Martins, Andre F.

AU - Paulo, Antonio

AU - Lyashchenko, Serge K.

AU - Todde, Sergio

AU - Nag, Sangram

AU - Lamprou, Efthimis

AU - Abrunhosa, Antero

AU - Giammarile, Francesco

AU - Decristoforo, Clemens

N1 - Funding Information: The meeting on “Preclinical Testing of Radiopharmaceuticals,” held in Coimbra, Portugal from November 15th–19th 2021, was supported by the International Atomic Energy Agency (IAEA). The work was also supported by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) under Germany’s Excellence Strategy–EXC 2180–390900677. .

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - Clinical translation

KW - IAEA

KW - Non-clinical testing

KW - Preclinical development

KW - Radiopharmaceuticals

KW - Regulations

U2 - 10.1186/s41181-022-00168-x

DO - 10.1186/s41181-022-00168-x

M3 - Review

C2 - 35852679

AN - SCOPUS:85134421157

VL - 7

JO - EJNMMI Radiopharmacy and Chemistry

JF - EJNMMI Radiopharmacy and Chemistry

SN - 2365-421X

IS - 1

M1 - 18

ER -