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.

Details

Title
Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals
Author
Korde, Aruna 1 ; Mikolajczak, Renata 2 ; Kolenc, Petra 3 ; Bouziotis, Penelope 4 ; Westin, Hadis 5 ; Lauritzen, Mette 6 ; Koole, Michel 7 ; Herth, Matthias Manfred 8 ; Bardiès, Manuel 9 ; Martins, Andre F. 10 ; Paulo, Antonio 11 ; Lyashchenko, Serge K. 12 ; Todde, Sergio 13 ; Nag, Sangram 14 ; Lamprou, Efthimis 15 ; Abrunhosa, Antero 16 ; Giammarile, Francesco 1 ; Decristoforo, Clemens 17   VIAFID ORCID Logo 

 Vienna International Centre, Department of Nuclear Sciences and Applications, International Atomic Energy Agency (IAEA), Vienna, Austria (GRID:grid.420221.7) (ISNI:0000 0004 0403 8399) 
 Radioisotope Centre POLATOM, National Centre for Nuclear Research, Otwock, Poland (GRID:grid.450295.f) (ISNI:0000 0001 0941 0848) 
 University Medical Centre Ljubljana, Department of Nuclear Medicine, Ljubljana, Slovenia (GRID:grid.29524.38) (ISNI:0000 0004 0571 7705); University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia (GRID:grid.8954.0) (ISNI:0000 0001 0721 6013) 
 Institute of Nuclear & Radiological Sciences and Technology, Energy & Safety, National Centre for Scientific Research “Demokritos”, Athens, Greece (GRID:grid.6083.d) (ISNI:0000 0004 0635 6999) 
 Uppsala Universitet, Department of Immunology, Genetics and Pathology, Ridgeview Instruments AB, Uppsala, Sweden (GRID:grid.8993.b) (ISNI:0000 0004 1936 9457) 
 Bruker BioSpin MRI GmbH, Ettlingen, Germany (GRID:grid.423218.e) 
 Katholieke Universiteit Leuven, Nuclear Medicine and Molecular Imaging, Louvain, Belgium (GRID:grid.5596.f) (ISNI:0000 0001 0668 7884) 
 University of Copenhagen, Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, Copenhagen, Denmark (GRID:grid.5254.6) (ISNI:0000 0001 0674 042X); Copenhagen University Hospital, Department of Clinical Physiology, Nuclear Medicine and PET, Copenhagen, Denmark (GRID:grid.4973.9) (ISNI:0000 0004 0646 7373) 
 Université de Montpellier, Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Institut Régional du Cancer de Montpellier (ICM), Montpellier, France (GRID:grid.121334.6) (ISNI:0000 0001 2097 0141) 
10  Eberhard Karls University Tübingen, Department of Preclinical Imaging and Radiopharmacy, Werner Siemens Imaging Center, Tübingen, Germany (GRID:grid.10392.39) (ISNI:0000 0001 2190 1447); University of Tübingen, Cluster of Excellence iFIT (EXC 2180) “Image-Guided and Functionally Instructed Tumor Therapies”, Tübingen, Germany (GRID:grid.10392.39) (ISNI:0000 0001 2190 1447) 
11  Universidade de Lisboa, Bobadela Lrs, Centro de Ciências E Tecnologias Nucleares, Instituto Superior Técnico, Lisbon, Portugal (GRID:grid.9983.b) (ISNI:0000 0001 2181 4263) 
12  Memorial Sloan Kettering Cancer Center, Department of Radiology, New York, USA (GRID:grid.51462.34) (ISNI:0000 0001 2171 9952) 
13  University of Milano-Bicocca, Tecnomed Foundation, Department of Medicine and Surgery, Milan, Italy (GRID:grid.7563.7) (ISNI:0000 0001 2174 1754) 
14  Karolinska Institutet and Stockholm County Council, Department of Clinical Neuroscience, Centre for Psychiatry Research, Stockholm, Sweden (GRID:grid.4714.6) (ISNI:0000 0004 1937 0626) 
15  Lefkippos Attica Technology Park-N.C.S.R Demokritos, Bioemtech, Athens, Greece (GRID:grid.6083.d) (ISNI:0000 0004 0635 6999) 
16  University of Coimbra, ICNAS/CIBIT, Institute for Nuclear Sciences Applied to Health, Coimbra, Portugal (GRID:grid.8051.c) (ISNI:0000 0000 9511 4342) 
17  Medical University Innsbruck, Department of Nuclear Medicine, Innsbruck, Austria (GRID:grid.5361.1) (ISNI:0000 0000 8853 2677) 
Publication year
2022
Publication date
Dec 2022
Publisher
Springer Nature B.V.
e-ISSN
2365-421X
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2691609196
Copyright
© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.