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.

Korde, A., Mikolajczak, R., Kolenc, P., Bouziotis, P., Westin, H., Lauritzen, M., et al. (2022). Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals. EJNMMI RADIOPHARMACY AND CHEMISTRY, 7(1) [10.1186/s41181-022-00168-x].

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

Todde S.;
2022

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.
Articolo in rivista - Articolo scientifico
Clinical translation; IAEA; Non-clinical testing; Preclinical development; Radiopharmaceuticals; Regulations;
English
19-lug-2022
2022
7
1
18
open
Korde, A., Mikolajczak, R., Kolenc, P., Bouziotis, P., Westin, H., Lauritzen, M., et al. (2022). Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals. EJNMMI RADIOPHARMACY AND CHEMISTRY, 7(1) [10.1186/s41181-022-00168-x].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/408211
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