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

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...

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Published inEJNMMI 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
LanguageEnglish
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
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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.
AbstractList BACKGROUNDThe 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 BODYTo 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. CONCLUSIONThis 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.
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.
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.
ArticleNumber 18
Author Mikolajczak, Renata
Koole, Michel
Bardiès, Manuel
Korde, Aruna
Todde, Sergio
Westin, Hadis
Nag, Sangram
Herth, Matthias Manfred
Martins, Andre F.
Decristoforo, Clemens
Lauritzen, Mette
Abrunhosa, Antero
Bouziotis, Penelope
Paulo, Antonio
Lamprou, Efthimis
Kolenc, Petra
Giammarile, Francesco
Lyashchenko, Serge K.
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  surname: Lyashchenko
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Issue 1
Keywords Clinical translation
Regulations
Radiopharmaceuticals
Non-clinical testing
Preclinical development
IAEA
Language English
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Snippet Background The development of radiopharmaceuticals requires extensive evaluation before they can be applied in a diagnostic or therapeutic setting in Nuclear...
BackgroundThe development of radiopharmaceuticals requires extensive evaluation before they can be applied in a diagnostic or therapeutic setting in Nuclear...
BACKGROUNDThe development of radiopharmaceuticals requires extensive evaluation before they can be applied in a diagnostic or therapeutic setting in Nuclear...
Abstract Background The development of radiopharmaceuticals requires extensive evaluation before they can be applied in a diagnostic or therapeutic setting in...
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SubjectTerms 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
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Title Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals
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