| Added by | JPPOUGET |
|---|---|
| Group name | EquipeJPP |
| Item Type | Journal Article |
| Title | Practical considerations for navigating the regulatory landscape of non-clinical studies for clinical translation of radiopharmaceuticals |
| Creator | Korde et al. |
| Author | Aruna Korde |
| Author | Renata Mikolajczak |
| Author | Petra Kolenc |
| Author | Penelope Bouziotis |
| Author | Hadis Westin |
| Author | Mette Lauritzen |
| Author | Michel Koole |
| Author | Matthias Manfred Herth |
| Author | Manuel Bardiès |
| Author | Andre F. Martins |
| Author | Antonio Paulo |
| Author | Serge K. Lyashchenko |
| Author | Sergio Todde |
| Author | Sangram Nag |
| Author | Efthimis Lamprou |
| Author | Antero Abrunhosa |
| Author | Francesco Giammarile |
| Author | Clemens Decristoforo |
| 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. |
| Publication | EJNMMI radiopharmacy and chemistry |
| Volume | 7 |
| Issue | 1 |
| Pages | 18 |
| Date | 2022-07-19 |
| Journal Abbr | EJNMMI Radiopharm Chem |
| Language | eng |
| DOI | 10.1186/s41181-022-00168-x |
| ISSN | 2365-421X |
| Library Catalog | PubMed |
| Extra | Number: 1 PMID: 35852679 PMCID: PMC9296747 |
| Tags | Clinical translation, IAEA, Non-clinical testing, Position paper, Preclinical development, Radiopharmaceuticals, Regulations |
| Date Added | 2023/11/23 - 12:44:37 |
| Date Modified | 2024/12/15 - 11:22:12 |
| Notes and Attachments | PubMed entry (Attachment) Texte intégral (Attachment) |
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