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临床前治疗放射性药物开发的方面和前景。

Aspects and prospects of preclinical theranostic radiopharmaceutical development.

机构信息

Department of Radiology, Mayo Clinic, Rochester, MN 55905, USA.

Department of Oncology, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, T6G 1Z2 Canada.

出版信息

Theranostics. 2024 Oct 7;14(17):6446-6470. doi: 10.7150/thno.100339. eCollection 2024.

DOI:10.7150/thno.100339
PMID:39479448
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11519794/
Abstract

This article provides an overview of preclinical theranostic radiopharmaceutical development, highlighting aspects of the preclinical development stages that can lead towards a clinical trial. The key stages of theranostic radiopharmaceutical development are outlined, including target selection, tracer development, radiopharmaceutical synthesis, automation and quality control, radiopharmaceutical analysis, selecting a suitable model, preclinical imaging and pharmacokinetic analysis, preclinical therapeutic analysis, dosimetry, toxicity, and preparing for clinical translation. Each stage is described and augmented with examples from the literature. Finally, an outlook on the prospects for the radiopharmaceutical theranostics field is provided.

摘要

本文概述了临床前治疗放射性药物的开发，重点介绍了有助于临床试验的临床前开发阶段的各个方面。概述了治疗放射性药物开发的关键阶段，包括靶标选择、示踪剂开发、放射性药物合成、自动化和质量控制、放射性药物分析、选择合适的模型、临床前成像和药代动力学分析、临床前治疗分析、剂量学、毒性以及为临床转化做准备。每个阶段都结合文献中的示例进行了描述和说明。最后，对放射性药物治疗领域的前景进行了展望。

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Front Nucl Med. 2022 Sep 7;2:990330. doi: 10.3389/fnume.2022.990330. eCollection 2022.
2
quantitative SPECT imaging of actinium-226: feasibility and proof-of-concept.锕-226 的定量 SPECT 成像：可行性和概念验证。
Phys Med Biol. 2024 Jul 16;69(15). doi: 10.1088/1361-6560/ad5c37.
3
How to design a theranostic trial?如何设计一项治疗诊断试验？
Endocr Oncol. 2024 May 10;4(1):e230045. doi: 10.1530/EO-23-0045. eCollection 2024 Jan 1.
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Construction of the Bioconjugate Py-Macrodipa-PSMA and Its In Vivo Investigations with Large La and Small Sc Radiometal Ions.生物共轭物Py-Macrodipa-PSMA的构建及其与大尺寸镧和小尺寸钪放射性金属离子的体内研究。
Eur J Inorg Chem. 2023 Dec 12;26(35). doi: 10.1002/ejic.202300457. Epub 2023 Sep 20.
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Implementing Ac-225 labelled radiopharmaceuticals: practical considerations and (pre-)clinical perspectives.实施锕-225标记的放射性药物：实际考量与（临床前）临床前景
EJNMMI Radiopharm Chem. 2024 Feb 6;9(1):9. doi: 10.1186/s41181-024-00239-1.
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Nucl Med Biol. 2024 Jan-Feb;128-129:108875. doi: 10.1016/j.nucmedbio.2024.108875. Epub 2024 Jan 6.
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Carrier systems of radiopharmaceuticals and the application in cancer therapy.放射性药物的载体系统及其在癌症治疗中的应用。
Cell Death Discov. 2024 Jan 9;10(1):16. doi: 10.1038/s41420-023-01778-3.
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Position paper to facilitate patient access to radiopharmaceuticals: considerations for a suitable pharmaceutical regulatory framework.促进患者获得放射性药物的立场文件：关于合适药品监管框架的考量
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