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Best Practices for Preclinical In Vivo Testing of Cancer Nanomedicines.
Advanced Healthcare Materials ( IF 10.0 ) Pub Date : 2020-05-04 , DOI: 10.1002/adhm.202000110
Danielle M Valcourt 1 , Chintan H Kapadia 1 , Mackenzie A Scully 1 , Megan N Dang 1 , Emily S Day 1, 2, 3
Affiliation  

Significant advances have been made in the development of nanoparticles for cancer treatment in recent years. Despite promising results in preclinical animal models, cancer nanomedicines often fail in clinical trials. This failure rate could be reduced by defining stringent criteria for testing and quality control during the design and development stages, and by performing carefully planned preclinical studies in relevant animal models. This article discusses best practices for the evaluation of nanomedicines in murine tumor models. First, a recommended set of experiments to perform is introduced, including discussion of the types of data to collect during these studies. This is followed by an outline of various tumor models and their clinical relevance. Next, different routes of nanoparticle administration are overviewed, followed by a summary of important controls to include in in vivo studies of nanomedicine. Finally, animal welfare considerations are discussed, and an overview of the steps involved in achieving US Food and Drug Administration approval after animal studies are completed is provided. Researchers should use this report as a guideline for effective preclinical evaluation of cancer nanomedicine. As the community adopts best practices for in vivo testing, the rate of clinical translation of cancer nanomedicines is likely to improve.

中文翻译:

癌症纳米药物临床前体内测试的最佳实践。

近年来,用于癌症治疗的纳米粒子的开发取得了重大进展。尽管在临床前动物模型中取得了有希望的结果,但癌症纳米药物在临床试验中经常失败。通过在设计和开发阶段制定严格的测试和质量控制标准,并在相关动物模型中进行精心策划的临床前研究,可以降低失败率。本文讨论了在小鼠肿瘤模型中评估纳米药物的最佳实践。首先,介绍一组推荐进行的实验,包括讨论这些研究期间要收集的数据类型。接下来是各种肿瘤模型及其临床相关性的概述。接下来,概述了纳米颗粒给药的不同途径,然后总结了纳米医学体内研究中的重要控制措施。最后,讨论了动物福利考虑因素,并概述了动物研究完成后获得美国食品和药物管理局批准所涉及的步骤。研究人员应使用该报告作为癌症纳米医学有效临床前评估的指南。随着业界采用体内测试的最佳实践,癌症纳米药物的临床转化率可能会提高。
更新日期:2020-06-24
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