Best Practices for Preclinical In Vivo Testing of Cancer Nanomedicines
Best Practices for Preclinical In Vivo Testing of Cancer Nanomedicines
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DOI：
10.1002/adhm.202000110
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发表时间：
2020-05-04
影响因子：
10
通讯作者：
Day，Emily S.
中科院分区：
文献类型：
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作者：
Valcourt，Danielle M.;Kapadia，Chintan H.;Day，Emily S.
近年来，用于癌症治疗的纳米颗粒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往往失败。通过在设计和开发阶段定义严格的测试和质量控制标准，以及在相关动物模型中进行精心计划的临床前研究，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，介绍了一组推荐的实验，包括在这些研究中收集的数据类型的讨论。其次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，然后总结了重要的控制，包括在纳米医学的体内研究。最后，动物福利的考虑进行了讨论，并在动物研究完成后，实现美国食品和药物管理局批准所涉及的步骤的概述。研究人员应该将这份报告作为癌症纳米医学有效临床前评估的指南。随着社区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。
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.