关键词: FDA alternative testing animal testing clinical trial nondeveloping country

Mesh : Animals United States Humans Artificial Intelligence Pharmaceutical Preparations Drug Approval Drug Development United States Food and Drug Administration

来  源:   DOI:10.1002/ddr.22108

Abstract:
Animal testing is required in drug development research and is crucial for assessing the efficacy and safety of medications before they are commercialized. However, the newly furnished Food and Drug Administration Modernization Act 2.0 has given new insight into drug development. It opens a new door by offering an alternative testing method for developing a new drug without using animals. This newly proposed system may potentially significantly impact nondeveloped countries worldwide. In this study, we explore the alternative testing options such as in silico modeling, human tissue-on-chip engineering, animal-free recombinant antibodies, tissue engineering, and artificial intelligence presented by this act and discuss its implications for nondeveloped countries.
摘要:
在药物开发研究中需要进行动物测试,对于在药物商业化之前评估药物的疗效和安全性至关重要。然而,新提供的食品和药物管理局现代化法案2.0提供了新的见解药物开发。它通过提供一种替代测试方法来开发一种不使用动物的新药,从而打开了一扇新的大门。这个新提出的系统可能会对全球非发达国家产生重大影响。在这项研究中,我们探索了替代测试选项,如计算机建模,人体芯片上组织工程,无动物重组抗体,组织工程,以及该法案提出的人工智能,并讨论其对非发达国家的影响。
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