Nonclinical tests are considered crucial for understanding the safety of investigational medicines. However, the effective translation from nonclinical to human application is limited and must be improved. Drug development stakeholders are working to advance human-based in vitro and in silico methods that may be more predictive of human efficacy and safety in vivo because they enable scientists to model the direct interaction of drugs with human cells, tissues, and biological processes. Here, we recommend test-neutral regulations; increased funding for development and integration of human-based approaches; support for existing initiatives that advance human-based approaches; evaluation of new approaches using human data; establishment of guidelines for procuring human cells and tissues for research; and additional training and educational opportunities in human-based approaches.

非临床测试被认为对于了解研究药物的安全性至关重要。但是，从非临床应用到人类应用的有效转换是有限的，必须加以改进。药物开发利益相关者正在努力推进以人为基础的体外和计算机模拟方法，这些方法可能更能预测人体内的功效和安全性因为它们使科学家能够模拟药物与人类细胞，组织和生物过程的直接相互作用。在这里，我们建议测试中性法规；增加用于发展和整合以人为本的方法的资金；支持促进基于人的方法的现有举措；使用人类数据评估新方法；建立采购人类细胞和组织进行研究的指导方针；以及其他基于人的方法的培训和教育机会。