Van Norman Gail A
Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington.
JACC Basic Transl Sci. 2019 Nov 25;4(7):845-854. doi: 10.1016/j.jacbts.2019.10.008. eCollection 2019 Nov.
Animal testing is used in pharmaceutical and industrial research to predict human toxicity, and yet analysis suggests that animal models are poor predictors of drug safety in humans. The cost of animal research is high-in dollars, delays in drug approval, and in the loss of potentially beneficial drugs for human use. Human subjects have been harmed in the clinical testing of drugs that were deemed safe by animal studies. Increasingly, investigators are questioning the scientific merit of animal research. This review discusses issues in using animals to predict human toxicity in pharmaceutical development. Part 1 focuses on scientific concerns over the validity of animal research. Part 2 will discuss alternatives to animal research and their validation and use in production of human pharmaceuticals.
动物实验被用于制药和工业研究以预测人类毒性，但分析表明动物模型在预测药物对人类的安全性方面表现不佳。动物研究的成本很高，包括金钱成本、药物审批延迟以及失去潜在有益的人类用药。在动物研究中被认为安全的药物的临床试验中，人类受试者受到了伤害。越来越多的研究人员开始质疑动物研究的科学价值。本综述讨论了在药物研发中使用动物预测人类毒性的相关问题。第1部分重点关注对动物研究有效性的科学担忧。第2部分将讨论动物研究的替代方法及其在人类药物生产中的验证和应用。
