Abstract：
To avoid adverse events in humans, toxicity studies in nonclinical species have been the foundation of safety evaluation in the pharmaceutical industry. However, it is recognized that working with animals in research is a privilege, and conscientious use should always respect the 3Rs: replacement, reduction, and refinement. In the wake of the shortages in routine nonrodent species and considering that nonanimal methods are not yet sufficiently mature, the value of the rabbit as a nonrodent species is worth exploring. Historically used in vaccine, cosmetic, and medical device testing, the rabbit is seldom used today as a second species in pharmaceutical development, except for embryo-fetal development studies, ophthalmic therapeutics, some medical devices and implants, and vaccines. Although several factors affect the decision of species selection, including pharmacological relevance, pharmacokinetics, and ADME considerations, there are no perfect animal models. In this forum article, we bring together experts from veterinary medicine, industry, contract research organizations, and government to explore the pros and cons, residual concerns, and data gaps regarding the use of the rabbit for general toxicity testing.
摘要：
为了避免人类的不良事件，非临床物种的毒性研究一直是制药行业安全性评估的基础。然而,人们认识到，在研究中与动物合作是一种特权，认真使用应始终尊重3R：替换，reduction,和细化。在常规非啮齿动物物种短缺之后，考虑到非动物方法还不够成熟，兔作为一种非啮齿动物的价值值得探讨。历史上用于疫苗，化妆品,和医疗器械测试，今天，兔子很少被用作药物开发中的第二物种，除了胚胎-胎儿发育研究，眼科治疗学,一些医疗设备和植入物，和疫苗。虽然有几个因素会影响物种选择的决定，包括药理学相关性，药代动力学和ADME注意事项，没有完美的动物模型。在这篇论坛文章中，我们汇集了兽医学专家，工业,合同研究组织，和政府来探索利弊，残余关切，以及关于使用兔子进行一般毒性测试的数据空白。
