Ellegaard Göttingen Minipigs, Soroe Landevej 302, DK-4261 Dalmose, Denmark.
Int J Toxicol. 2012 Nov-Dec;31(6):507-28. doi: 10.1177/1091581812462039. Epub 2012 Nov 6.
Over the past 3 decades minipigs have moved from being an obscure alternative to dogs and nonhuman primates to being a standard animal model in regulatory toxicity studies. This article covers the use of minipigs as a model in the context of nonclinical drug safety and provides an overview of the minipig's developmental history and relates minipigs to other animal species commonly used in toxicology; and the minipig's translational power is supported by 43 case studies of marketed drug products covered. Special focus is given to criteria for selecting minipigs in nonclinical programs supporting the development of new medicines; the use of swine in the assessment of food additives, agrochemicals, and pesticides; as well as a regulatory perspective on the use of minipigs in Food and Drug Administration (FDA)-regulated products. This article presents the main points conveyed at a symposium held at the 2010 American College of Toxicology meeting in Baltimore, Maryland.
在过去的 30 年中,小型猪已经从一种鲜为人知的狗和非人类灵长类动物的替代物,发展成为监管毒理学研究中的标准动物模型。本文介绍了小型猪作为非临床药物安全性模型的应用,并概述了小型猪的发展历史,以及与其他常用于毒理学的动物物种的关系;并通过涵盖的 43 个已上市药物产品的案例研究,支持了小型猪的转化能力。本文特别关注在支持新药开发的非临床计划中选择小型猪的标准;猪在评估食品添加剂、农用化学品和农药方面的应用;以及美国食品和药物管理局(FDA)监管产品中小型猪使用的监管视角。本文介绍了在马里兰州巴尔的摩举行的 2010 年美国毒理学学会会议上举行的一次专题研讨会传达的要点。