The Minipig as Nonrodent Species in Toxicology-Where Are We Now?
The Minipig as Nonrodent Species in Toxicology-Where Are We Now?
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DOI：
10.1177/1091581812462039
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发表时间：
2012-11-01
影响因子：
2.2
通讯作者：
Harrouk, Wafa
中科院分区：
文献类型：
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作者：
Ganderup, Niels Christian;Harvey, Warren;Harrouk, Wafa
在过去的30年里，小型猪已经从狗和非人类灵长类动物的鲜为人知的替代品，变成了调节性毒性研究的标准动物模型。本文介绍了小型猪作为非临床药物安全性模型的使用，概述了小型猪的发展历史，并将小型猪与毒理学中常用的其他动物物种联系起来；微型猪的翻译能力得到了所涵盖的43个上市药品的案例研究的支持。特别关注在支持新药开发的非临床项目中选择小型猪的标准；在评估食品添加剂、农用化学品和杀虫剂时使用猪；以及在食品和药物管理局(FDA)监管的产品中使用小型猪的监管视角。本文介绍了在马里兰州巴尔的摩举行的2010年美国毒理学学院会议上举行的研讨会上传达的主要观点。
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.