Predictivity of animal studies for human injection site reactions with parenteral drug products
Predictivity of animal studies for human injection site reactions with parenteral drug products
复制标题
DOI：
10.1016/j.etp.2008.04.003
复制
发表时间：
2008-08-01
影响因子：
--
通讯作者：
Engelhardt, Jeffery A.
中科院分区：
文献类型：
--
作者：
Engelhardt, Jeffery A.
非临床研究对试验用药品在人体中的潜在作用的价值和预测能力经常存在争议。动物毒性研究的一般预测性主题已在多个场合进行了讨论，ILSI任务组最近进行了一项工作[Olson H等人，人类和动物药物毒性的一致性。Regul Toxicol Pharmacol 2000; 32：56-67]。本综述总结了皮肤毒性评价、组织病理学评估以及生物制药行业在注射部位反应方面的经验，并从实用的角度对标准动物研究在人体中的这些反应进行了预测。(C)2008爱思唯尔有限公司All rights reserved.
The value and predictive power of nonclinical studies for potential effects of investigational medicinal products in humans is often debated. The subject of general predictivity of animal toxicity studies has been addressed on several occasions, with one of the most recent efforts being conducted by an ILSI Task Group [Olson H, et al. Concordance of the toxicity of pharmaceuticals in humans and animals. Regul Toxicol Pharmacol 2000; 32: 56-67]. This review provides a summary of the evaluation of cutaneous toxicity, its histopathological assessment, and experience of the biopharmaceutical industry with respect to injection site reactions with parenteral drug products with a pragmatic perspective on the predictivity of standard animal studies with respect to these responses in humans. (C) 2008 Elsevier GmbH. All rights reserved.