毒理学筛查
Toxicological screening.
作者信息
Parasuraman S
机构信息
Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
出版信息
J Pharmacol Pharmacother. 2011 Apr;2(2):74-9. doi: 10.4103/0976-500X.81895.
Abstract
Toxicity testing of new compounds is essential for drug development process. The preclinical toxicity testing on various biological systems reveals the species-, organ- and dose- specific toxic effects of an investigational product. The toxicity of substances can be observed by (a) studying the accidental exposures to a substance (b) in vitro studies using cells/ cell lines (c) in vivo exposure on experimental animals. This review mainly focuses on the various experimental animal models and methods used for toxicity testing of substances. The pre-clinical toxicity testing helps to calculate "No Observed Adverse Effect Level" which is needed to initiate the clinical evaluation of investigational products.
摘要
新化合物的毒性测试对于药物研发过程至关重要。在各种生物系统上进行的临床前毒性测试揭示了研究产品的物种、器官和剂量特异性毒性作用。物质的毒性可以通过以下方式观察：(a) 研究物质的意外暴露情况；(b) 使用细胞/细胞系进行体外研究；(c) 在实验动物上进行体内暴露。本综述主要关注用于物质毒性测试的各种实验动物模型和方法。临床前毒性测试有助于计算 “未观察到不良反应水平”，这是启动研究产品临床评估所必需的。
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