Toxicological screening.
Toxicological screening.
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DOI：
10.4103/0976-500x.81895
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发表时间：
2011-04
影响因子：
0.2
通讯作者：
Parasuraman S
中科院分区：
文献类型：
--
作者：
Parasuraman S
新化合物的毒性试验是药物开发过程中必不可少的环节。临床前对各种生物系统的毒性试验揭示了研究产品的物种、器官和剂量特异性毒性效应。物质的毒性可以通过(a)研究意外暴露于某种物质(b)使用细胞/细胞系进行的体外研究(c)在实验动物身上暴露来观察。本文主要综述了用于物质毒性试验的各种实验动物模型和方法。临床前毒性测试有助于计算“未观察到的不良反应水平”，这是启动研究产品的临床评估所需要的。
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.