未观察到不良反应水平
不利影响
参考剂量
毒理
生物信息学
药理学
医学
毒性
风险评估
计算机科学
生物
内科学
计算机安全
生物化学
基因
作者
Fabiola Pizzo,Domenico Gadaleta,Emilio Benfenati
标识
DOI:10.1007/978-1-0716-1960-5_11
摘要
Many regulatory contexts require the evaluation of repeated-dose toxicity (RDT) studies conducted in laboratory animals. The main outcome of RDT studies is the identification of the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) that are normally used as point of departure for the establishment of health-based guidance values. Since in vivo RDT studies are expensive and time-consuming, in silico approaches could offer a valuable alternative. However, NOAEL and LOAEL modeling suffer some limitations since they do not refer to a single end point but to several different effects, and the doses used in experimental studies strongly influence the results. Few attempts to model NOAEL and LOAEL have been reported. The available database and models for the prediction of NOAEL and LOAEL are reviewed here.
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