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首页> 外文期刊>Applied in vitro toxicology. >Use of Alternative Developmental Toxicity Assays to Assess Teratogenicity Potential of Pharmaceuticals
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Use of Alternative Developmental Toxicity Assays to Assess Teratogenicity Potential of Pharmaceuticals

机译：使用替代的发育毒性检测评估潜在的致畸性药品

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Teratogenic potential of human drugs is assessed in embryo-fetal development (EFD) studies in two species as per regulatory guidelines. In vitro developmental toxicity assays can be vital in early drug development efforts to distinguish teratogenic potential of drugs, while reducing animal use. Results from two developmental toxicity in vitro assays (rat whole embryo culture assay and mouse embryonic stem cell test), were evaluated for their ability to predict the teratogenic potential of 83 compounds with known EFD outcome in rats. With an integrated model, the sensitivity and specificity for teratogens and/or embryo-lethal drugs in the presence (89% and 54%, respectively) or absence (96% and 52%, respectively) of maternal toxicity were calculated. Based on these results, we propose that a battery of assays be used to screen for potential EFD toxicity and, in combination with reduced in vivo rat EFD studies, be a part of an integrated regulatory risk assessment.
机译：畸形形成的人类药物评估的潜力在胚胎-胎仔发育(EFD)研究在两个物种按监管指南。发育毒性检测可以是至关重要的早期药物开发努力区分畸形形成的潜在的药物,而减少动物使用。毒性(在体外实验中老鼠胚胎文化分析和老鼠的胚胎干细胞测试),进行评估的能力预测83种化合物的产生畸形的潜力与已知的工艺流程图在老鼠身上的结果。集成模型、敏感性和特异性致畸剂和/或embryo-lethal药物存在与否(分别为89%和54%)(分别为96%和52%)的毒性计算。建议化验使用的电池屏幕EFD毒性和潜力结合减少体内大鼠使用EFD研究,是一个集成的一部分监管风险评估。

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