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药物的非临床发育神经毒性(Developmental neurotoxicity,DNT)研究是药物非临床安全性评价的重要组成部分,通常与生殖发育毒性(Developmental And Reproductive Toxicity,DART)研究相结合。由于大分子生物技术药物多具有高度的种属特异性,在大鼠和兔体内不能或较少产生药理学应答,因此生物技术药物在评价DART时往往使用与人类更为接近的非人灵长类动物(Non-human Primates,NHPs)。非人灵长类动物的生理特征与人类高度类似,行为高度进化,具有高级的解决问题的能力及复杂的社会关系,因此特别适合用于生物技术药物的非临床DNT研究。本文综述了非人灵长类动物的发育神经毒性评价方法,为评价非人灵长类的神经行为学提供了概况,以期更好的研究药物的发育神经毒性。
Developmental neurotoxicity (DNT) studies of drugs are an important part of non-clinical safety evaluation of drugs and are often combined with studies of Developmental And Reproductive Toxicity (DART). Because of the high species specificity of macromolecular biotech drugs and their limited or no pharmacologic response in rats and rabbits, biotech drugs often use non-human primates that are more closely linked to humans in the evaluation of DART Non-human Primates (NHPs). Non-human primates are highly physiologically similar to humans, highly evolved, have advanced problem-solving skills and complex social relationships and are therefore particularly suitable for non-clinical DNT studies of biotech drugs. This review summarizes the developmental neurotoxicity assessment of non-human primates and provides an overview of neurobehavioral assessment of non-human primates in order to better study the developmental neurotoxicity of the drug.