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作 者:郑锦芬 黄芝瑛[2] 周晓冰[1] 赵曼曼 王三龙[1] ZHENG Jinfen;HUANG Zhiying;ZHOU Xiaobing;ZHAO Manman;WANG Sanlong(National Center for Safety Evaluation of Drugs,National Institutes for Food and Drug Control,Beijing 100176,China;School of Pharmaceutical Sciences,Sun Yat-Sen University,Guangzhou 510006,China)
机构地区:[1]中国食品药品检定研究院国家药物安全评价监测中心、药物非临床安全评价研究北京市重点实验室,北京100176 [2]中山大学药学院,广东广州510006
出 处:《药物评价研究》2022年第6期1194-1199,共6页Drug Evaluation Research
基 金:中国食品药品检定研究院中青年发展研究基金课题(2020C1)。
摘 要:生殖发育毒性评价是药物安全性评价的重要组成部分。家兔属兔科兔形目,是药物生殖发育毒性评价的非啮齿类哺乳动物模型之一,但是其相关研究较啮齿动物少,对不同种属动物模型进行药物生殖发育毒性评价有助于提高风险评估的准确性。从生育力与早期胚胎发育毒性试验、胚胎-胎仔发育毒性试验、围产期发育毒性试验和体外生殖发育毒性评价等方面综述了家兔在药物生殖发育毒性评价中的研究进展,并探讨了家兔在药物生殖发育毒性评价研究中存在的问题及今后的发展方向,以期为今后研究提供参考。Developmental and reproductive toxicity evaluation is an important part of drug safety evaluation.Rabbit,a member of the Lagomorpha order,are one of the non-rodent animal models for drug developmental and reproductive toxicity evaluation.However,there are fewer related studies than rodents,and the evaluation of drug developmental and reproductive toxicity in different species animal models can help improve the accuracy of risk assessment.This paper mainly review the the research progress of drug developmental and reproductive toxicity evaluation in rabbit,including fertility and early embryonic development toxicity study,embryo-fetal developmental toxicity study,pre-postnatal and postnatal development toxicity study and in vitro developmental and reproductive toxicity evaluation,and also discuss the problems and future development directions in the evaluation of drug reproductive and developmental toxicity in rabbit,hoping to provide references for the follow-up research.
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