Reproductive and Developmental Toxicology of Cynomolgus Monkeys/食蟹猴生殖与发育毒理ण
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This book focuses on the fundamental theoretical knowledge, related toxicity research, and research progress in reproductive and developmental toxicology of cynomolgus monkeys. Its contents include an introduction to the cynomolgus monkey species, reproductive system anatomy and histology, reproductive physiology, developmental characteristics, similarities with humans, animal welfare management, common techniques and methods used in reproductive and developmental toxicology studies of cynomolgus monkeys, as well as fertility evaluation in repeated-dose toxicity studies, embryo-fetal developmental toxicity studies with toxicokinetics, enhanced perinatal developmental toxicity studies with toxicokinetics, and developmental toxicology evaluations in juvenile cynolgus monkeys. Classic cases are used to assess whether a test substance crosses the blood-testis barrier, placental barrier, and blood-milk barrier in cynomolgus monkeys, along with the establishment, development, and validation of methodologies for the aforementioned studies. The appendix not only includes background physiological data on cynomolgus monkeys but also, for the first time, presents over 130 normal and abnormal images-including those of embryos, fetuses, bones, viscera, and bone density-as well as B-ultrasound images of pregnant uteri and fetuses, all prepared by the chief editor's own laboratory. These materials are valuable and provide outstanding practical guidance. This book is based on the research achievements of the "Thirteenth Five-Year Plan" project of the National Major Scientific and Technological Special Project for "Major New Drug Development." It possesses high academic value and can serve as an important reference and guide for drug developers and researchers in reproductive and developmental toxicology. 本书重点阐述食蟹猴生殖与发育毒理学基础理论知识、相关毒性研究及研究进展,内容包括食蟹猴的种属介绍、生殖系统解剖及组织学、生殖生理学、发育特点、与人类的相似性、动物福利管理、食蟹猴生殖与发育毒理学研究的常见技术和方法,以及食蟹猴重复给药毒性试验中的生育力评价研究、食蟹猴胚胎-胎仔发育毒性伴随毒代动力学研究及增强的围产期发育毒性伴随毒代动力学研究、幼年食蟹猴发育毒理学评价等。通过经典案例来评估受试物是否透过食蟹猴血睾屏障、胎盘屏障和血乳屏障,并对上述研究进行方法学的建立、开发和验证。附录部分不仅收录了食蟹猴相关生理学背景数据,而且首次展示了130余幅主编实验室自行制备的胚胎、胎仔、骨骼、内脏和骨密度等正常图和畸形图,以及妊娠子宫和胎仔的B超图片,资料宝贵,指导作用突出。 本书基于国家"重大新药创制"科技重大专项"十三五"计划项目的研究成果,具有较高的学术价值,可以为从事药物开发人员及生殖与发育毒性研究人员提供重要指导与参考。
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