查询了跨国实验室服务提供商的历史对照数据库,以了解在十年期间(2011-2020年)用作对照动物的新西兰白兔的所有组织病理学发现。查询包括所有评估的组织,不管有没有微观发现,在美国食品药品监督管理局(FDA)或美国环境保护局批准的安全性测试研究中。第二个查询包括在英国进行的对照兔子的研究,这些兔子用于符合医疗保健产品监管机构(MHRA)和/或欧洲药品管理局(EMA)的研究。在英国和欧盟提供监管监督,分别。炎症(混合或单核细胞)的浸润通常在各种器官,包括心脏,消化道,肌肉,甲状腺,肾,膀胱,眼睑,眼结构,Harderian腺体,泪腺,还有肺.主动脉出现矿化,肾,膀胱,和卵巢。还注意到心肌变性/坏死,和肌肉注射部位的皮肤,肌肉和隔膜的变性/再生,胰腺和甲状腺的异位组织,唾液腺中的嗜碱性病灶,肾上腺空泡增多/减少,增加/减少淋巴结的淋巴细胞细胞数,淋巴结中的静脉内红细胞,胸腺萎缩,骨髓中脂肪细胞增加,肝脏和胆囊的炎症细胞病灶,泪腺萎缩,肾小管嗜碱性粒细胞,变性/再生,和扩张;输卵管囊肿;在睾丸中,变性/萎缩,细胞碎片,扩张,精子减少和生精小管节段性发育不全;睾丸和精囊鳞状化生。
The historical control database of a multinational laboratory services provider was queried for all histopathologic findings in New Zealand White rabbits which were used as control animals during a ten-year period (2011-2020). The query included all evaluated tissues, with or without microscopic findings, in studies conducted for safety testing for regulatory approval by the U.S. Food and Drug Agency (FDA) or the U.S. Environmental Protection Agency. A second query included studies conducted in the United Kingdom for control rabbits used in studies compliant with the Healthcare Products Regulatory Agency (MHRA) and/or the European Medicines Agency (EMA), which provide regulatory oversight in the United Kingdom and European Union, respectively. Infiltrates of inflammatory (mixed or mononuclear) cells were commonly noted in various organs including heart, digestive tract, muscle, thyroid, kidney, urinary bladder, eyelid, ocular structures, harderian gland, lacrimal gland, and lung. Mineralization was noted in aorta, kidney, urinary bladder, and ovary. Also noted were degeneration/necrosis in the myocardium, and intramuscular injection sites of the skin, degeneration/regeneration of muscle and diaphragm, ectopic tissue in the pancreas and thyroid, basophilic foci in salivary gland, increased/decreased vacuolation in adrenal gland, increased/decreased lymphocytic cellularity of lymph nodes, intrasinusoidal erythrocytes in lymph nodes, thymic atrophy, increased adipocytes in bone marrow, inflammatory cell foci in the liver and gall bladder, lacrimal gland atrophy, renal tubule basophilia, degeneration/regeneration, and dilatation; oviduct cyst; in the testis, degeneration/atrophy, cellular debris, dilatation, decreased sperm and segmental hypoplasia of seminiferous tubules; and squamous metaplasia of the testis and seminal vesicle.