Toxicological data of anti IgE biosimilar KA

Five kinds of toxicology data, which can be divided into regular physiological data (survival date, food consumption, body weight, body temperature, organ weights), safety pharmacological data (electrocardiograph, blood pressure, breathing frequency), blood parameter (biochemical and haematological data) serum drug concentration and ADA (anti-drug antibody) was collected from cynomolgus monkeys administrated the anti-IgE antibody. Blood samples were collected and safety pharmacological data was recorded at different time points. Half of the animals were euthanised soon after the last drug administration, the other half were euthanissed at the end of the recovery period. Vital organ weights were then recorded. The raw data from all the animals of different groups were compiled and computed
Data of Table 1 comprise the survival date of cynomolgus monkeys used for sub-chronic toxicity testing anti-IgE bio-similar mAb.
Data of Table 2 comprise the food consumption of cynomolgus monkeys used for sub-chronic toxicity testing anti-IgE bio-similar mAb.
Data of Table 3 comprise the body weights of cynomolgus monkeys used for sub-chronic toxicity testing anti-IgE bio-similar mAb.
Data of Table 4 comprise the body temperature of cynomolgus monkeys used for sub-chronic toxicity testing anti-IgE bio-similar mAb
Data of Table 5 comprise the electrocardiograph data of cynomolgus monkeys used for sub-chronic toxicity testing anti-IgE bio-similar mAb
Data of Table 6 comprise the blood pressure of cynomolgus monkeys used for sub-chronic toxicity testing anti-IgE bio-similar mAb
Data of Table 7 comprise the breathing rate of cynomolgus monkeys used for sub-chronic toxicity testing anti-IgE bio-similar mAb
Data of Table 8.1 to 8.5 consists haematological profile of cynomolgus monkeys on Day-8, Day-4, Day 14, Day28 and Day 59 relative to the start date (first dose administration).
Data of Table 9.1 to 9.5 consists blood bio-chemistry profile of cynomolgus monkeys on Day-8, Day-4, Day 14, Day28 and Day 59 relative to the start date (first dose administration).
Data of Table 10 was the serum drug concentration of cynomolugs after the first and last dose administration.
The data on weights of vital organs viz brain, heart, liver, spleen, kidney, thymus and thyroid was presents in Table 11. Weights of testis, parorchis and paranephros was recorded for male animals, while for female animals it was uterus, oophoron and paranephros.
Table 12 display the OD value data obtained in ADA assay.

本数据集包含五种毒理学数据，可分为常规生理数据（存活日期、食物摄入量、体重、体温、器官重量）、安全性药理学数据（心电图、血压、呼吸频率）、血液参数（生化及血液学数据）、血清药物浓度以及抗药抗体（ADA）检测数据，这些数据均来源于接受抗-IgE抗体治疗的食蟹猴。血液样本的采集及安全性药理学数据的记录在不同时间点进行。实验动物中，有一半在最后一次给药后立即进行安乐死，另一半则在恢复期结束时被安乐死，随后记录了主要器官的重量。所有不同组别动物的原始数据均被汇编并计算。表1的数据包括用于亚慢性毒性测试的抗-IgE生物类似物食蟹猴的存活日期。表2的数据包括用于亚慢性毒性测试的抗-IgE生物类似物食蟹猴的食物摄入量。表3的数据包括用于亚慢性毒性测试的抗-IgE生物类似物食蟹猴的体重。表4的数据包括用于亚慢性毒性测试的抗-IgE生物类似物食蟹猴的体温。表5的数据包括用于亚慢性毒性测试的抗-IgE生物类似物食蟹猴的心电图数据。表6的数据包括用于亚慢性毒性测试的抗-IgE生物类似物食蟹猴的血压数据。表7的数据包括用于亚慢性毒性测试的抗-IgE生物类似物食蟹猴的呼吸频率数据。表8.1至8.5的数据包括食蟹猴在第8天、第4天、第14天、第28天和第59天（相对于首次给药日期）的血液学特征。表9.1至9.5的数据包括食蟹猴在第8天、第4天、第14天、第28天和第59天（相对于首次给药日期）的血液生化特征。表10的数据为食蟹猴在首次和最后一次给药后的血清药物浓度。表11展示了大脑、心脏、肝脏、脾脏、肾脏、胸腺和甲状腺等主要器官的重量数据。对于雄性动物，记录了睾丸、附睾和副肾的重量，而对于雌性动物，记录了子宫、卵巢和副肾的重量。表12展示了ADA检测中获得的OD值数据。