Toxicological data of anti IgE biosimilar KA

Published: 30 August 2022| Version 1 | DOI: 10.17632/gw2d2mkg7k.1
Contributor:
Yanchao Wang

Description

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.

Files

Categories

Toxicology, Asthma Pharmacology

License