Rats or rabbits are usually used to assess the reproductive and developmental toxicity of small-molecule drugs. However, these conventional animal models for toxicity testing are not pharmacologically relevant species for most biotechnological drugs. Therefore, non-human primates (NHPs) are most likely to be used for reproductive and developmental toxicity evaluation. InnoStar has improved the pregnancy rate of NHPs, which has greatly reduced animal use, test costs and experimental duration.
One of the first institutions receiving the GLP certification for reproductive and developmental toxicology studies (Segments I/II/III) in China
InnoStar has established a comprehensive reproductive and developmental toxicity assessment system, which meets GLP requirements in China, and has built a laboratory for assessing reproductive and developmental toxicity in Cynomolgus monkeys. InnoStar supports assessment of non-human primate's embryo-fetal developmental toxicity and enhanced pre- and post-natal toxicity and optimizes non-human primate's developmental toxicity assessment through practices, gradually improving non-human primate-based models and reference database for generations F0 and F1. It aims to provide non-clinical reproductive toxicity assessment for domestic and international customers with greater accuracy and quality. The platform provides one-stop support for toxicological assessment based on the requirements of the guidelines. It has completed several projects on fertility assessment in general toxicity studies in sexually mature monkeys, including male fertility assessment (sperm analysis and comprehensive histopathological examinations), female fertility assessment (menstrual cycle monitoring and histopathological examinations) and sex hormone level measurement.
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