Technical services
Developmental and Reproductive Toxicology
Developmental and Reproductive Toxicology
Developmental and Reproductive Toxicology (DART) studies are an essential component of safety evaluations for pharmaceuticals and chemicals (ICH M3, S5, S6; OECD 421, 422, 443, 414, 415, 416). Our DART department boasts extensive experience and can provide clients with a comprehensive suite of reproductive and developmental toxicity tests that comply with the guidelines set forth by the U.S. FDA, U.S. EPA, ICH, OECD, and CFDA. All tests are conducted in strict accordance with international GLP regulations. Our years of accumulated historical control databases, a stable technical team, and highly qualified senior researchers ensure that we can deliver high-quality services to our clients promptly and efficiently.
· Fertility and Early Embryonic Development Toxicity Study (Seg I)
· Embryo-Fetal Development Toxicity Study (Seg II)
· Perinatal Developmental Toxicity Study (Seg III)
· Enhanced Pre- and Postnatal Developmental Study (ePPND) in Rhesus Monkeys with Booster Immunization
· Crab-eating macaque embryo-fetal development toxicity study (Embryo-Fetal Developmental Study, EFD)
· Multi-generational breeding experiment
· Young animal studies supporting pediatric drug safety evaluations
· Male reproductive function
· Sperm count; sperm motility; sperm morphology; histopathology
· Evaluation of lactation and placental transport
· Neurobehavioral assessment
Motor behavior; learning and memory assessment
· Spontaneous Activity Assessment
· Assessment of growth and development as well as reflex functions
Growth hormone and insulin-like growth factor I testing; bone density and bone mass assessment; morphological differentiation; sexual differentiation; reflex function
· Bone development assessment
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