Developmental and reproductive toxicology

Developmental and reproductive toxicology

Developmental and reproductive toxicology (DART) studies are an important part of drug and chemical safety evaluation (ICH M3, S5, S6 and OECD 421, 422, 443, 414, 415, 416). Our DART department has extensive experience in providing a full suite of reproductive and developmental toxicity tests that meet the requirements of the U.S. FDA, U.S. EPA, ICH, OECD, and CFDA guidelines. All tests were conducted in compliance with international GLP regulations. The historical reference database accumulated over many years, the stable technical team and the professional senior researchers ensure that we can provide high-quality services to our customers in a timely and efficient manner.

Category: Non-clinical safety evaluation

Medicines for human purposes

Developmental and reproductive toxicology (DART) studies are an important part of drug and chemical safety evaluation (ICH M3, S5, S6 and OECD 421, 422, 443, 414, 415, 416). Our DART department has extensive experience in providing a full suite of reproductive and developmental toxicity tests that meet the requirements of the U.S. FDA, U.S. EPA, ICH, OECD, and CFDA guidelines. All tests were conducted in compliance with international GLP regulations. The historical reference database accumulated over many years, the stable technical team and the professional senior researchers ensure that we can provide high-quality services to our customers in a timely and efficient manner.

Fertility and Early Embryonic Development Toxicity Test (Seg I)

· Embryo-Fetal Developmental Toxicity Test (Seg II)

· Perinatal developmental toxicity Test (Seg III)

· Enhanced Pre-and Postnated Developmental Study (ePPND) in cynomolgus monkeys

· Embryo-Fetal Developmental Study (EFD)

· Multi-generation breeding test

· Support juvenile animal tests for pediatric drug safety evaluation

· Male reproductive function

· Sperm count; Sperm motility; Sperm morphology; histopathology

· Evaluation of milk secretion and placental transport

· Neurobehavioral tests

Motor behavior; Evaluation of learning and memory

· Evaluation of spontaneous activity ability

· Growth, development and reflex function detection

Growth hormone and insulin-like growth factor I detection; Bone density and bone mass testing; Appearance differentiation; Gender differentiation; Reflex function

· Bone development evaluation