Developmental and Reproductive Toxicity (DART)
Reproductive development studies are essential components of the safety assessment for new drugs. With years of accumulated rich control data and a professional and stable research team, JOINN’s reproductive development toxicity research department can provide clients with a full set of reproductive and developmental toxicity evaluation studies that meet the requirements of the U.S. FDA, U.S. EPA, ICH, OECD, and China NMPA guidelines.
Service Content
Reproductive Toxicology Service Content
Fertility and early embryonic development toxicity studies (Seg. I, mice, rats, rabbits)
Embryo-fetal development toxicity studies (Seg. II, mice, rats, rabbits, non-human primates)
Pre- and Postnatal development toxicity studies (Seg. III, mice, rats, rabbits)
Enhanced pre- and postnatal toxicity studies (ePPND, non-human primates)
Developmental toxicity screening studies
Sperm morphology studies
One-generation and multi-generation reproductive toxicity studies
Breeding studies
Developmental neurotoxicity studies
Developmental immunotoxicity studies
Sexual function detection
Small for gestational age (SGA) model
Whole embryo culture method—early in vitro screening of drugs
Animal Species
Rodent animals
Rats (SD, Wistar)
Mice (ICR, KM, C57BL/6, transgenic mice)
Non-rodent animals
Rabbits (New Zealand White, Japanese White)
Non-human primates (Crab-eating macaques)
Service Advantages
Extensive experience in standard reproductive and developmental toxicity evaluation tests (Seg. I, Seg. II, and Seg. III), with evaluation of various types of drugs including small molecules, biologics, small nucleic acids, and gene therapy products.
The design of combined reproductive and developmental toxicity evaluation experiments for vaccines has been reviewed and approved multiple times by domestic and FDA authorities.
Established the first evaluation model for embryonic-fetal developmental toxicity testing in cynomolgus monkeys in China, and completed several GLP ePPND tests in cynomolgus monkeys for new drug registration applications.
Rich experience in the application of surrogate molecules and transgenic animals in the reproductive and developmental toxicity evaluation of biologics.
Extensive experience in reproductive and developmental toxicity testing in rabbits, including Seg. I, Seg. II, and Seg. III, and with proficiency in artificial insemination techniques in rabbits.
A mature in vitro whole embryo culture method for screening early drug developmental and reproductive toxicity.
A standard GLP laboratory, a professional technical team, a comprehensive technical platform, and extensive evaluation experience.
