In Vivo Reproductive Toxicology
The regulatory agencies around the world including Food and Drug Administration (FDA) generally require developmental and reproductive toxicity (DART) testing of all new drugs to be used by women of childbearing age or men of reproductive potential. The studies are designed to identify the effects of drugs on mammalian reproduction, including exposure of mature adults, as well as all stages of development from conception to sexual maturity. Animal studies are unique in the assessment of reproduction and development as DART studies are not performed in controlled clinical trials; therefore, pre-clinical safety assessment forms the basis for risk assessment of marketed drug products.
Our In Vivo Reproductive Toxicology Services
In vivo reproductive toxicology services at Creative Animodel currently rely on animal testing to predict the potential of small molecules/ biologics or chemicals to cause developmental toxicity in humans. Rats, mice, and rabbits are the most relevant species used in DART testing. Our studies, like TK (toxicokinetic) evaluation in adult animals and pups, are conducted via different routes of administration. Our available in vivo reproductive toxicology services include:Spermatostatic contact studiesSperm motility and cytokine assaysClauberg-McPhail endometrial proliferation assaysAndrogenic and antigonadotropin assaysOocyte anti-meiosis assaysSperm motility and morphology assays
In addition, we also have a package of evaluation endpoints: Standard toxicology study routes and endpointsSpermatogenesis evaluationsNeurobehavioral evaluationsSensorimotor evaluation in F1/F2 neonates and juvenilesPharmacokinetics, pharmacodynamics and toxicokineticsImmunogenicity/antibody levelsImmunotoxicity and cytokine levelsDrug levels in plasma, tissues, fetus, pups and milkDNA/RNA biodistribution, persistence and integration
Creative Animodel's in vivo toxicology services department provides preclinical toxicology services based on all animal species for new drug and biologics. Our DART team brings together board-certified pathologists, general toxicologists and inhalation toxicologists in the field of developmental, reproductive and endocrine toxicology. We can also offer in vitro DART program planning to conduct safety assessments for your products under the regulatory guidelines. We will be pleasured to be your partner to make a contribution to human health. Look forward to working with you in the near future.
ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for medicinal products including toxicity to male fertility. 29 August 2017.