Developmental and Reproductive Toxicology
Creative Animodel offers preclinical services focusing on pharmacokinetic and safety evaluation to worldwide clients. We perform a variety of in vitro toxicity assays under strict GLP and GMP compliance with FDA and EPA guidelines. With high-level scientific expertise and abundant resources, our team provides developmental and reproductive toxicology assays to help evaluate the potential compound-related effects on fertility, reproduction and pre/post-natal development.
Why In Vitro Developmental and Reproductive Toxicology Assays?
chemical or biological drug may have on sexual function and fertility in adult males and females, developmental toxicity in the offspring, as well as effects on, or mediated via, lactation. Thus, reproductive toxicity refers to a range of endpoints relating to the impairment of male and female reproductive capacity (fertility) and the induction of non-heritable harmful effects on the progeny (developmental toxicity). The variety of observable effects are brought about by a plethora of mechanisms of action, many of which are unknown or only partially understood at the molecular and cellular level. Along with carcinogenicity studies, DART studies are among the most costly and time-consuming experimental procedures. Furthermore, DART testing requires the highest number of test animals. For all these reasons, the development of alternative methods for DART assessment is a high political priority.
In vitro DART model systems have been an important tool for advancing basic research in the embryology and teratology fields. The rodents and zebrafish embryo models have had broad utility in both fields for many decades. Furthermore embryonic stem cells, applied as a basic research tool, have broad applications across the development fields and many other fields including cancer, regeneration and epigenetic research. These models have historically been applied in mechanistic studies but are also considered promising for evaluating teratogenic potential of test substances.
Our DART Services
Creative Animodel has made much progress in generating in vitro alternative approaches for supporting reproductive safety assessment of test compounds. We provide a less expensive and higher throughput in vitro DART tests to assess potential toxicity of compounds. Our alternative DART services include:
• Zebrafish embryo toxicity assay
• Sperm motility test
• Sperm morphology and staging assay
• Substantial scientific expertise and specialized resources
• A range of specialized functional evaluations
• Nonclinical testing of drug substances compliance with FDA, EMA and OECD guidance
• The flexibility and expertise to develop customized services tailored to customers’ special needs
Creative Animodel offers overall in vitro and in vivo DART program planning and individual study design to conduct safety assessments for your products under the regulatory guidelines. Our DART team brings together board-certified pathologists, general toxicologists and inhalation toxicologists in developmental, reproductive and endocrine toxicology for an integrated toxicology approach. As your partner, we consult with you on fit-for-purpose study design to keep your DART program on track.