Developmental and Reproductive Toxicology (DART)

Fig.1 Potential effects of pharmaceutical drugs on the male reproductive system.¹

To provide a comprehensive suite of developmental and reproductive toxicology (DART) studies for the progression of pharmaceuticals and biopharmaceuticals, Creative Biolabs offers DART solutions including male and female fertility, developmental toxicity studies to evaluate the potential safety effects of the candidate drug or therapy on the full spectrum of development and reproduction.

DART Service

Creative Biolabs offers one-stop DART services, ranging from program planning and individual study design to study implementation, in full compliance with international regulatory standards, including ICH and OECD. The scope of our services includes pharmaceuticals (small and large molecules), and biopharmaceuticals (cellular and gene therapy, vaccines).

We are dedicated to providing studies about male/female fertility and developmental toxicity, including embryo-fetal development, pre/postnatal development, and multigenerational development, to evaluate the potential safety risks associated with novel therapies on the entire development and reproductive spectrum.

Our Capabilities

• ✔ Fertility and Early Embryonic Development
• ✔ Embryo Fetal Development
• ✔ Prenatal and Postnatal Development
• ✔ Enhanced Prenatal and Postnatal Development
• ✔ Juvenile Toxicity Studies
• ✔ Functional assessments, including growth (and the skeleton), pulmonary, neurobehavioral, reproductive and immunological development
• ✔ Special Developmental and Reproductive Toxicology Studies

Functional Assays of Evaluation

• ✔ Hormone assays
• ✔ Male reproductive assessments in rodents and nonrodents
• ✔ A variety of behavioral tests (such as activity and learning and memory) for prenatal and postnatal and multigenerational studies
• ✔ Range of developmental immunological tests
• ✔ Endocrine disruptor screenings (in vivo and in vitro)
• ✔ Skeletal measurements (such as bone size, geometry and density) for prenatal and postnatal studies using micro-CT, pQCT, X-ray and DXA

Animal models: a full range of rodent and nonrodent species are available to fit your program.

Routes of administration: dose routes ranging from dermal infusion to intravenous infusion.

Highlights

• ✔ The global capacity and expertise to cover all DART studies;
• ✔ Get your DART studies started faster;
• ✔ Integrated with the latest technology and techniques.

Creative Biolabs offers comprehensive, state-of-the-art DART services to help our clients make smarter decisions faster. We are dedicated to pioneering advances in DART studies to move your program into IND approval. Please contact us for more detailed information.

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