Developmental and Reproductive Toxicology (DART) Services

Key Differentiators

• Direct Access to Experts: Hands-on guidance from PhD, DABT study directors
• Regulatory Alignment: Full compliance with ICH, OECD, FDA, EMA, and REACH guidelines
• Specialty Expertise: Inhalation and dermal routes, complex dosing regimens
• Integrated Support: Bioanalytical, clinical pathology, and immunology services in-house
• GLP-compliant facilities with large study capabilities
  
• Proven Track Record: Decades of experience and historical database
• Accreditations: AAALAC, USDA, NIH (OLAW), USDEA, CDC

Comprehensive Expertise for Regulatory Success

IITRI offers a full suite of Developmental and Reproductive Toxicology (DART) studies designed to meet global regulatory requirements and accelerate your product’s path to market. Our PhD, DABT study directors and experienced scientific team provide hands-on guidance from study design through execution, ensuring compliance and clarity for IND and NDA submissions.

STUDY Capabilities

ICH-Compliant Studies

• Segment I – Fertility and Early Embryonic Development (FEED) (ICH R5(R2))
• Segment II – Embryo-fetal Developmental Toxicity (EFD/Teratology) (ICH R5(R2))
• Segment III – Pre- and Post-Natal Reproductive Toxicity (PPND) (ICH R5(R2))

OECD Studies

• Reproduction/Developmental Toxicity Screening Test (OECD 421)
• Extended One-Generation Reproductive Toxicity (OECD 443)

Juvenile Safety and Toxicity Studies

Customized programs for pharmaceuticals, biologics, vaccines, chemicals, and agrochemicals

Species and models

• Rats, mice, rabbits, dogs
• Expanded capabilities: minipigs, ferrets, guinea pigs, and nonhuman primates (NHPs) upon request

routes of administration

• Oral, IV, IM, SC, dermal, ocular, inhalation
• Specialty expertise in inhalation and dermal studies

supporting labs and analyses

• Bioanalytical method development and optimization
• Clinical pathology
• Immunology endpoints (ADA, cytokines, flow cytometry)
• Histopathology
• Sperm analysis (IVOS)

IITRI Publications for dart programs

We have published two studies on the developmental toxicity in rats for an occupational exposure (inhaled building material fibers), and the fertility and embryofetal developmental toxicity of cytisine, a plant-based alkaloid used for smoking cessation in rats. See our peer-reviewed journal article list and posters and white papers pages for more information.