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Developmental and Reproductive Toxicology (DART)

Make safer, faster decisions with human relevant screening and full in vivo programs - now including devTOX quickPredict™
Developmental and Reproductive Toxicology (DART)

Plan your DART pathway with confidence

Make faster, clearer decisions with integrated in vitro NAMs, GLP in vivo studies in small and large animals, and specialized nonhuman primate (NHP) capabilities. Our senior DART scientists align study design, endpoints, and timelines with your regulatory strategy—reducing surprises and strengthening data packages.

70+

small-model DART studies conducted annually

120+

pregnant NHP studies and 25+ e(P)PND programs completed

Expert-led

dedicated neurobehavioral science support

Welfare‑driven

stable, enriched rodent and rabbit facilities

Social housing standard

with EU‑compliant housing and enrichment across key sites


Learn more about our Culture of Care

Early, human-relevant insight with devTOX quickPredict™

devTOX quickPredict provides rapid, human‑relevant developmental toxicity insight using a pluripotent stem‑cell assay and the quantitative ornithine/cystine ratio (O/C) metabolic biomarker. It supports early candidate prioritization and stronger weight‑of‑evidence packages while aligning with ICH S5(R3) to inform, defer, or replace one of two required species in EFD studies.

You gain

  • Quantitative exposure‑based thresholds

  • Human‑relevant metabolic insight

  • Clear early screening signals

  • Support for reduced‑species EFD strategies under ICH S5(R3)

Your DART program, supported end‑to‑end

Labcorp’s integrated pathway supports early NAM insights to directly inform downstream study design, reducing handoffs, and accelerating IND-enabling plans.

Early screening: Human relevant developmental toxicity

Gain early insight into developmental toxicity with devTOX quickPredict, a human pluripotent stem‑cell assay that measures metabolic shifts using the O/C biomarker.

Quantitative, exposure‑based thresholds help prioritize candidates or substances and guide downstream DART planning before in vivo studies

SEG I: Fertility & early embryonic development

  • External genitalia evaluation
  • Reproductive organ exams and performance
  • Biochemical and hormonal parameters
  • Sperm motility, morphology, and staging
  • Estrus and menstrual cycle determination
  • Testis volume and biopsy
  • Prostate volume and biopsy in NHPs
  • Standard rodent and rabbit reproductive endpoints, including estrus cycle staging, sperm assessment, and reproductive organ evaluations
  • ICH S5(R3) aligned NAM devTOX quickPredict™ NAMs to inform or defer in vivo studies and reduce EFD species.

SEG II: Embryo fetal development

Your SEG II study is pivotal for regulatory labeling. We provide:

  • Deep expertise in teratology and fetal evaluation
  • An expansive in‑house historical control database
  • Assessment of external, visceral, and skeletal anomalies
  • Fetal observations and pathology
  • Amniotic fluid and fetal blood collection/analysis
  • Neurobehavioral endpoints supported in rodents, rabbits, and NHPs

SEG III: Pre-natal and post-natal development

Access the expertise and resources needed to evaluate juvenile neurobehavioral endpoints in NHPs, rodents, and rabbits, including:

  • Sensory and motor reflexes
  • Motor activity
  • Learning and memory
  • Sexual maturation and reproductive performance

Enhanced pre natal & post natal development (ePPND)

Evaluate functional consequences of mid‑to‑late gestational exposure with optimized study designs that use fewer NHP models. This is particularly valuable for biologics such as monoclonal antibodies.

Juvenile studies

Pediatric safety assessment now carries significant regulatory expectations. Labcorp provides:

  • Guidance on species selection and husbandry
  • Expertise in endpoint selection
  • Logistical and scientific support for these complex study designs

We help determine the most appropriate, cost‑effective, and socially responsible study design before you begin.

Advanced techniques that strengthen every DART study

Infusion & specialty techniques

Implement advanced techniques across species—including challenging reproductive and developmental models—with specialists focused on accurate delivery, minimal stress, and high‑quality data.

Core capabilities: Intravenous bolus/continuous infusion, SC/IP microinfusion, programmable/osmotic pump implantation, maternal surgical support (e.g., catheterization, automated dosing), neonatal/juvenile dosing, and precise dose placement in sensitive developmental windows.

TLE automation machine

GLP-compliant microCT imaging

This provides high‑resolution, nondestructive evaluation of fetal morphology and skeletal development in rodent and rabbit models, with optional NHP applications. High-resolution images enhances classical teratology endpoints by enabling rapid 3D assessment, quantification of subtle changes, and comprehensive skeletal/soft‑tissue visualization while preserving samples.

Provider and patient sitting on a couch with pill bottles and a tablet on a table. The meeting is inside the patient's home

Neurobehavioral expertise

Dedicated in‑house neurobehavioral science provides consistent methods, scientific rigor, and deeper interpretation across juvenile and PPND programs—covering cognitive development, reflex/sensory maturation, motor coordination, and behavioral phenotypes across developmental stages.

Young woman standing in a hallway with a laptop in her hand


 

Additional services to support your drug development journey

DART educational resources

Frequently asked questions (FAQ)

Ready to advance your DART strategy?