Developmental and Reproductive Toxicology Services

Standard or Customized Study Designs

• Fertility and Early Embryonic Development Studies for Male and/or Female (FEED, SEG I)
• Embryo-Fetal Development/Prenatal Developmental Toxicity Studies (EFD, SEG II)
• Prenatal Development and Postnatal Developmental Studies (PPND, SEG III, OECD 414)
• Combined 28-day Developmental and Reproduction Screening Test (OECD 421/422)
• Extended One-Generation Reproductive Toxicity Studies (EOGRTS, OECD 443)
• Male and Female Rat Pubertal Assays (USEPA Endocrine Disruptor Screening Program, OPPTS 890.1450/1500)
• Rat Hershberger Assay (USEPA Endocrine Disruptor Screening Program, OPPTS 890.1400, OECD 441)
• Rat Uterotrophic Assay (USEPA Endocrine Disruptor Screening Program, OPPTS 890.1600, OECD 440)
• Developmental Neurotoxicity Study (OECD 426)
• In Utero Exposure Phase for Addition to Carcinogenicity or Chronic Toxicity Studies (FDA Redbook 2000:IV.C.8)

Route of Administration

• Oral: Gavage, Dietary, Drinking Water
• Subcutaneous
• Intravenous
• Intramuscular

Species

• Mouse
• Rat
• Rabbit

Customized Study Designs

• Species selection and age for intended patient populations
• Consideration of timing of dosing, exposure, monitoring, pharmacological/toxicological differences

Route of Administration

• Oral Gavage
• Subcutaneous
• Intramuscular

Species

• Mouse
• Rat

Locomotor Activity

• Models ability to navigate environment and habituation

Startle Response

• Measures reflex due to a sudden stimulus for learning and habituation

Morris Water Maze

• Studies spatial learning and memory

Functional Observational Battery (FOB)

• Detailed observation to detect changes in central nervous system, autonomic nervous system, and neuromuscular functions

• FEED and Embryo-Fetal Development and Fetal Toxicity, (aka Seg I and Seg II): Clinical Phase II
• Juvenile Tox, EOG, PPND: typically, at Clinical Phase III; there can be exceptions based on the sponsor's needs

Any product in which pregnant women, women of childbearing potential, or children may be exposed.

Any product that may potentially have a pediatric indication.

• FEED: effects on production of gametes, mating, fertilization, and implantation
• EFD: embryogenesis, fetal toxicity and development, closure of the hard palate 
• PPND: effects on or during birth, lactation, sexual maturation of offspring
• Multigeneration studies such as the OECD 443 (EOGRTS) assess all phases of the reproductive cycle and the development of subsequent generations. Functional endpoints in offspring may include neurotoxicity and immunotoxicity, as needed, based on the test substance/article    

• For In-life: FEED: ~60 days; EFD: ~20-30 days depending on species (mouse, rat, rabbit); PPND: ~135 days
• OECD 443 (EOGRT): 6+ months; length can vary depending on the number of generations assessed