Developmental & Reproductive Toxicology

Flexible Study Designs

Our Development and Reproductive Toxicology (DART) studies and services assess the reproductive safety of your drugs, chemicals or pesticides after repeated or chronic exposure. Our Safety Assessment team provides Investigational New Drug (IND)- and New Drug Application (NDA)-enabling DART studies in mice, rats and rabbits. We offer flexible, fully customized study designs for Segment I, II and III assessments.

Our Services Include:

• Dose-range-finding study on embryo-fetus development in mice, rats and rabbits
• Fertility and early-development-to-implantation studies in mice and rats (Seg I)
• Definitive embryo-fetus development study in mice, rats and rabbits with TK (Seg II)
• Fetal/neonatal, peri/postnatal development studies in rats (Seg III)

Species

• Rat
• Mouse
• Rabbit
• NHP

Dosing Route

• Oral gavage
• Dermal
• SC injection
• IM injection
• IV injection, IV infusion (up to 1 h)
• Vaginal route
• Penile route

Capabilities and Services

Fertility and Early Embryonic Development (FEED) study (Seg I)

• Dose-range-finding study on FEED in mice and rats
• Definitive FEED study in mice and rats (Combined Design/Separate Sex Design/Combined Male Fertility in Repeat Dose Toxicology Design)

Embryo-Fetal Developmental (EFD) Study (Seg II)

• Dose-range-finding study on EFD in mice, rats and rabbits
• Preliminary EFD (pEFD) study in mice, rats and rabbits (optional)
• Definitive EFD study in mice, rats and rabbits (single or double staining)
• Drug concentration measurement in fetal blood (if needed)
• SEND data sets for EFD study

Pre- and Postnatal Development (PPND) study (Seg III)

• Dose-range-finding study on PPND in mice and rats (if needed)
• Definitive PPND study in mice and rats
• Drug concentration measurement in milk (if needed)
• Drug concentration measurement in pup blood

Juvenile Animal Study Capabilities

Routine Study Types

• Tolerability/MTD Study
• Dose-range-finding Study
• Definitive Study (usually 1-3 months)

Species

• Rodents: Rat (most common), Mouse (alternate)
• Non-rodents: Dog, Minipig, NHP