Developmental and Reproductive Toxicology | SRI International
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Developmental and Reproductive Toxicology

SRI’s Developmental and Reproductive Toxicology (DART) Program provides a full spectrum of pharmaceutical safety evaluation services, including studies to support preclinical development. All services are designed to comply with regulations, including Good Laboratory Practices.

Related Services

Standard ICH S5(R2) Studies

  • Fertility and early embryonic development to implantation—
    Sec. 4.1.1, Segment I

  • Embryo-fetal prenatal development—Sec. 4.1.3, Segment II

  • Perinatal and postnatal development, including maternal function—
    Sec. 4.1.2, Segment III

    • Dose range-finding studies

    • Multigenerational dosing studies

  • Toxicity to male fertility—ICH S5(R2) part 2

Fertility, Anti-fertility, and Contraception Studies

In Vitro Screens

  • 3β-Hydroxysteroid dehydrogenase activity

  • D5-3-Ketosteroid isomerase activity

  • Progestagenic and anti-progestagenic activity

  • Uterotrophic and anti-uterotrophic activity

  • Androgen, estrogen, progesterone receptor binding

In Vivo Studies

  • Spermatostatic contact

  • Sperm motility and cytokine induction

  • Clauberg-McPhail endometrial proliferation

  • Androgenic assay

  • Antigonadotropin assay

  • Oocyte antimeiosis assay

  • Sperm motility and morphology assay

Evaluation Endpoints

  • Standard toxicology study routes and endpoints

  • Fetal evaluations

  • Spermatogenesis evaluations

  • Neurobehavioral evaluations

  • Sensorimotor evaluation in F1/F2 neonates and juveniles

  • Pharmacokinetics, pharmacodynamics, toxicokinetics

  • Immunogenicity/antibody levels

  • Immunotoxicity

  • Cytokine levels

  • Drug levels in plasma, tissues, fetus, pups, milk

  • DNA/RNA biodistribution, persistence, integration



scientist looking through a microscope

Toxicological Evaluation of Novel Ligands Program

For the National Institute of Mental Health (NIMH), SRI performs preclinical safety and pharmacokinetics studies for brain imaging agents and drugs to treat mental illnesses.