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Developmental and Reproductive Toxicology

SRI’s Developmental and Reproductive Toxicology (DART) Program is an integral part of our pharmaceutical safety evaluation services. We can offer you the full spectrum of GLP regulatory-compliant DART studies to complement any preclinical development package.

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

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     Last Updated Aug 28, 2009