Developmental and Reproductive Toxicology

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Developmental and Reproductive Toxicology 2017-07-04T10:25:32+00:00

MPI Research delivers substantial scientific expertise and specialized resources in the developmental and reproductive toxicology (DART) testing of pharmaceutical, biopharmaceutical products, chemicals and pesticides. We offer a broad range of customized DART services to test the safety of your compound and evaluate its effect on reproductive and developmental functions. Services include studies that identify pharmaceuticals, biologics, or chemicals that affect fertility and embryonic development, prenatal and postnatal development, and maternal function.

DART Capabilities

MPI Research provides

  • Industry-leading rodent/nonrodent study designs to assess fertility, embryonic development to implantation, fetal development, pre- and post-natal development, and maternal function, following regulatory guidelines, including International Conference of Harmonization (ICH), OECD guidelines, and FDA.
  • Expertise in juvenile toxicity testing in a wide range of species, using various routes of administration. Our studies conform to FDA, EMA, OECD, and MHLW guidance for nonclinical testing of pediatric drug products
  • Nonhuman primate DART testing for small molecules and biologics, including stand-alone male and female fertility or combined in a > 3-month repeated toxicity testing, embryo-fetal development, and enhanced pre- and post-natal development studies
  • DART testing for chemicals/pesticides that are potentially harmful during pregnancy and/or impact fertility. These studies encompass Organization for Economic Cooperation and Development (OECD) 414, 415, 416, 421, and 422
  • The flexibility and expertise to develop customized models tailored to individual Sponsor needs
  • Infant formula testing (piglet model)
  • Fertility and early embryonic development studies (rodent)
  • Pre- and post-natal development studies, including maternal function (rodent)
  • Embryo-fetal development studies (rodent, rabbit)
  • Neonatal and juvenile animal studies (various species)
  • Developmental neurotoxicology studies
  • Toxicokinetic evaluation
  • Maternal evaluations
    • Necropsy
    • C-sections
    • Uterine examinations
  • Post-life fetal evaluations in multiple species and strains
    • External morphology
    • Visceral
    • Skeletal
  • Neurobehavioral assessments
    • Motor activity
    • Learning
    • Memory
    • Acoustic startle response
  • Sperm assessments
    • Concentration
    • Count
    • Motility (using Hamilton Thorne IVOS Analyzer)
    • Morphology
  • A complete suite of developmental and fertility studies in cynomolgus monkeys with all necessary endpoints, including
    • Monitoring of menstrual and mating cycles
    • Dosing and handling of pregnant females
    • Use of ultrasound in determining pregnancy status and collecting key measurements such as fetal Heart Rate [HR], Crown-Rump Length [CRL], Bi-Parietal Diameter [BPD], Femur Length [FL], and other important aspects of fetal evaluation
    • C-section
    • Sperm collection and evaluation
    • Testes volume measurement
    • Blood collection for determination of hormone and test article concentration
  • In vivo specialty studies for endocrine-disrupting chemicals
    • Uterotrophic
    • Hershberger assays
    • Male and female pubertal assays
  • Technical staff proficient in test article administration
  • Route of Administrations
    • Oral gavage
    • Subcutaneous (including implants)
    • Intravenous
    • Dermal
    • Intramuscular
    • Intraperitoneal
    • Intravaginal
    • Intranasal
    • Dietary
    • Infusion