Reproductive and Developmental Toxicity Studies


SNBL Japan performs reproductive and developmental toxicity studies and associated studies using rats, mice, rabbits, cynomolgus monkeys, and rhesus monkeys. Most importantly, we are one of only a few facilities in the world with the capabilities to conduct reproductive and developmental toxicity studies using non-human primates. We can perform EFD (embryo-fetal development), PPND (pre- and postnatal development), and ePPND (enhanced PPND) toxicity studies of biotechnology-derived pharmaceuticals.

 

We have extensive background data, and the Japanese Teratology Society -approved Reproductive and Developmental Toxicologists at SNBL Japan will work to provide an appropriate protocol in reference to the relevant GLP regulations and guidelines. appropriate for your project.


 

Study Types and Duration

(initiation of study to submission of draft final report)

 

Effects on fertility and early embryonic development to implantation

  • Rats & Mice: 6 months

Effects on embryo-fetal development

  • Rats & Mice: 6 monthsRabbits: 7 months
  • Cynomolgus monkeys: 8 months (C-sectioning: GD100), 10 months (C-sectioning: GD140)

Effects on pre- and postnatal development, including maternal function

(including ePPND studies using cynomolgus monkeys)

  • Rats & Mice: 10 months
  • Cynomolgus monkeys: 16 months (until postnatal day 180), 22 months (until postnatal day 360)

We can also perform juvenile toxicity studies and testicular toxicity studies.

 

Methods of Administration Used in Reproductive and Developmental Toxicity Studies

  • Oral (intragastric administration through the nasal cavity) administration
  • Intravenous administration (including a 24-hour infusion by the indwelling catheter)
  • Intramuscular administration, subcutaneous administration

※ The following examinations can be performed in the dam, offspring, or fetus of cynomolgus monkeys.

  • Immunological examinations (T-cell dependent antibody reaction, immunophenotyping, immunohistochemistry, NK cell activities, delayed-type hypersensitivity reaction)
  • Behavior, and learning and memory examinations
  • Fetal and placental histopathology
  • Hormone concentration measurement
  • Drug concentration measurement in milk
  • In utero fetal growth examinations
  • Drug concentration and anti-drug antibody measurements in fetal blood or amniotic fluid