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Developmental & Reproductive Toxicology

WIL Research is uniquely qualified to assess the potential of pharmaceuticals (conventional, biotechnological, rationally designed) and agricultural and industrial chemicals to adversely affect development and reproduction. This expertise is especially important given the inherent difficulties of estimating human risk from experimental animal data. And it requires an advanced understanding of the dynamics of development and the complex physiology underlying the integrated reproductive systems based on gender and species.

Through sustained participation in the disciplines of developmental and reproductive toxicology, WIL Research has developed comprehensive historical control databases in several animal models. These databases, in combination with stable technical and experienced senior scientific personnel, can provide guidance for successful execution of non-clinical laboratory studies, timely regulatory submissions and can assist with requirements in risk assessment and product development programs.

Capabilities

• Good Laboratory Practice (GLP) compliant
• ICH, EPA, FDA, OECD, EU, MAFF, MITI, MHLW experience
• Complete range of study designs
• Fertility (ICH 4.1.1)
• Pre - and post natal development (ICH 4.1.2)
• Embryo-fetal development (ICH 4.1.3)
• Multigenerational studies
• Comprehensive historical control databases for both summarized presentation and by individual project
• Developmental toxicology
• Reproductive toxicology
• Postnatal developmental indices
• Routine and specialized routes of administration to include:
• Oral
• Inhalation
• Continuous infusion
• Diet and drinking water
• Subcutaneous
• Intravenous
• Percutaneous
• Dermal
• Vaginal
• Rectal

Evaluation Techniques

• Neurobehavioral testing
• Reproductive assessment by continuous breeding (RACB) assay
• Spermatogenesis evaluations of cellular endpoints via HTM-IVOS CASA system
• Motility
• Morphology
• Concentration
• Pharmacokinetics, pharmacodynamics, toxicokinetics
• Amniotic fluid
• Milk collection
• Fetal tissue
• Fetal blood
• Parental/maternal plasma samples
• Screening Informational Data Sets (SIDS)
• Fetal Evaluations
• Endocrine Screening
• Weight of evidence analysis
• Histopathology
• Male reproductive histopathology, including testicular staging
• Female reproductive histopathology including estrous

Special Services

• Consulting
• Special projects in support of litigation
• Custom risk assessment projects