Target Animal Safety

Sinclair Research has a long history of evaluating the efficacy of test articles for human and animal health in a number of therapeutic areas, including nutrition, obesity, diabetes, cardiovascular, wound healing, osteoporosis, ocular, dermal, antibiotics, vaccines, analgesics/anesthetics and parasite control.

Sinclair conducts target animal safety (TAS) studies for animal health clients submitting master files supporting veterinary products INADAS, NADAS, and ANADAS to the FDA’s Center for Veterinary Medicine.

Special Capabilities

  • The majority of our TAS studies are feline and canine studies
  • We offer large in-house colonies of non-naive dogs and cats, and we are Class A suppliers of naive animals
  • Housing and Standard Operating Procedures are available for the following species:
    • Goats
    • Horses
    • Poultry
    • Sheep
    • Cattle
    • Rabbits
    • Ferrets

NADA Technical Sections – Requirements, In Part:

  • Effectiveness
  • Target animal safety studies
  • Human food safety (tissue residue depletion)

Sinclair can demonstrate effectiveness by well-controlled studies:

  • Efficacy studies in a target species
  • Bioequivalence studies (efficacy versus blood level)
  • Laboratory animal studies

Target animal safety and human food safety:

  • Pilot dose escalation studies
  • Tolerance studies
    • Acute administration
    • Long-term administration
    • Maximum tolerated dose (MTD) studies
  • Toxicity studies
  • Margin of safety in the target animal
  • Drug residues
    • Total residue and metabolism study
    • Tissue residue depletion
    • Residue determination after topical applications
  • Special studies
    • Reproductive safety studies (DART, neonatal swine capability)
    • Injection site irritation
    • Animal class safety studies (pediatric, geriatric)
  • Toxicology for human safety
    • 90-day feeding studies
    • One-year (chronic) feeding studies
    • One-year (chronic) feeding studies

 

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