Preclinical Services for Animal Health
Sinclair Provides Capabilities and Services for Animal Health Clients Submitting Master Files Supporting INADAs, NADAs, ANADAs to the FDA’s Center for Veterinary Medicine
Special Capabilities
- Felines
- Canines
- Large in-house colonies of non-naïve animals of dogs and cats, plus Class A suppliers of naïve animals
- Miniature Swine – Breeding Colony (Sinclair, Yucatan, Hanford)
- Housing and SOPs for the following species:
- Goats
- Sheep
- Rodents (Mouse, Rat, Hamster)
- Horses
- Rabbits
- Poultry
- Ferrets
- High Capacity for Small and Large Animals
NADA Technical Sections – Requirements, In Part
- Effectiveness
- Target animal safety
- Human food safety (Tissue Residue Depletion)
Sinclair can Demonstrate Effectiveness by Well-Controlled Studies
- Efficacy studies in a target species
- Laboratory animal studies
- Bioequivalence studies (Efficacy vs Blood Level)
Target Animal Safety and Human Safety (Food Animal Drug Residues)
Sinclair Capabilities:
- Pilot dose escalation studies
- MTD studies
- Tolerance studies
- 10X dose at max duration (acute administration)
- 21 days (long-term administration)
- Toxicity/margin of safety studies
- Toxicity studies in the target animal species
- Maximum dose with no adverse effects
- Margin of safety in the target animal
- Special Studies
- Reproductive safety studies (neonatal swine capability)
- Injection site irritation (injectables)
- Animal class safety studies (e.g., pediatric, geriatric)
- Drug Residues
- Total residue and metabolism Study
- Determine the marker residue
- Determine the target tissue
- Tissue residue depletion (muscle, kidney, liver, fat, milk, eggs)
- Objective: Run a residue depletion study under field conditions to determine how long it takes marker residues to deplete to below the tolerance.
- User safety – e.g., residue determination after topical applications
- Toxicology for Human Safety
- 90-day feeding studies
- One-year (chronic) feeding studies