Obtaining high quality non-GLP toxicology data in the early stages of developing a new drug is a critical and cost-effective step in guiding a subsequent GLP toxicology program.
Explora’s research team has:
- Experience in the safety assessment of small molecules and biologics, including dosing, in-life observations, sample collection, and necropsy
- Established IACUC protocols for toxicology studies in small animals
- Strong working relationships with clinical labs, histologists and pathologists
- Custom study design
- Complete study management
- GLP-style report generation (certain of Explora’s non-GLP toxicology study reports have been submitted to FDA in support of IND filings)
- On-site technical support and training
- Rodents (rat and mouse)
- USDA regulated animals (guinea pig and hamster)
Drug Administration Routes:
- IP, IV, IM, SC, PO
- Continuous infusion using mechanical or osmotic pumps
- Nasal mucosa, nasal cavity or tracheal/ bronchial (including aerosol inhalation)
Maximum Tolerance and Safety Studies
- Maximum Tolerated Dose (MTD)
- Dose Range Finding (DRF)
- Acute Toxicology
- Sub Chronic Toxicology (repeated dose)
- In-life clinical observations
- Sample collection for clinical chemistry, hematology, urinalysis, etc.
- GLP-grade necropsy (up to 35 organs collected)
Explora can manage the entire toxicology study from drug to report, with a rapid turnaround time and high quality results.