Non-GLP Toxicity Studies

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

We can assist with:

• 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

Animal Species

• Rodents (rat and mouse)
• USDA regulated animals (guinea pig, hamster, ferret and rabbit)

Drug Administration Routes:

• IP, IV, IM, SC, PO
• Arterial
• 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)

Assessments

• In-life clinical observations
• Sample collection for clinical chemistry, hematology, urinalysis, etc.
• GLP-grade necropsy (up to 35 organs collected)
• Histopathology

Explora can manage the entire toxicology study from drug to report, with a rapid turnaround time and high quality results.