Toxicology

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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:Up_down_MTD_tree

  • 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 and hamster)

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.