Preclinical Toxicology Testing Services

Preclinical toxicology and related safety studies are a pivotal part of the drug development life cycle. They are needed to demonstrate that the test compound is safe, and at what doses, for administration to humans as part of clinical trials. Start your safety and toxicology program with a strong strategy that anticipates issues and avoids costly delays.  

preclinical toxicology is essential to design safe and effective clinical trials

According to advise from the USFDA, The purpose of preclinical work–animal pharmacology/toxicology testing–is to develop adequate data to undergird a decision that it is reasonably safe to proceed with human trials of the drug” (FDA, Drug Development And Review). As such, these studies are absolutely critical to every IND development program.

 

 

Clinical trials are expensive and consequential. Well-designed preclinical toxicology can pre-empt potential hazards and provide key biological insights that guide development. We have explored these ideas in the context of medical devices in a white paper on the subject. 

Well designed preclinical toxicology studies begin with an understanding of which model is best suited to answer your question. Absorption Systems have extensive experience conducting toxicology studies that address:

  • Sub-acute and long-term/chronic toxicology
  • Specialised dose route or target compartments (e.g. ocular, dermal)
  • Developmental toxicology
  • Device and Safety Testing
  • GLP Preclinical Studies
  • IND Enabling Studies

 

The Absorption Systems Difference

Every program is unique. Our team’s extensive experience with toxicology studies, and their preparedness for unexpected issues, ensure your study will produce regulatory compliant data within efficient turnaround. From
pharmacokinetics through safety/tox assessments, Absorption Systems has the expertise and accredited resources to guide you through your pre-IND requirements and help expedite the decisions that move your compound forward with confidence. 

FREQUENTLY ASKED QUESTIONS

What species do you work with?

We have expertise and access to a range of species that serve as preclinical models. We understand which species are best suited to tackle different toxicology questions. Our species include:

  • Rats
  • Mice
  • Guinea Pigs
  • Rabbits
  • Dogs
  • Monkeys
  • Pigs, Minipigs
  • Sheep
  • Goats

 

What dose routes do you use?

Our scientists and veterinarians are adept in a range of common and specialist dose routes, including:

  • Intravenous
  • Oral
  • Intraperitoneal
  • Sublingual
  • Buccal
  • Transdermal
  • Intraduodenal
  • Subcutaneous
  • Intracolonic
  • Intramuscular
  • Intratracheal
  • Ocular

 

What endpoints do you measure?

  • Toxicokinetics
    • LC-MS/MS platform
    • Biodistribution and TK parameters
  • Clinical Pathology
    • Hematology
    • Coagulation
    • Clinical Chemistry
  • Histopathology (local and systemic)

OUR CAPABILITIES

  • GLP Preclinical Studies
  • IND Enabling Studies
  • Dermal Toxicology
  • Ocular Toxicology
  • Device and Safety Testing
  • TK/PK Screening
  • DRF and MTD Studies
  • Subacute and Chronic Tox

 

Our state-of-the-art facilities are fully compliant with all relevant regulations:

  • Rapid IACUC Turnaround
  • AAALAC Accredited
  • OLAW Assured
  • GLP Compliant
  • In-House Veterinarians
  • Board and Certified Veterinary Pathologists
  • Small and Large Animal Models
  • Alternate Dose Routes
  • Clinical Bioanalysis

TECHNOLOGIES AND METHODOLOGIES

We employ the latest technologies and methodologies in our toxicology testing:

  • Optical Coherence Tomography (OCT)
  • Electroretinography (ERG)
  • Fundus photography
  • Fluorescein Angiography
  • Intraocular Pressure (IOP)
  • Clinical Ophthalmic Examinations
    • Slit-lamp biomicroscopy & indirect ophthalmoscopy
    • Completed by a Board Certified Veterinary Ophthalmologist