Preclinical Safety

Hamner staff have several years of expertise in performing preclinical safety studies.

The Hamner provides a wide range of capabilities to support safety studies required to bring new drugs and chemicals to the market. Our staff has extensive experience performing toxicity testing of drugs and environmental chemicals, carcinogenicity studies, inhalation exposures and characterization studies, and health effects research on nanomaterials.

The Hamner can perform acute to chronic toxicity studies via many routes of administration including inhalation, gavage, diet, and drinking water. Our AAALAC-accredited animal facility is strictly controlled to maintain a pathogen-free environment for our research animals. The facility is designed for flexibility and staffed by experienced animal care technicians responsible for dosing animals, recording clinical observations, and carrying out a variety of other procedures as well as performing routine husbandry duties. Automated data collection software allows electronic data collection in a GLP environment.

The Hamner’s Good Laboratory Practice (GLP) program includes established capabilities and systems to ensure data quality and integrity.  The Hamner’s Quality Assurance (QA) group conducts independent monitoring for GLP compliance for studies being conducted under EPA regulations/guidelines.


Specific Hamner capabilities include:

Toxicology

• Acute, Subchronic, and Chronic toxicity

• Toxicokinetics and Pharmacokinetics

• Carcinogenicity Bioassay

Mode-of-Action Studies and Risk Assessment

• Combine functional genomics, cell proliferation, and histopathology evaluations of target tissue responses

• Develop PB/PK and PB/PD models for tissue dosimetry and cellular responses

• Integrate experimental and modeling data into risk assessment