Pre Clinical Development

Toxicity and Safety

SERVICES/CAPABILITIES

Primary and secondary pharmacology:

ChemDiv provides clients access to multiple animal models and has broad experience in evaluating all aspects of safety pharmacology. In addition, toxicological studies including genetic and reproductive studies can be conducted for our clients. With preclinical efficacy evaluations performed at CDRI, at our secondary sites in Russia and Ukraine and through our sub-contractors in the US and Europe(acute, subacute, subchronic and chronic)

  • Genetic Toxicology
  • Reproductive and developmental toxicology
  • Safety pharmacology

 

GENERAL TOXICOLOGY

  • Acute, sub-chronic, and chronic toxicology
  • Animal models using rats, mice, rabbits, dogs, non-human primates, ,
  • Experience with all classes of compounds, including pharmaceuticals, recombinant proteins and other biotech products,
  • Studies that are fully supported for formulation development and analysis, and complete toxicokinetic analysis

The toxicologists and study monitors at ChemDiv have experience in a variety of compounds and therapeutic areas. Our nonclinical resources are dedicated to getting the project to first-in-man studies. We place and monitor studies; obtain competitive bids with comparisons based on critical milestones; and design and review study protocols, considering dose selection, animal models, regimen, overall design and regulatory compliance.

 

GENETIC TOXICOLOGY

Background: The Ames test or Bacterial Reverse Mutation test is a biological assay to assess the mutagenic potential of chemical compounds. As cancer is often linked to DNA damage, the test also serves as a quick assay to estimate the carcinogenic potential of a compound since the standard tests for carcinogenicity done on rodents take years to complete and are expensive to do.