Toxicity studies
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Toxicity studies

Toxicity studies of pharmacological substance are required to determine the nature and severity of its damaging effect on the organism of experimental animals and to assess its safety.

The main types of Toxicity studies:

  • acute toxicity study,
  • subacute and chronic toxicity study,
  • assessment of the overall condition of the animals,
  • total and complete blood count,
  • evaluation of the functional state of liver and kidneys,
  • electrocardiographic examination
  • cumulative effects study,
  • study of cognitive functions in experimental animals,
  • histopathological examination of the internal organs,
  • local tolerance studies ,
  • allergenicity, immunotoxicity, embryotoxicity and teratogenicity studies,
  • mutagenicity and carcinogenicity studies of drugs
  • comparative microbiological evaluation of antibacterial drugs

Toxicity study implies the research of pathological changes in the body resulting from acute and chronic toxic effects of drugs. As toxicity study directly in the human body is not always possible and sometimes is ethically unacceptable, toxicity studies are conducted in laboratory animals according to predefined preclinical studies protocol , then interpretation and extrapolation of available experimental data onto the human pathology in clinical toxicology are possible. Toxicity studies in animals enable to evaluate the development of pathological processes on cellular, subcellular, organ and systemic levels, and this comprises part of development of the drug.

Based on the study results, the decision on the possibility of using the active substance as a medicine is made, the maximum and minimum toxic doses are determined, safety criteria and potential side effects are defined.

Toxicity studies are conducted in specialized laboratories compliant with the requirements of Russian legislation. Mice, rats, dogs are used as experimental animals.