Preclinical studies

Drug development process is very long and laborious. It includes a lot of trials in a preclinical research center which are indispensable for the emergence of the drug on the market. Preclinical studies of drugs are the basis for further clinical trials.

Мышь в противогазеThis stage includes determination of:

  • general toxicity;
  • reproductive toxicity;
  • teratogenicity;
  • allergenicity;
  • immunotoxicity;
  • pharmacokinetics;
  • pharmacodynamics;
  • mutagenicity;
  • carcinogenicity.

Preclinical studies in animals are carried out to minimize adverse reactions while testing in humans. These studies give us an opportunity to determine the indications for drug use, contraindications and adverse effects, to understand the scope of further clinical trials and possibility of their conduction.

Features of preclinical studies of drugs

The study of original drugs includes determination of general and specific toxicity, pharmacodynamics and pharmacokinetics. While conducting preclinical studies of drugs-generics, we confine ourselves to investigate their general toxicity and pharmacokinetics (in several cases additional studies may be needed).

In addition, in the stage of preclinical studies we may determine the dose-dependency of drug effects. Preclinical studies in animals give us an opportunity to find out the highest possible safe dose and the feasibility of its increase. Preclinical studies are necessarily accompanied by a detailed report about all important aspects of the research work including information about the animals, ways of drug administration, tested concentrations, and data analysis of study results. In the stage of preclinical studies supposed doses are also explained for further clinical trials.

Experimental pharmacology