In vivo preclinical pharmacokinetics studies

Obtaining the most complete information about the absorption, distribution, metabolism and elimination of the active substance at the stage of preclinical studies lets  determine the optimal routes of administration of the active substance, the optimal dosage form for the active substance, an indicative dosage regimen of the drug and  select the doses of the drug for phase I clinical trials.

A detailed study of the pharmacokinetics of the substance, as well as the study of the pharmacokinetics of the experimental compositions of the future drug at the stage of pharmaceutical development, lets create an effective drug with an optimal pharmacokinetic profile.

We conduct research on the pharmacokinetics of drugs at different stages of the life cycle.

  • study of the pharmacokinetics of substances
  • study of the pharmacokinetics of the experimental formulations of the developed drug;
  • study of the pharmacokinetics of original drugs (the study is performed on two species of animals)
  • study of the pharmacokinetics of generic drugs
  • study of the pharmacokinetics of combined drugs
  • study of pharmacokinetic interaction

We have extensive experience in conducting pharmacokinetic studies of both original and generic drugs. Related publications

For the successful implementation of work on the study of pharmacokinetics:

  • a design and a detailed research plan will be developed
  • appropriate in vivo experiments will be carried out on laboratory animals (mice, rats, rabbits, guinea pigs, dwarf pigs, dogs, cats, etc. (ссылка на раздел лабораторные животные)
  • a procedure for preparing a biomaterial test and quantitative determination of the active substance and / or metabolites in plasma / urine / organs and tissues will be developed
  • the analytical method will be validated in accordance with the recommendations of current domestic and foreign guideline
  • the calculation of pharmacokinetic parameters and their statistical evaluation will be carried out.