The main objective of pharmacokinetics studies is to study the routes of administration, distribution and metabolism of drugs in the body, as well as their elimination (metabolism and excretion).
Determination of pharmacokinetic properties of a pharmacological preparation enables to justify the choice of routes and methods of its administration, to identify the tissues into which it is distributed most intensively and / or in which it is retained for longest, to determine the main routes of elimination of a pharmacological preparation.
Pharmacokinetic data are needed to determine the “concentration / effect” relationship which can be used to predict the effects of the pharmacological agent in humans. These data also enable to optimize the choice of dosage form.
The results of these studies are mandatory for new drugs containing a single active ingredient or a combination for their subsequent registration. The results of pharmacokinetics studies are used to justify dosing regimens of the drug under development, which are subsequently refined in clinical studies.