Preclinical studies of pharmacokinetic parameters of substances in in vitro systems (ADME)
In vitro studies serve as a screening method for assessing the role of biotransformation in the pharmacokinetics of drugs. These studies should precede the corresponding in vivo studies in humans, and are necessary for the preparation of the registration dossier.
The study of the pharmacokinetic parameters of the substance (original compounds) in in vitro systems (ADME) lets assess the elements of absorption, distribution, metabolism and elimination and, in some cases, to reduce the volume of studies using laboratory animals. Research is carried out in accordance with the recommendations of the FDA, EMA, ICH and OECD.
We conduct the following in vitro pharmacokinetic studies:
- determination of bound and free fraction of the tested compound in human blood plasma
- study of the stability of the test compound in the microsomal fraction of human liver
- estimation of permeability on the Caco-2 model
For the successful implementation of work on the study of pharmacokinetics in vitro:
- a design and a detailed research plan will be developed;
- appropriate in vitro experiments will be carried out;
- the analytical method will be validated in accordance with the recommendations of current domestic and foreign guidelines;
- the calculation of the corresponding parameters will be carried out.