Pharmacokinetics, toxicokinetics, bioequivalence

The study of the pharmacokinetics of drugs is a mandatory step for implementation in clinical practice. In accordance with the rules for registration and examination of drugs for medical use (Decision of the EEC Council dated 03.11.2016 No. 78), the data of pharmacokinetic studies must be submitted in the registration dossier.

We offer services for the study of the pharmacokinetics of drugs at different stages of the life cycle:

  1. Preclinical studies of pharmacokinetics:
  1. Preclinical toxicokinetic studies 
  2. Study of bioequivalence of drugs in clinical trials (analytical part) 

The study of pharmacokinetics is carried out in accordance with the requirements of the regulatory authorities of the Russian Federation and international GLP rules.

Analytical methods

To carry out pharmacokinetic and toxicokinetic studies, we develop and validate a method for the quantitative determination of an analyte in various biological samples (plasma, urine, feces, organs), providing the possibility to reliably track the concentration of a pharmacological agent in biological samples.

We have experience in the development and validation of analytical and bioanalytical methods for a wide range of analytes.

For the analysis of biological samples, we develop methods using high-performance liquid chromatography (HPLC), high-performance thin-layer chromatography (HPTLC), enzyme-linked immunosorbent assay (Elisa), enzymatic methods.

Validation of analytical methods is carried out in accordance with the recommendations of current domestic and foreign guidelines for the following indicators: selectivity, lower limit of quantitation (LLOQ), calibration range, accuracy, precision.