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:
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.
Publications on topic:
Kosman V.M., Karlina M.V. Residual protein content in the blood plasma biosamples of laboratory animals (rabbits) after their preparation for HPLC-UV analysis// Problems of biological, medical and pharmaceutical chemistry. – 2020, Vol.23(10). – P 53-58.
Kosman V.M., Faustova N.M., Urakova I.N., Karlina M.N., Makarov V.G. Dypeptydylpeptidase IV activity ingibition after oral administration to rabbits of Strongylocentrotus droebahiensis gonads extract as possible biomarker of pharmakokinetics. //Razrabotka i registratsiya lekarstvennykh sredstv = Drug development & registration. – 2020, № 9(3). – P. 158-165.
Kosman VM, Karlina MV, Makarova M.N. Experience in development of bioanalytical methods by HPLC with UV detection// Farmaciya= Pharmacy. – 2020, Vol. 69(3). – P. 23-35.
Kosman VM, Karlina MV, Pozharitskaya ON. Effect of sample preparation and chromatographic conditions on background signal level in HPLC-UV analysis of blood plasma. //Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya = Тhе Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. – 2020, Vol. 10(2). – P. 121-128.
Kosman V.M., Faustova N.M., Pozharitskaya O.N., Shikov A.N., Makarov V.G.Development, validation and application of immunoenzyme assay for the standardization of biopreparation// Razrabotka i registratsiya lekarstvennykh sredstv = Drug development & registration. – 2015, №2 (11). – P 176-184.
Karlina M.V., Pozharitskaya O.N., Kosman V.M. HPLC-UV method for quantification of shisandrol A in rat plasma: validation and application to a pharmacokinetic study // Review on Clinical pharmacology and medicinal therapy, 2012, Vol. 10(2), Abstracts book of 16-th Int. Congress “Phytopharm 2012”, Saint-Petersburg, Russia, 9-11.07.2012, M. 63
Pozharitskaya O.N., Kosman V.M., Karlina M. V., Shikov A.N., Makarov V.G., Djachuk G. Method development and validation of an HPLC assay for the detection of hopantenic acid in human plasma and its application to a pharmacokinetic study on volunteers // Acta chromatographica. – 2011, Vol. 23. – P. 403-414.
Guseva S.I., Shikov A.N., Karlina M.V., Pozharitskaya O.N., Faustova N.M. Validation of a quantitative determination method of diclofenac for in vitro bioequivalence evaluation of transdermal gel preparations // Pharmaceutical Chemistry Journal. – 2010,Vol. 44(1). – Р. 43-46.
Karlina M.V., Pozharitskaya O.N., Shikov A.N., Kosman V. M., Makarova M.N., Makarov V.G. LC Method for Quantification of Lutein in Rat Plasma: Validation, and Application to a Pharmacokinetic Study // Chromatographia. – 2008, Vol. 68 (№11-12). – P. 949-954.
