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.
Publications on topic:
Ivanova S. A., Pozharitskaya O. N. Study of botulin bioavailability from lipid systems with dry extract of birch bark at topical application in vitro and in vivo // the IX International Congress “Actual problems of creation of new medicinal preparation of natural origin” Phytopharm, 2005. P. 497-501.
Karlina M.V., Eshchenko A.Yu., Pozharitskaya O.N., Dyachuk G.I. Studying of biological availability of the betulin from the oil suspension in experiences in vitro and in vivo // the VIII International Congress “Actual problems of creation new medicinal preparations of natural origin” Phytopharm, 2004. – Р. 665-669.
Karlina M.V., Pozharitskaya O.N., Kosman V.M., Ivanova S.A. Bioavailability of boswellic acids: In vitro / in vivo correlation // Pharmaceutical Chemistry Journal. – 2007, Vol. 41 (11). – Р. 38-41.
Karlina M.V, Pozharitskaya O.N., Ivanova S. A. Pharmacokinetics of curcuminoids contained in «Arthroflex» preparation// Pharmaceutical Chemistry Journal. – 2007, Vol. 41(10). – Р. 3-5.
Ivanova S.A., Pozharitskaya O.N., Karlina M.V.,Makarov V.G. Application of HPTLC in pharmaceutical studies of triterpenoides of Boswellia serrata Roxb. Extract// Problems of biological, medical and pharmaceutical chemistry. – 2008, №6. – P. 59-63.
Pozharitskaya O.N., Karlina M.V., Shikov A N., Kosman V.M., Makarova M.N., Makarov V.G. Determination of icariin in rat plasma by reverse-phase high-performance liquid chromatography after oral administration of lipid-based suspension of Epimedium koreanum extract // Biomed. Chromatogr. – 2008, 22. – P. 625-629.
Karlina M.V.,Pozharitskaya O.N., Dadalilu.V., Kosman V.M., Shikov A.N., Makarov V.G. Light-Absorbing and antiradical properties of a product with lutein and zeaxanthin in vitro and kinetics of carotinoids at single oral administration on rats // Problems of Nutrition. – 2008, Vol.77 (№3). – P 34-38.
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). – 949-954.
Pozharitskaya О.N., Karlina M.V., Shikov A.N., Kosman V.M., Makarova M.N., Makarov V.G. Determination and pharmacokinetic study of taxifolin in rabbit plasma by high-performance liquid chromatography // Phytomedicine. – 2009, Vol. 16. – 244-251.
Karlina M.V., Pozharitskaya O.N., Kosman V.M., Shikov A.N., Lazukina M.A., D’yachuk G. I. Pharmacokinetics of hopantenic acid upon peroral administration// Éksperimentalnaya i Klinicheskaya Farmakologiya=Experimental and Clinical Pharmacology. – 2010, Vol.73(8). – P46-48.
Pozharitskaya O.N., Kosman V.M., Karlina 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.
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, Т. 10, Вып. 2, Abstracts book of 16-th Int. Congress “Phytopharm 2012”, Saint-Petersburg, Russia, 9-11.07.2012, M. 63.
Karlina M.V., Pozharitskaya O.N., Kosman V.M, Shikov A.N., Zabozlaev A.A., Makarova M.N, Makarov V.G. A model for in vitro evaluation of the release of hydrophobic compounds from lozenges tablets with coenzyme Q10 and in vivo/in vitro correlation// Pharmaceutical Chemistry Journal. – 2012, Vol. 46 (7). – 52-55.
Karlina M.V., Pozharitskaya O.N., Kosman V.M., Shikov A.N., Zabozlaev A.A., Makarova M.N., Makarov V.G., An in vitro model for evaluation of the release of hydrophibic compounds from coenzyme Q10 lozenges and in vivo/in vitro correlation// Pharmaceutical Chemistry Journal. – 2012, Vol. 46(7). – 456-459.
Karlina M.V., Pozharitskaya O.N., Kosman V.M., Shikov A.N., Balabanyan V.U. Comparative pharmacokinetics of free and liposome-encapsulated quercetin after intravenous administration in rats // Review on Clinical pharmacology and medicinal therapy, 2013, Т. 11, Abstracts book of 17-th Int. Congress “Phytopharm 2013”, Vienna, Austria, 8-10.07.2013. – P. 45.
Kosman V.M., Pozharitskaya O.N., Karlina M.V., Shikov A.N., Makarov V.G, Pharmacokinetics of lignans from SHISANDRA CHINENSIS // Review on Clinical pharmacology and medicinal therapy, 2013, Т. 11, Abstracts book of 17-th Int. Congress “Phytopharm 2013”, Vienna, Austria, 8-10.07.2013. – 55.
Carlina M.V., Cosman V.M., Pozharitskaya O.N., Shikov A.N., Makarova M.N., Makarov V.G., Balabanyan V.Y. Experimental study of the pharmacokinetics of rifabutin in liposomal form // Pharmacokinetics and Pharmacodynamics. – 2013, Vol. 1 (6). – 37-41.
Karlina M.V., Kosman V.M., Pozharitskaya O.N., Shikov A.N., Makarov V.G., Fharmacokinetic of schizandrol a on rats after application of schizandra chinensis oil extract // Razrabotka i registraciâ lekarstvennyh sredstv=Drug development & registration. – 2014, №1(6). – P 126-131.
Karlina M.V., Pozharitskaya O.N., Kosman V.M., Shikov A.N., Balabanyan V.U. Study of distribution of liposome-encapsulated cytochrome C in ocular tissue of rabbit after single topical application // Review on Clinical pharmacology and medicinal therapy, 2014, Vol. 12, Abstracts book of 18-th Int. Congress “Phytopharm 2014”, St-Petersburg, Russia, 3-5.07.2014, P. 31.
Kosman V.M., Karlina M.V., Pozharitskaya O.N., Shikov A.N., Makarov V.G., Vorobieva V.V., Lapkina G.Ya. Pharmacokinetics of lignans from Schisandra chinenis // Review on Clinical pharmacology and medicinal therapy. – 2015, Vol. 13 (4). – P 3-21.
Karlina M.V., Kosman V.M., Pozharitskaya O.N., Shikov A.N., Makarov V.G. Experimental Study of Pharmacokinetics of Ketoprofen Nanosystem for Inhalation Administration // Éksperimentalnaya i Klinicheskaya Farmakologiya=Experimental and Clinical Pharmacology. – 2016, Vol. 79 (7). – 21-24.
Kosman V.M., Faustova N.M., Karlina M.V., PozharitskayaN. Immunoassay as analytical method in pharmacokinetic and toxicokinetic investigations// Review on Clinical pharmacology and medicinal therapy, 2016, Т. 14, Abstracts book of 20-th Int. Congress “Phytopharm 2016”, Saint-Petersburg, Russia, 11-14.07.2016. – P. 28.
Karlina M.V., Faustova N.M., Pozharitskaya O.N., Kosman V.M., Makarov V.G., Shikov A.N. Determination of darbepoetin alfa in rabbit plasma by elisa // Razrabotka i registratsiya lekarstvennykh sredstv = Drug development & registration. – 2016, № 4(17). – 204-209.
Pozharitskaya O.N., Karlina M.V., Shikov A.N., Kosman V.M., Makarov V.G., Rosenholm J. Pharmacokinetics and Tissue Disposition of Betulin after Endotracheal Administration to Rats // Eur J Drug Metab Pharmacokinet. – 2017, Vol. 42. – 327-332.
Kosman V.M., Faustova N.M., Pozharitskaya O.N., Shikov A.N. Pharmacokinetics of new bioactive peptide from Strongylocentrotus droebachiensis // Review on Clinical pharmacology and medicinal therapy, 2017, Т. 15, Abstracts book of 21-th Int. Congress “Phytopharm 2017”, Graz, Austria, 2-5.07.2017, P. 35.
Pozharitskaya O.N., Kosman V.M., Faustova N.M., Obluchinskaya E.D., Shikov A.N. Investigation of anti-activated factor X (anti-Xa) assay for the quantification of fucoidan in rodents // Review on Clinical pharmacology and medicinal therapy, 2017, Т. 15, Abstracts book of 21-th Int. Congress “Phytopharm 2017”, Graz, Austria, 2-5.07.2017, P. 55.
N. Pozharitskaya, A.N. Shikov, N.M. Faustova, E.D. Obluchinskaya, V.М. Kosman, H. Vuorela, V.G. Makarov Pharmacokinetic and Tissue Distribution of Fucoidan from Fucus vesiculosus after Oral Administration to Rats // Marine Drugs. – 2018, Vol. 16. – P. 132-142.
Kosman V.M., Faustova N.M., Pozharitskaya O.N., Shikov A.N. Various approaches to pharmacokinetic study of Adelandak – Strongylocentrotus droebachiensis gonads extract Review on Clinical pharmacology and medicinal therapy, 2018, Т. 16, Abstracts book of 22-d Int. Congress “Phytopharm 2018”, Horgen, Switzerland, 25-27.06.2018. – 59-60.
Kosman V.M., Faustova N.M., PozharitskayaN., Shikov A.N. // Approaches to pharmacokinetics study of natural origin drugs based on biological activity // Review on Clinical pharmacology and medicinal therapy, 2019, Т. 17, Abstracts book of 23-d Int. Congress “Phytopharm 2019”, Санкт-Петербург, Россия, 01-03.07.2013, P. 32.
Shikov A.N., PozharitskayaN., Faustova N.M., Kosman V.M., Razzazi-Fazeli E., Novak J. Pharmacokinetic Study of Bioactive Glycopeptide from Strongylocentrotus droebachiensis after Intranasal Administration to Rats Using Biomarker Approach // Marine Drugs. – 2019, Vol. 17. – P. 577-590.
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, Vol. 9(3). – P. 158-165.
