phkineticaФармакокинетика и ФармакодинамикаPharmacokinetics and Pharmacodynamics2587-78362686-8830ООО «Издательство ОКИ»10.37489/2587-7836-2021-3-12-19phkinetica-289Research ArticleОБЗОРЫREVIEWSОрганизация фармакокинетических исследованийOrganizing of pharmacokinetic investigationshttps://orcid.org/0000-0003-4950-5336МирошниченкоИ. И.MiroshnichenkoI. I.

Мирошниченко Игорь Иванович - д. м. н., заведующий лабораторией фармакокинетикиSPIN-код: 4117-9703

Москва

Miroshnichenko Igor I. - Dr. Sci. (Med.), Head of pharmacokinetics laboratorySPIN code: 4117-9703

Moscow

igormir@psychiatry.ruhttps://orcid.org/0000-0002-0693-2007КравцоваО. Ю.KravtsovaO. Y.

Кравцова Оксана Юрьевна - к. б. н., н. с. лаборатории фармакокинетикиSPIN-код: 1733-2330

Москва

Kravtsova Oxana Yu. - PhD in Biology, Researcher scientist of pharmacokinetics laboratorySPIN code: 1733-2330

Moscow

oukravtsova@yahoo.comФГБНУ "Научный центр психического здоровья"РоссияResearch Center of NeurologyRussian FederationФГБНУ «НИИ фармакологии имени В.В. Закусова»РоссияFSBI “Zakusov Institute of Pharmacology”Russian Federation202114022022031219Copyright © Мирошниченко И.И., Кравцова О.Ю., 20222022Мирошниченко И.И., Кравцова О.Ю.Miroshnichenko I.I., Kravtsova O.Y.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmacokinetica.ru/jour/article/view/289

Статья посвящена различным аспектам организации исследований фармакокинетики лекарственных средств как на доклиническом, так и клиническом уровнях (изучение биоэквивалентности, терапевтический лекарственный мониторинг, оптимизация режимов дозирования), а также обустройству работы и оснащению (оборудование, химические реактивы, помещения, персонал) фармакокинетической лаборатории.

The paper is devoted to various aspects of the organization of drug pharmacokinetics research both at the preclinical and clinical levels (bioequivalence study, therapeutic drug monitoring, optimization of dosage regimens), as well as the arrangement of work and equipment (instrumentation, chemicals, premises, personnels) of the pharmacokinetic laboratory.

организация исследованийфармакокинетикабиоэквивалентностьтерапевтический лекарственный мониторингфармакокинетическая лабораторияметоды исследованияresearch organizationpharmacokineticsbioequivalencetherapeutic drug monitoringpharmacokinetic laboratoryresearch methodsReferencesGuan L, Yang H, Cai Y, et al. ADMET-score – a comprehensive scoring function for evaluation of chemical drug-likeness. Medchemcomm. 2018;10(1):148–157. DOI:10.1039/c8md00472b.Guan L, Yang H, Cai Y, et al. ADMET-score – a comprehensive scoring function for evaluation of chemical drug-likeness. Medchemcomm. 2018;10(1):148–157. DOI:10.1039/c8md00472b.Gabrielsson J, Weiner D. Non-compartmental Analysis. Methods Mol Biol. 2012; 929:377–389. DOI:10.1007/978-1-62703-050-2-16.Gabrielsson J, Weiner D. Non-compartmental Analysis. Methods Mol Biol. 2012; 929:377–389. DOI:10.1007/978-1-62703-050-2-16.Мирошниченко И.И. Рациональное дозирование и мониторинг лекарственных средств. – Москва: Медицинское информационное агентство; 2011. – 416 c.Miroshnichenko II. Rational dosing and monitoring of medicines. Moscow: Medical Information Agency 2011. (In Russ).Schneider F, Maurer C, Friedberg RC. International Organization for Standardization (ISO) 15189. Ann Lab Med. 2017;37(5):365–370. DOI:10.3343/alm.2017.37.5.365.Schneider F, Maurer C, Friedberg RC. International Organization for Standardization (ISO) 15189. Ann Lab Med. 2017;37(5):365–370. DOI:10.3343/alm.2017.37.5.365.Ezzelle J, Rodriguez-Chavez IR, Darden JM et al. Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories. Journal of Pharmaceutical and Biomedical Analysis. 2008;46(1):18–29. DOI:10.1016/j.jpba.2007.10.010.Ezzelle J, Rodriguez-Chavez IR, Darden JM et al. Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories. Journal of Pharmaceutical and Biomedical Analysis. 2008;46(1):18–29. DOI:10.1016/j.jpba.2007.10.010.Ito K, Someya H. Good Laboratory Practice: Initial Development, Necessity, and Issues of Data Reliability in Basic Research. Yakugaku Zasshi. 2019;139(6):875–879. DOI:10.1248/yakushi.18-00193-1.Ito K, Someya H. Good Laboratory Practice: Initial Development, Necessity, and Issues of Data Reliability in Basic Research. Yakugaku Zasshi. 2019;139(6):875–879. DOI:10.1248/yakushi.18-00193-1.Селезнева А.И., Смирнов В.А., Горячкин В.В., Чадова Н.Н., Поляков С.В., Шестаков В.Н., Абрамович Р.А. Интегрированная модель системы менеджмента качества лабораторных исследований лекарственных средств. Разработка и регистрация лекарственных средств. 2021;10(3):148–165. DOI:10.33380/2305-2066-2021-10-3-148-165.Selezneva A.I, Smirnov VA, Goryachkin VV, Chadova NN, Polyakov SV, Shestakov VN, Abramovich RA. The integrated model of quality management system of laboratory studies of medicines. Razrabotka i registratsiya lekarstvennykh sredstv = Drug development & registration. 2021;10(3):148–165. (In Russ). DOI:10.33380/2305-2066-2021-10-3-148-165.Buonarati MH, Schoener D. Investigations beyond standard operating procedure on internal standard response. Bioanalysis. 2019;11(18):1669–1678. DOI:10.4155/bio-2019-0187.Buonarati MH, Schoener D. Investigations beyond standard operating procedure on internal standard response. Bioanalysis. 2019;11(18):1669–1678. DOI:10.4155/bio-2019-0187.Summerfield S, Hayes R, Liang M et al. The business of bioanalysis: new technology integration into bioanalytical workflows. Bioanalysis. 2018;10(22):1775–1779. DOI:10.4155/bio-2018-0269.Summerfield S, Hayes R, Liang M et al. The business of bioanalysis: new technology integration into bioanalytical workflows. Bioanalysis. 2018;10(22):1775–1779. DOI:10.4155/bio-2018-0269.van Andel L, Rosing H, Schellens JH, Beijnen JH. Review of Chromatographic Bioanalytical Assays for the Quantitative Determination of Marine-Derived Drugs for Cancer Treatment. Mar Drugs. 2018;6(7):246. DOI:10.3390/md16070246.van Andel L, Rosing H, Schellens JH, Beijnen JH. Review of Chromatographic Bioanalytical Assays for the Quantitative Determination of Marine-Derived Drugs for Cancer Treatment. Mar Drugs. 2018;6(7):246. DOI:10.3390/md16070246.Glahn-Martínez B, Benito-Peña E, Salis F et al. Sensitive rapid fluorescence polarization immunoassay for free mycophenolic acid determination in human serum and plasma. Anal. Chem. 2018;90(8):5459–5465. DOI:10.1021/acs.analchem.8b00780.Glahn-Martínez B, Benito-Peña E, Salis F et al. Sensitive rapid fluorescence polarization immunoassay for free mycophenolic acid determination in human serum and plasma. Anal. Chem. 2018;90(8):5459–5465. DOI:10.1021/acs.analchem.8b00780.Weinstein EA, Liu L, Ordonez AA et al. Noninvasive Determination of 2-[18F]-Fluoroisonicotinic Acid Hydrazide Pharmacokinetics by Positron Emission Tomography in Mycobacterium tuberculosis-Infected Mice. Antimicrob Agents Chemother. 2012;56(12):6284–6290. DOI:10.1128/AAC.01644-12.Weinstein EA, Liu L, Ordonez AA et al. Noninvasive Determination of 2-[18F]-Fluoroisonicotinic Acid Hydrazide Pharmacokinetics by Positron Emission Tomography in Mycobacterium tuberculosis-Infected Mice. Antimicrob Agents Chemother. 2012;56(12):6284–6290. DOI:10.1128/AAC.01644-12.Kerns EH and Di L. Drug-like properties: concepts, structure design, and methods: from ADME to toxicity optimization. – Academic Press (is an imprint of Elsevir); 2008.Kerns EH and Di L. Drug-like properties: concepts, structure design, and methods: from ADME to toxicity optimization. – Academic Press (is an imprint of Elsevir); 2008.Руководство по проведению доклинических исследований лекарственных средств. Часть первая./ Миронов А.Н. (гл. ред.) – М.: Гриф и К; 2013. – 944 с.Rukovodstvo po provedeniu doclinicheskih issledovanii lekarstvennykh sredstv. First part. Ed by Mironov AN. Moscow: Grif i K; 2013. (In Russ).Rosenthal WM. Establishing a pharmacy-based laboratory service. J Am Pharm Assoc (Wash). Mar-Apr 2000;40(2):146–152, 154–156; quiz 321-323.Rosenthal WM. Establishing a pharmacy-based laboratory service. J Am Pharm Assoc (Wash). Mar-Apr 2000;40(2):146–152, 154–156; quiz 321-323.Konstantinou GN. Enzyme-Linked Immunosorbent Assay (ELISA). Methods Mol Biol. 2017;1592:79–94. DOI:10.1007/978-1-4939-6925-8-7.Konstantinou GN. Enzyme-Linked Immunosorbent Assay (ELISA). Methods Mol Biol. 2017;1592:79–94. DOI:10.1007/978-1-4939-6925-8-7.Brandhorst G, Oellerich M, Maine G et al. Liquid chromatography–tandem mass spectrometry or automated immunoassays: what are the future trends in therapeutic drug monitoring? Clin. Chem. 2012;58(5):821–825. DOI:10.1373/clinchem.2011.167189.Brandhorst G, Oellerich M, Maine G et al. Liquid chromatography–tandem mass spectrometry or automated immunoassays: what are the future trends in therapeutic drug monitoring? Clin. Chem. 2012;58(5):821–825. DOI:10.1373/clinchem.2011.167189.Мирошниченко И.И., Шилов Ю.Е. Анализ биологических образцов в современной лабораторной практике (обзор). Разработка и регистрация лекарственных средств. 2019;8(2):115-120. DOI:10.33380/23052066-2019-8-2-115-120.Miroshnichenko II, Shilov YE. Analysis of Biological Samples in a Contemporary Laboratory Practice (Review). Drug development & registration. 2019;8(2):115–120. (In Russ). DOI:10.33380/23052066-2019-8-2-115-120.Хохлов А.Л., Рыска М., Кукес В.Г. и др. Теоретические и практические основы проведения исследований воспроизведенных лекарственных препаратов. – Москва-Ярославль-Прага: ООО Фотолайф; 2017. – 227 с.Hohlov AL, Ryska M, Kukes VG et al. Theoretical and practical bases of research of reproduced drugs. Мoscow-Praga-Yaroslavl: Photolife LLC; 2017. (In Russ).Макаров А. Масс-спектрометры Thermo Fisher Scientific. ORBITRAP – 10 лет прогресса. Аналитика. 2016;5(30):22-37. URL: https://www.janalytics.ru/journal/article/5675. Ссылка активна на: 04.11.2021Makarov A. Mass spectrometers Thermo Fisher Scientific. ORBITRAP — 10 years of progress. Analytics. 2016;5(30):22–37. (In Russ) URL: https://www.janalytics.ru/journal/article/5675.Tan A, Fanaras JC. Use of high-pH (basic/alkaline) mobile phases for LC-MS or LC-MS/MS bioanalysis. Biomed Chromatogr. 2019;33(1):e4409. DOI:10.1002/bmc.4409.Tan A, Fanaras JC. Use of high-pH (basic/alkaline) mobile phases for LC-MS or LC-MS/MS bioanalysis. Biomed Chromatogr. 2019;33(1):e4409. DOI:10.1002/bmc.4409.Armstrong M, Jonscher K, Reisdorph NA. Analysis of 25 underivatized amino acids in human plasma using ion-pairing reversed-phase liquid chromatography/time-of-flight mass spectrometry. Rapid Commun. Mass Spectrom. 2007;21(16):2717–2726. DOI:10.1002/rcm.3124.Armstrong M, Jonscher K, Reisdorph NA. Analysis of 25 underivatized amino acids in human plasma using ion-pairing reversed-phase liquid chromatography/time-of-flight mass spectrometry. Rapid Commun. Mass Spectrom. 2007;21(16):2717–2726. DOI:10.1002/rcm.3124.Жердев В.П., Литвин А.А. Роль и организация фармакокинетических исследований. Клиническая фармакокинетика. 2005;2(3):1–3.Zherdev VP, Litvin AA. The role and organization of pharmacokinetic research. Clinical pharmacokinetics. 2005;2(3):1–3. (In Russ).Кукес В.Г. Клиническая фармакокинетика: теоретические, прикладные и политические аспекты. – М.: ГЭОТАР-Медиа; 2009. – 432 c.Kukes VG. Clinical pharmacokinetics: theoretical, applied and political aspects. Мoscow: GEOTAR-Media; 2009. (In Russ).Sturkenboom MGG, Märtson A-G, Svensson EM et al. Population Pharmacokinetics and Bayesian Dose Adjustment to Advance TDM of AntiTB Drugs. Clin Pharmacokinet. 2021; 60(6):685–710. DOI:10.1007/s40262-021-00997-0.Sturkenboom MGG, Märtson A-G, Svensson EM et al. Population Pharmacokinetics and Bayesian Dose Adjustment to Advance TDM of AntiTB Drugs. Clin Pharmacokinet. 2021; 60(6):685–710. DOI:10.1007/s40262-021-00997-0.Capecchi R, Puxeddu I, Prates F, Migliorini P. New biomarkers in SLE: from bench to bedside. Rheumatology (Oxford). 2020;59(Suppl.5):v12–v18. DOI:10.1093/rheumatology/keaa484.Capecchi R, Puxeddu I, Prates F, Migliorini P. New biomarkers in SLE: from bench to bedside. Rheumatology (Oxford). 2020;59(Suppl.5):v12–v18. DOI:10.1093/rheumatology/keaa484.

The authors declare that there are no conflicts of interest present.