Search Results - "ОБСЕРВАЦИОННЫЕ ИССЛЕДОВАНИЯ"

1

Academic Journal

A systematic review of real-world clinical practice data in COVID-19: non-interventional studies ; Систематический обзор данных реальной клинической практики при COVID-19: неинтервенционные исследования

Authors: S. A. Mishinova, Yu. M. Gomon, A. S. Kolbin, V. V. Strizheletsky, I. G. Ivanov, С. А. Мишинова, Ю. М. Гомон, А. С. Колбин, В. В. Стрижелецкий, И. Г. Иванов

Source: FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology; Vol 15, No 1 (2022); 145-161 ; ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология; Vol 15, No 1 (2022); 145-161 ; 2070-4933 ; 2070-4909

Subject Terms: китайская медицина, observational studies, evidence-based medicine, COVID-19, coronavirus disease 2019, azithromycin, hydroxychloroquine, severe acute respiratory syndrome, traditional Chinese medicine, обсервационные исследования, доказательная медицина, коронавирусная болезнь 2019, азитромицин, гидроксихлорохин, тяжелый острый респираторный синдром

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Relation: https://www.pharmacoeconomics.ru/jour/article/view/664/420; European Centre for Disease Prevention and Control. COVID-19. Situation updates. URL: https://www.ecdc.europa.eu/en/covid-19-pandemic (дата обращения 29.11.2021).; Coronavirus Vaccine Tracker. URL: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html (дата обращения 29.11.2021).; Колбин А.С. COVID-19 и клиническая фармакология. Клиническая фармакология и терапия. 2020; 29 (3): 1–11. https://doi.org/10.32756/0869-5490-2020-3-14-24.; Мишинова С.А., Журавков А.А., Журавко В.К. Назначение официально не разрешенных к применению лекарственных средств и использование лекарственных средств с нарушением инструкции по применению: фокус на COVID-19. Качественная клиническая практика. 2020; 4S: 120–9. https://doi.org/10.37489/2588-0519-2020-S4-120-129.; Global Coronavirus COVID-19 Clinical Trial Tracker. URL: https://www.covid-trials.org/ (дата обращения 29.11.2021).; Framework for FDA’S Real-World Evidence Program. URL: https://www.fda.gov/media/120060/download (дата обращения 29.11.2021).; Колбин А.С. (ред.) Исследования реальной клинической практики. М.: Издательство ОКИ; 2020: 208 с.; PRISMA transparent reporting of systematic reviews and metaanalyses. URL: http://www.prisma-statement.org/ (дата обращения 29.11.2021).; Ip A., Berry D.A., Hansen E., et al. Hydroxychloroquine and tocilizumab therapy in COVID-19 patients – an observational study. PloS One. 2020; 15 (8): e0237693. https://doi.org/10.1371/journal.pone.0237693.; Monreal Е., Sainz de la Maza S., Natera-Villalba E., et al. High versus standard doses of corticosteroids in severe COVID-19: a retrospective cohort study. Eur J Clin Microbiol Infect Dis. 2021; 40 (4): 761–9. https://doi.org/10.1007/s10096-020-04078-1.; Khunti K., Knighton P., Zaccardi F., et al. Prescription of glucoselowering therapies and risk of COVID-19 mortality in people with type 2 diabetes: a nationwide observational study in England. Lancet Diabetes Endocrinol. 2021; 9 (5): 293–303. https://doi.org/10.1016/S2213-8587(21)00050-4.; Francis N.А., Stuart B., Knight M., et al. Predictors of clinical deterioration in patients with suspected COVID-19 managed in a ‘virtual hospital’ setting: a cohort study. BMJ Open. 2021; 11 (3): e045356. https://doi.org/10.1136/bmjopen-2020-045356.; Shu Z., Chang K., Zhou Y., et al. Add-On Chinese Medicine for Coronavirus Disease 2019 (ACCORD): a retrospective cohort study of hospital registries. Am J Chin Med. 2021; 49 (3): 543–75. https://doi.org/10.1142/S0192415X21500257.; Sun J., Deng X., Chen X., et al. Incidence of adverse drug reactions in COVID-19 patients in China: an active monitoring study by Hospital Pharmacovigilance System. Clin Pharmacol Ther. 2020; 108 (4): 791– 7. https://doi.org/10.1002/cpt.1866.; Liu X., Liu Y., Wang L., et al. Analysis of the prophylactic effect of thymosin drugs on COVID-19 for 435 medical staff: a hospital-based retrospective study. J Med Virol. 2021; 93 (3): 1573–80. https://doi.org/10.1002/jmv.26492.; Annie F.H., Sirbu C., Frazier K.R., et al. Hydroxychloroquine in hospitalized patients with COVID-19: real-world experience assessing mortality. Pharmacotherapy. 2020; 40 (11): 1072–81. https://doi.org/10.1002/phar.2467.; Trifirò G., Massari M., Da Cas R., et al. Renin-angiotensinaldosterone system inhibitors and risk of death in patients hospitalised with COVID-19: a retrospective italian cohort study of 43,000 patients. Drug Saf. 2020; 43 (12): 1297–308. https://doi.org/10.1007/s40264-020-00994-5.; Garcia P., Revet A., Yrondi A., et al. Psychiatric disorders and hydroxychloroquine for coronavirus disease 2019 (COVID-19): a VigiBase study. Drug Saf. 2020; 43 (12): 1315–22. https://doi.org/10.1007/s40264-020-01013-3.; Rubio-Rivas M., Ronda M., Padulles A., et al. Beneficial effect of corticosteroids in preventing mortality in patients receiving tocilizumab to treat severe COVID-19 illness. Int J Infect Dis. 2020; 101: 290–7. https://doi.org/10.1016/j.ijid.2020.09.1486.; Zhou F., Yu T., Du R., et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020; 395 (10229): 1054–62. https://doi.org/10.1016/S0140-6736(20)30566-3.; Biran N., Ip A., Ahn J., et al. Tocilizumab among patients with COVID-19 in the intensive care unit: a multicentre observational study. Lancet Rheumatol. 2020; 2 (10): e603–12. https://doi.org/10.1016/S2665-9913(20)30277-0.; Gervasoni C., Meraviglia P., Riva A., et al. Clinical features and outcomes of patients with human immunodeficiency virus with COVID-19. Clin Infect Dis. 2020; 71 (16): 2276–8. https://doi.org/10.1093/cid/ciaa579.; Russo V., Cardillo G., Viggiano G.V., et al. Fondaparinux use in patients with COVID-19: a preliminary multicenter real-world experience. J Cardiovasc Pharmacol. 2020; 76 (4): 369–71. https://doi.org/10.1097/FJC.0000000000000893.; Chouchana L., Boujaafar S., Gana I., et al. plasma concentrations and safety of lopinavir/ritonavir in COVID-19 patients. Ther Drug Monit. 2021; 43 (1): 131–5. https://doi.org/10.1097/FTD.0000000000000838.; Tsukamoto M., Suzuki K., Tsunoda K., et al. Value of labial salivary gland histopathology for diagnosis of Sjögren's syndrome in patients with anti-centromere antibody positivity. Int J Rheum Dis. 2020; 23 (8): 1024–9. https://doi.org/10.1111/1756-185X.13895.; Cook G., Ashcroft A.J., Pratt G., et al. Real-world assessment of the clinical impact of symptomatic infection with severe acute respiratory syndrome coronavirus (COVID-19 disease) in patients with multiple myeloma receiving systemic anti-cancer therapy. Br J Haematol. 2020; 190 (2): e83–6. https://doi.org/10.1111/bjh.16874.; Gironi L.C., Damiani G., Zavattaro E., et al. Tetracyclines in COVID-19 patients quarantined at home: literature evidence supporting real-world data from a multicenter observational study targeting inflammatory and infectious dermatoses. Dermatol Ther. 2021: 34 (1): e14694. https://doi.org/10.1111/dth.14694.; Rivera-Caravaca J.M., Núñez-Gil I.J., Vivas D., et al. Clinical profile and prognosis in patients on oral anticoagulation before admission for COVID-19. Eur J Clin Invest. 2021; 51 (1): e13436. https://doi.org/10.1111/eci.13436.; Zeng Q.L., Li G.M., Ji F., et al. Clinical course and treatment efficacy of COVID-19 near Hubei Province, China: a multicentre, retrospective study. Transbound Emerg Dis. 2020; 67 (6): 2971–82. https://doi.org/10.1111/tbed.13674.; Rentsch C.T., Beckman J.A., Tomlinson L., et al. Early initiation of prophylactic anticoagulation for prevention of coronavirus disease 2019 mortality in patients admitted to hospital in the United States: cohort study. BMJ. 2021; 372: n311. https://doi.org/10.1136/bmj.n311.; Caraballo C., McCullough M., Fuery M.A., et al. COVID-19 infections and outcomes in a live registry of heart failure patients across an integrated health care system. PloS One. 2020; 15 (9): e0238829. https://doi.org/10.1371/journal.pone.0238829.; Flisiak R., Zarębska-Michaluk D., Berkan-Kawińska A., et al. Remdesivir-based therapy improved recovery of patients with COVID-19 in the SARSTer study. Pol Arch Intern Med. 2021; 131 (1): 103–10. https://doi.org/10.20452/pamw.15735.; De Vito A., Geremia N., Princic E., et al. Does angiotensin II receptor blockers increase the risk of SARS-CoV-2 infection? A real-life experience. Eur Rev Med Pharmacol Sci. 2021; 25 (1): 523–6. https://doi.org/10.26355/eurrev_202101_24424.; Антонов В.Н., Игнатова Г.Л., Прибыткова О.В. и др. Опыт применения олокизумаба у больных COVID-19. Терапевтический архив. 2020; 92 (12): 148–54. https://doi.org/10.26442/00403660.2020.12.200522.; Tanriverdi E., Çörtük M., Yildirim B.Z., et al. Hydroxychloroquine plus azithromycin and early hospital admission are beneficial in COVID-19 patients: Turkish experience with real-life data. Turk J Med Sci. 2021; 51 (1): 10–5. https://doi.org/10.3906/sag-2005-82.; Nachega J.B., Ishoso D.K., Otokoye J.O., et al. Clinical characteristics and outcomes of patients hospitalized for COVID-19 in Africa: early insights from the Democratic Republic of the Congo. Am J Trop Med Hyg. 2020; 103 (6): 2419–28. https://doi.org/10.4269/ajtmh.20-1240.; Gore V., Kshirsagar D.P., Bhat S.M., et al. Itolizumab treatment for cytokine release syndrome in moderate to severe acute respiratory distress syndrome due to COVID-19: clinical outcomes, a retrospective study. J Assoc Physicians India. 2021; 69 (2): 13–8.; Karolyi M., Pawelka E., Mader T., et al. Hydroxychloroquine versus lopinavir/ritonavir in severe COVID-19 patients. Wien Klin Wochenschr. 2021; 133 (7): 284–91. https://doi.org/10.1007/s00508-020-01720-y.; Garcia-Vidal C., Meira F., Cózar-Llistó A., et al. Real-life use of remdesivir in hospitalized patients with COVID-19. Rev Esp Quimioter. 2021; 34 (2): 136–40. https://doi.org/10.37201/req/018.2021.; Hughes R., Whitley L., Fitovski K., et al. COVID-19 in ocrelizumabtreated people with multiple sclerosis. Mult Scler Relat Disord. 2021; 49: 102725. https://doi.org/10.1016/j.msard.2020.102725.; WHO R&D Blueprint. Novel coronavirus. COVID-19 therapeutic trial synopsis. URL: https://www.who.int/blueprint/priority-diseases/keyaction/COVID-19_Treatment_Trial_Design_Master_Protocol_ synopsis_Final_18022020.pdf (дата обращения 29.11.2021).; Марцевич С.Ю., Лукина Ю.В., Кутишенко Н.П. Еще раз об иерархии доказательств в медицине, или можно ли с помощью наблюдательных исследований решить вопрос о выборе наиболее эффективного и безопасного препарата. Рациональная фармакотерапия в кардиологии. 2017; 13 (2): 270–4. https://doi.org/10.20996/1819-6446-2017-13-2-270-274.; Franklin J.M., Lin K.J., Gatto N.M., et al. Real-world evidence for assessing pharmaceutical treatments in the context of COVID-19. Clin Pharmacol Ther. 2021; 109 (4): 816–28. https://doi.org/10.1002/cpt.2185.; “Guiding principles of real-word evidence supporting drug development and review (trial)” is formally promulgated by NMPA. URL: https://www.accestra.com/guiding-principles-of-real-worldevidence-supporting-drug-development-and-review-trial-is-formallypromulgated-by-nmpa/ (дата обращения 29.11.2021).; https://www.pharmacoeconomics.ru/jour/article/view/664

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https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.099

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2

Academic Journal

Pharmacoepidemiological studies: methodology and regulation

Authors: D. Yu. Belousov, A. E. Cheberda

Source: Качественная клиническая практика, Vol 0, Iss 1, Pp 34-41 (2018)

Subject Terms: фармакоэпидемиология, фармакоэпидемиологические исследования, надлежащая практика фармакоэпидемиологических исследований, пострегистрационные исследования, неинтервенционные исследования, неинвазивные исследования, обсервационные исследования, постмаркетинговые наблюдательные исследования, по-стрегистрационные исследования безопасности, когортные исследования, исследования случай-контроль, нежелательные лекарственные реакции, нежелательные лекарственные явления, pharmacoepidemiology, pharmacoepidemiology studies, good pharmacoepidemiology practice, post-marketing studies, non-interventional studies, non-invasive studies, observational studies, post-marketing surveillance studies, postauthorization safety studies, cohort study, adverse drugs reactions, adverse drugs events, Medical technology, R855-855.5, Pharmacy and materia medica, RS1-441

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Relation: https://www.clinvest.ru/jour/article/view/76; https://doaj.org/toc/2588-0519; https://doaj.org/toc/2618-8473

Access URL: https://doaj.org/article/5bccbea254b64cf6be23329eee258541

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3

Academic Journal

Non-interventional studies

Authors: D. Yu. Belousov

Source: Качественная клиническая практика, Vol 0, Iss 1, Pp 24-33 (2018)

File Description: electronic resource

Relation: https://www.clinvest.ru/jour/article/view/75; https://doaj.org/toc/2588-0519; https://doaj.org/toc/2618-8473

Access URL: https://doaj.org/article/85dae0168b5a46e5b57777521d0c17c9

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4

Academic Journal

Obesity as an oncological risk factor. Literature review ; Ожирение как фактор онкологического риска. Обзор литературы

Authors: V. V. Salukhov, D. V. Kadin, В. В. Салухов, Д. В. Кадин

Source: Meditsinskiy sovet = Medical Council; № 4 (2019); 94-102 ; Медицинский Совет; № 4 (2019); 94-102 ; 2658-5790 ; 2079-701X ; 10.21518/2079-701X-2019-4

Subject Terms: адипоцитокины, cancer, oncological risk, observational studies, Mendelian analysis, pathogenesis, adipocytokines, рак, онкологический риск, обсервационные исследования, Менделевский анализ, патогенез

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Genetic studies of body mass index yield new insights for obesity biology. Nature. 2015 Feb 12;518(7538):197-206.; Dixon S.C., Nagle C.M., Thrift A.P., Pharoah P.D., Pearce C.L., Zheng W., et al. Adult body mass index and risk of ovarian cancer by subtype: a Mendelian randomization study. Int J Epidemiol. 2016;45(3):884-95.; Carreras-Torres R., Johansson M., Haycock PC., Wade K.H., Relton C.L., Martin R.M., et al. Obesity, metabolic factors and risk of different histological types of lung cancer: A Mendelian randomization study. PloS One. 2017;12(6):e0177875.; Берштейн Л.М. Внегонадная продукция эстрогенов (роль в физиологии и патологии). СПб.: Наука, 1998. 172 p. [Berstein L.M. Extragonadal estrogen production (role in physiology and pathology). St. Petersburg: Science, 1998. 172 p.] (In Russ.); Key TJ., Appleby P.N., Reeves G.K., Roddam A., Dorgan J.F., Longcope C., et al. Body mass index, serum sex hormones, and breast cancer risk in postmenopausal women. 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Body mass index, weight change, and risk of prostate cancer in the Cancer Prevention Study II Nutrition Cohort. Cancer Epidemiol Biomark Prev Publ Am Assoc Cancer Res Cosponsored Am Soc Prev Oncol. 2007 Jan;16(1):63-9.; Fabian CJ., Kimler B.F., Donnelly J.E., Sullivan D.K., Klemp J.R., Petroff B.K., et al. Favorable modulation of benign breast tissue and serum risk biomarkers is associated with > 10% weight loss in postmenopausal women. Breast Cancer Res Treat. 2013 Nov;142(1):119-32.; Hursting S.D., Dunlap S.M., Ford N.A., Hursting MJ., Lashinger L.M. Calorie restriction and cancer prevention: a mechanistic perspective. Cancer Metab. 2013 Mar 7;1(1):10.; Thomson C.A., Horn L.V., Caan BJ., Aragaki A.K., Chlebowski R.T., Manson J.E., et al. Cancer Incidence and Mortality during the Intervention and Postintervention Periods of the Women's Health Initiative Dietary Modification Trial. Cancer Epidemiol Prev Biomark. 2014 Dec 1;23(12):2924-35.; Lv M., Zhu X., Wang H., Wang F., Guan W. Roles of Caloric Restriction, Ketogenic Diet and Intermittent Fasting during Initiation, Progression and Metastasis of Cancer in Animal Models: A Systematic Review and MetaAnalysis. PLOS ONE. 2014 Dec 11;9(12):e115147.; Kang H.C., Chung D.E., Kim D.W., Kim H.D. Early-and late-onset complications of the ketogenic diet for intractable epilepsy. Epilepsia. 2004 Sep;45(9):1116-23.; Scafoglio C.R., Villegas B., Abdelhady G., Bailey S. T., Liu J., Shirali A.S., et al. Sodium-glucose transporter 2 is a diagnostic and therapeutic target for early-stage lung adenocarcinoma. Sci Transl Med. 2018 Nov 14;10(467).; Pischon T., Nimptsch K. Obesity and Cancer. Springer; 2016. 258 p.

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https://doi.org/10.21518/2079-701X-2019-4-94-102

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5

Academic Journal

Non-interventional studies ; Неинтервенционные клинические исследования

Authors: D. Yu. Belousov, Д. Ю. Белоусов

Source: Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; № 1 (2017); 24-33 ; Качественная клиническая практика; № 1 (2017); 24-33 ; 2618-8473 ; 2588-0519

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Relation: https://www.clinvest.ru/jour/article/view/75/75; Федеральный закон № 61-ФЗ от 12.04.2010 «Об обращении лекарственных средств».; Национальный стандарт РФ ГОСТ-Р 52379-2005 «Надлежащая клиническая практика» (ICH E6 GCP), утвержденным приказом Федерального агентства по техническому регулированию и метрологии от 27.09.2005 № 232-ст.; Федеральный закон от 27.07.2006 г. № 12-ФЗ «О персональных данных».; Приказ Минздрава РФ № 200н от 01.04.2016 «Об утверждении правил надлежащей клинической практики».; Решение № 79 Об утверждении Правил надлежащей клинической практики Евразийского экономического союза от 03.11.2016.; Решение № 87 Об утверждении Правил надлежащей практики фармаконадзора Евразийского экономического союза от 03 ноября 2016 г.; Кодекс надлежащей практики Ассоциации международных фармацевтических производителей (AIPM) от 30.11.2015 г. http://www.aipm.org/etics/.; ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice (E6R2). November 2016.; Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.; EFPIA Code on the Promotion of prescription-only Medicines to, and Interactions with healthcare Professionals. // http://www.efpia.org/Content/Default.asp?PageID=366.; Good epidemiological Practice: IEA Guidelines for Proper Conduct of Epidemiological Research. Nov. 2007. // http://www.ieaweb.org/.; Флетчер Р., Флетчер С., Вагнер Э. Клиническая эпидемиология. Основы доказательной медицины. М.: Медиа Сфера, 1998; 352.; Вольская Е.А. Основы надлежащей практики неинтервенционных исследований лекарственных препаратов. Качественная клиническая практика, 2011; 1: 19-24. http://m.clinvest.ru/articles/item/osnovy-nadlezhashej-praktiki-neintervencionnyh-issledovanij-lekarstvennyh-preparatov.; Ягудина Р.И., Литвиненко М.М., Сороковиков И.В. Регистры пациентов: структура, функции, возможности использования. Фармакоэкономика. 2011; 4: 4: 3-7.; Основные понятия в оценке медицинских технологий. / Под общей ред. Колбина А.С., Зырянова С.К., Белоусова Д.Ю. М.: Издательство ОКИ, 2013.; https://www.clinvest.ru/jour/article/view/75

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6

Academic Journal

Pharmacoepidemiological studies: methodology and regulation ; Фармакоэпидемиологические исследования: методология и регулирование

Authors: D. Yu. Belousov, A. E. Cheberda, Д. Ю. Белоусов, А. Е. Чеберда

Source: Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; № 1 (2017); 34-41 ; Качественная клиническая практика; № 1 (2017); 34-41 ; 2618-8473 ; 2588-0519

Subject Terms: adverse drugs events, фармакоэпидемиологические исследования, надлежащая практика фармакоэпидемиологических исследований, пострегистрационные исследования, неинтервенционные исследования, неинвазивные исследования, обсервационные исследования, постмаркетинговые наблюдательные исследования, по-стрегистрационные исследования безопасности, когортные исследования, исследования случай-контроль, нежелательные лекарственные реакции, нежелательные лекарственные явления, pharmacoepidemiology, pharmacoepidemiology studies, good pharmacoepidemiology practice, post-marketing studies, non-interventional studies, non-invasive studies, observational studies, post-marketing surveillance studies, postauthorization safety studies, cohort study, adverse drugs reactions

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Relation: https://www.clinvest.ru/jour/article/view/76/76; Guidance for Industry and FDA Staff: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM243537.pdf.; Guideline on good Pharmacovigilance practices (GVP), Module VIII -Post-authorization safety studies (PASS). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf.; Guidance for the format and content of the protocol of non-interventional post-authorization safety studies. http://www.ema.europa.eu/docs/en_GB/document_library/0ther/2012/10/WC500133174.pdf.; AHRQ 2012. Methods guide for effectiveness and comparative effectiveness reviews. http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-andreports/?pageaction=displayproduct&productid=31.; Guidelines for good pharmacoepidemiology practice (GPP). pharmacoepidemiology and drug safety. 2016; 25: 2-10.; Флетчер Р., Флетчер С., Вагнер Э. Клиническая эпидемиология. Основы доказательной медицины. М.: Медиа Сфера, 1998; 352.; Зырянов С.К. Фармакоэпидемиология вчера, сегодня и завтра. Фарматека. 2003; 3: 13-17.; Прикладная фармакоэпидемиология. Учебник под редакцией академика РАМН В.И. Петрова. М.: 2008; 384.; Галанкин Т.Л., Колбин А.С. Роль рандомизированных исследований в фармакоэпидемиологии. Фармакоэкономика. 2014; 7 (1): 5-9.; Галанкин Т.Л., Вербицкая Е.В. Фармакоэпидемиология. Методическое пособие. / Под общей редакцией Колбина А.С. Первый Санкт-Петербургский Государственный Медицинский Университет им. акад. И.П. Павлова, 2015 г.; Рачина С.А., Козлов Р.С., Белькова Ю.А. Фармакоэпидемиология: от теоретических основ к практическому применению. Фармакоэкономика, 2015; 7: 1: 33-38.; Strom B.L. Study Designs Available for Pharmacoepidemiology Studies. In: Strom B.L., editor. Pharmacoepidemiology. 3d ed. New York: John Wiley & Sons, Inc. - 2000; 17-30.; Strom B.L. (ed). Pharmacoepidemiology (Fourth Edition). Sussex: John Wiley, 2005.; Strom B.L., Kimmel S.E. (eds). Textbook of Pharmacoepidemiology. Sussex: John Wiley, 2006.; Suruki R.Y., Chan K.A. Basic Pharmacoepidemiology Methods. In: Hartzema A.G., Tilson H.H, Chan K.A, editors. Pharmacoepidemiology and therapeutic risk assessment. Harwey Whitney Books, Cincinatti. 2008; P. 219-38.; Pharmacoepidemiology and drug safety http://www3.interscience.wiley.com/journal/5669/home; International Society for Pharmacoepidemiology http://www.pharmacoepi.org/index.cfm; International Society of Pharmacovigilance http://www.isoponline.org/.; European Network of Centres for Pharmacoepidemiology and Pharmacovigilance http://www.encepp.eu; ICH http://www.ich.org/products/guidelines.html; STROBE statement http://www.strobe-statement.org/; CONSORT statement including variants http://www.consort-statement.org/; MOOSE statement http://jama.jamanetwork.com/article.aspx?articleid=192614; GRACE principles http://www.graceprinciples.org/grace-p.html; The PCORI Methodology Report http://www.pcori.org/assets/2013/11/PC0RI-Methodology-Report.pdf; https://www.clinvest.ru/jour/article/view/76