The 21 references in paper V. Adonin K., D. Romodanovskiy P., R. Niyazov R., Владимир Адонин Константинович, Дмитрий Ромодановский Павлович, Равиль Ниязов Рашидович (2018) “Особенности проведения исследования биоэквивалентности лекарственных препаратов -аналогов эндогенных соединений // Specific features of the bioequivalence study of drugs - analogs of endogenous compounds” / spz:neicon:vedomostincesmp:y:2015:i:3:p:3-7

1
Mironov AN, ed. Manual on expertise of medicines. V. I. Moscow: Grif i K; 2013 (in Russian).
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2
Regulations of bioequivalence study of drugs of the Eurasian Economic Union (version 2, 20.02.2015). Available from: http://www.eurasiancommission.org/ru/ac t/texnreg/deptexreg/konsultComitet/Documents/ Правила%20БЭИ%20итог%2020.02.2015%20на%20сайт.pdf (in Russian).
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3
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. United States Food and Drug Administration. Available from: http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377465.pdf.
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4
Draft Guidance on Progesterone. United States Food and Drug Administration. Available from: http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM209294.pdf.
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5
Draft Guidance on Ethinyl Estradiol; Norethindrone. United States Food and Drug Administration. Available from: http://www.fda.gov/ucm/groups/ fdagov-public/@fdagov-drugs-gen/documents/document/ucm296893.pdf.
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6
Draft Guidance on Prednisolone Sodium Phosphate. United States Food and Drug Administration. Available from: http:// www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM089506.
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7
Guidance on Testosterone. United States Food and Drug Administration. Available from: http://www.fda.gov/ucm/groups/fdagov-public/@fdagovdrugs-gen/documents/document/ucm090592.pdf. R E F E R E N C E S Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, 8 Petrovsky Boulevard, Moscow, 127051, Russian Federation. Adonin VK. 1st category expert of expertise office No 2 of Center of expertise and control of finished pharmaceutical products. Romodanovskiy DP. Chief expert of expertise office No 2 of Center of expertise and control of finished pharmaceutical products. Candidate of Medical Sciences. Niyazov RR. Leading expert of expertise office No 2 of Center of expertise and cont
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8
Draft Guidance on Levothyroxine Sodium. United States Food and Drug Administration. Available from: http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM428208.pdf.
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9
Potassium Chloride Modified-Release Tablets and Capsules: in Vivo Bioequivalence and in Vitro Dissolution Testing. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Available from: http:// www.fda.gov/ohrms/dockets/98fr/02d0307-gdl0002.pdf.
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10
Investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1). European Medicines Agency. Available from: http://www.ema.europa.eu/docs/en_GB/ document_library/Scientific_guideline/2010/01/WC500070039.pdf.
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11
Lopez-Gamboa M, Canales-Gomez JS, Sandoval TJC, Tovar EN, Mejia MA, et al. Bioavailability of Long Acting Capsules of Melatonin in Mexican Healthy Volunteers. J Bioequiv Availab. 2010; 2(5): 116–9.
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12
Sahajwalla CG, Helton ED, Purich ED, Hoppel CL, Cabana BE. Multiple-dose pharmacokinetics and bioequivalence of l-carnitine 330-mg tablet vs. 1-g chewable tablet vs. enteral solution in healthy adult male volunteers. J Pharm Sci. 1995; 84: 627–33.
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13
Jacobsen LV, Rolan P, Christensen MS, Knudsen KM, Rasmussen MH. Bioequivalence between ready-to-use recombinant human growth hormone (rhGH) in liquid formulation and rhGH for reconstitution. Growth Horm IGF Res. 2000; (10): 93–8.
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14
Voortman G, van de Post J, Schoemaker RC, van Gerven JM. Bioequivalence of subcutaneous injections of recombinant human follicle stimulating hormone (Puregon ®) by Pen-injector and syringe. Hum Reprod 1999; (14): 1698–702.
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15
Blakesley VA. Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate. AAPS J 2005; (7): E42–6.
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16
Gisclon LG, Bowen AJ, O’Reilly TE, Lakewold D, Curtin CR, Larson KL, Palmer SA, Natarajan J, Wong FA. Bioequivalence of a newly developed 17 beta-estradiol tablet vs. an identical reference formulation. Arzneimittelforschung 2000; 50: 910–4.
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17
Sanjeeva Dissanayake. Assessing the bioequivalence of analogues of endogenous substances («endogenous drugs»): considerations to optimize study design. Br J Clin Pharmacol 2010; 69: 238–44.
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18
Ромодановский ДП, Соловьева АП, Насонов АС, Кокин ИВ. Особенности планирования и оценки исследований биоэквивалентности эндогенных веществ на примере мелатонина. Ведомости Научного центра экспертизы средств медицинского применения 2014; (4): 17–21.
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19
Хохлов АЛ, Лилеева ЕГ, Синицина ОА, Спешилова СА, Демарина СМ, Шитов ЛН. Проблемы проведения биоаналитической части исследований биоэквивалентности лекарственных препаратов в России. Фармакокинетика и фармакодинамика 2014; (1): 37–43.
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20
Ewerth S, Angelin B, Einarsson K, Nilsell K, Björkhem I. Serum concentrations of ursodeoxycholic acid in portal venous and systemic venous blood of fasting humans as determined by isotope dilution-mass spectrometry. Gastroenterology 1985; 88: 126–33.
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21
Жердев ВП, Колыванов ГБ, Литвин АА, Сариев АК. Гармонизация проведения исследований биоэквивалентности лекарственных препаратов: вопросы и их возможное решение. Экспериментальная и клиническая фармакология 2003; 66(2): 60–64. 8. Draft Guidance on Levothyroxine Sodium. United States Food and Drug Ad-
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