The 19 references in paper D. Romodanovsky P., D. Goryachev V., Д. Ромодановский П., Д. Горячев В. (2018) “Планирование и оценка исследований биоэквивалентности препаратов розувастатина // Planning and evaluation of bioequivalence studies of rosuvastatin drug products” / spz:neicon:vedomostincesmp:y:2017:i:3:p:142-149

1
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Jones PH, Hunninghake DB, Ferdinand KC, Stein EA, Gold A, Caplan RJ, et al. Effects of rosuvastatin versus atorvastatin, simvastatin, and pravastatin on non-high-density lipoprotein cholesterol, apolipoproteins, and lipid ratios in patients with hypercholesterolemia: additional results from the STELLAR Trial. Clin Ther. 2004; 26(9): 1388–99.
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The Federal Law of the Russian Federation of 12.04.2010 No. 61-FZ «On Circulation of Medicines». Available from: https://goo.gl/sUorrH (in Russian).
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The Federal Law of the Russian Federation of 22.12.2014 No. 429-FZ «On Amendments to the Federal Law «On Circulation of Medicines». Available from: https://goo.gl/sUorrH (in Russian).
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5
The Federal Law of the Russian Federation of 13.07.2015 No. 241-FZ «On Amendments to the Federal Law «On Circulation of Medicines» and the Federal Law «On Amendments to the Federal Law «On Circulation of Medicines». Available from: https://goo.gl/ vNC34n (in Russian).
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Romodanovsky DP, Dranitsyna MA, Goryachev DV, Niyazov RR, Gavrishina EV. Design planning and evaluation of bioequivalence results of highly variable preparations based on rosuvastatin. Experimental and Clinical Pharmacology 2015; 78(6): 19–25 (in Russian).
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Romodanovsky DP, Eremenkova TV, Dranitsyna MA, Goryachev DV, Niyazov RR, Gavrishina EV, et al. Highly variable medicines — specific aspects of bioequivalence studies. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2015; (4): 5–10 (in Russian).
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Instructions for the use of a medicinal product Crestor® [Internet]. [cited 2016 Oct 20]. Available from: https://goo.gl/qcvF3U (in Russian).
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Singh SS, Sharma K, Patel H, Jain M, Shah H, Gupta S, et al. Estimation of rosuvastatin in human plasma by HPLC tandem mass spectroscopic method and its application to bioequivalence study. J Braz Chem Soc. 2005; 16(5): 944–50.
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Thota S, Tippabhotla SK, Khan S, Nakkawar M. Two-way crossover bioequivalence study of rosuvastatin tablets 5 mg in healthy, adult, asian-indian male volunteers under fasting condition. Int J Pharm Pharm Sci 2013; 5(3): 289–93.
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12
Zhang D, Zhang J, Liu X, Wei C, Zhang R, Song H, et al. Validated LC-MS/MS method for the determination of rosuvastatin in human plasma: application to a bioequivalence study in Chinese volunteers. Pharmacology & Pharmacy 2011; 2(4): 341–6.
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Public Assessment Report Rosuvastatine Torrent 5 mg, 10 mg, 20 mg and 40 mg, film-coated tablets (rosuvastatin calcium). Available from: https:// goo.gl/LZyHVs.
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Vargas M, Bustamante C, Villarraga E. Bioequivalence study of two formulations containing rosuvastatin 40 mg tablets in healthy colombians. J Bioequiv Availab 2015; (7): 229–32.
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15
Trabelsi F, Bartunek A, Vlavonou R, Navratilova L, Dube C., Tanguay M, et al. Single-dose, 2-way crossover, bioequivalence study of two rosuvastatin formulations in normal healthy subjects under fasting conditions. Int J Clin Pharmacol Ther 2013; 50(10): 741–50.
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16
HarahapY, Prasaja B, Azmi F, Lusthom W, Sinandang T, Felicia V, et al. Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects. Int J Clin Pharmacol Ther 2016; 54(3): 212–6.
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17
Davit BM, Chen ML, Conner DP, Haidar SH, Kim S, Lee CH, et al. Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration. AAPS J. 2012; 14(4): 915–24.
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18
Guidance on evaluation of medicines. V. I. Moscow: Grif i K; 2013 (in Russian).
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19
Rules for bioequivalence studies of drugs of the Eurasian Economic Union. Available from: https://goo.gl/j5Kunj (in Russian). AUTHORS Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, Petrovsky boulevard 8, bld. 2, Moscow 127051, Russian Federation.
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