The 10 references in paper N. Vostokova V., Yu. Trakhtenberg A., E. Smolyarchuk A., A. Svistunov A., Н. Востокова В., Ю. Трахтенберг А., Е. Смолярчук А., А. Свистунов А. (2018) “Возможности применения адаптивного дизайна в клинических исследованиях препаратов «next-in-class» // Possibilities of adaptive design implementation in clinical trials of next-in-class drugs” / spz:neicon:vedomostincesmp:y:2016:i:4:p:36-41

1
Decree of the Government of the Russian Federation, 17.02.2011, ¹ 91 «On the federal target program «Development of the Pharmaceutical and Medical Industry of the Russian Federation for the period up to 2020 and beyond» (in Russian).
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2
Decree of the Government of the Russian Federation, 30.12.2015, ¹ 1503 «On approval of rules for granting subsidies from the federal budget of the Russian organizations for reimbursement of expenses for implementation of development projects similar in pharmaceuticals and improvedanalogues of innovative medicines» (in Russian).
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3
Gagne JJ, Choudhry NK. How many «me-too» drugs is too many? JAMA 2011; 305(7): 711–2.
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4
Heike Fell, Adaptive Design Clinical Trials, Master of Drug Regulatory Affairs. Bonn; 2014.
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5
Guidance for Industry Adaptive Design Clinical Trials for Drugs and Biologics, Draft Guidance, U. S. Department of Health and Human Services FDA, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), February 2010. P. 1–50.
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6
Committee for Medicinal Products for Human Use (CHMP), Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. London, 18 October 2007 (Doc. Ref. CHMP/EWP/2459/02).
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7
Food and Drug Administration. Innovative/stagnation: Challenge and opportunity in the critical path to new medical products. FDA report 2004. Available from: http:// www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.
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8
Galstyan KO, Nedosugova LV, Petunina NA, Trakhtenberg YuA., Vostokova NV, Karavaeva OV, et al. Comparison of the novel Russian DPP-4 inhibitor gosogliptin with vildagliptin in patients with type 2 diabetes mellitus. Saharny diabet 2016; 19(1): 89–96 (in Russian).
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9
Zamyatin MN, Vostokova NV, Trakhtenberg YuA, Krivonos NV, Stoyko YuM, Zagrekov VI, et al. New national anticoagulant Tiarexaban — inhibitor of Xa factor. Tromboz, gemostaz i reologiya 2015; 4(64): 36–44 (in Russian).
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10
Kravchenko AV, Orlova-Morozova EA, Shimonova TE, Kozyrev OA, Nagimova FI, Bychko VV, et al. The efficacy and safety of a new russian HIV non-nucleoside reverse transcriptase inhibitor (VM-1500, Elpivirine) as a component in an antiretroviral therapy regimen. Epidemiologiya i infektsionnye bolezni 2015; (5): 58–64 (in Russian).
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