The 10 references with contexts 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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    Âåäîìîñòè Íàó÷íîãî öåíòðà ýêñïåðòèçû ñðåäñòâ ìåäèöèíñêîãî ïðèìåíåíèÿ 2016; (4): 36–41. Îäíèì èç öåëåâûõ íàïðàâëåíèé ðàçâèòèÿ ðîññèéñêîé ôàðìàöåâòè÷åñêîé ïðîìûøëåííîñòè íà 2013–2020 ãîäû ÿâëÿåòñÿ ðàçðàáîòêà ñëåäóþùèõ â êëàññå ïðåïàðàòîâ (ïðåïàðàòû «next-in-class »èëè «me-too»)
    Exact
    [1, 2]
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    . Ýòî îðèãèíàëüíûå çàùèùåííûå ïàòåíòîì ïðåïàðàòû, äåéñòâóþùèå íà èçâåñòíûå áèîìèøåíè è ïî ñòðóêòóðå è ìåõàíèçìó äåéñòâèÿ íàïîìèíàþùèå óæå ñóùåñòâóþùèå óñïåøíî çàðåêîìåíäîâàâøèå ñåáÿ ïðåïàðàòû.  îòëè÷èå îò ðàçðàáîòêè èííîâàöèîííûõ ëåêàðñòâåííûõ ñðåäñòâ ñ íîâûì ìåõàíèçìîì äåéñòâèÿ, ðàçðàáîòêó ïðåïàðàòà «next-inclass »ìîæíî îòíåñòè ê ìàëîðèñêîâûì R&D ñòðàòåãèÿì, â ïåðâóþ î÷åðåäü áëàãîäàðÿ áîëåå âûñî

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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    Âåäîìîñòè Íàó÷íîãî öåíòðà ýêñïåðòèçû ñðåäñòâ ìåäèöèíñêîãî ïðèìåíåíèÿ 2016; (4): 36–41. Îäíèì èç öåëåâûõ íàïðàâëåíèé ðàçâèòèÿ ðîññèéñêîé ôàðìàöåâòè÷åñêîé ïðîìûøëåííîñòè íà 2013–2020 ãîäû ÿâëÿåòñÿ ðàçðàáîòêà ñëåäóþùèõ â êëàññå ïðåïàðàòîâ (ïðåïàðàòû «next-in-class »èëè «me-too»)
    Exact
    [1, 2]
    Suffix
    . Ýòî îðèãèíàëüíûå çàùèùåííûå ïàòåíòîì ïðåïàðàòû, äåéñòâóþùèå íà èçâåñòíûå áèîìèøåíè è ïî ñòðóêòóðå è ìåõàíèçìó äåéñòâèÿ íàïîìèíàþùèå óæå ñóùåñòâóþùèå óñïåøíî çàðåêîìåíäîâàâøèå ñåáÿ ïðåïàðàòû.  îòëè÷èå îò ðàçðàáîòêè èííîâàöèîííûõ ëåêàðñòâåííûõ ñðåäñòâ ñ íîâûì ìåõàíèçìîì äåéñòâèÿ, ðàçðàáîòêó ïðåïàðàòà «next-inclass »ìîæíî îòíåñòè ê ìàëîðèñêîâûì R&D ñòðàòåãèÿì, â ïåðâóþ î÷åðåäü áëàãîäàðÿ áîëåå âûñî

3
Gagne JJ, Choudhry NK. How many «me-too» drugs is too many? JAMA 2011; 305(7): 711–2.
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    Òåì íå ìåíåå, êëàññè÷åñêèì ïîäõîäîì ê ðàçðàáîòêå ïðåïàðàòîâ «nextin-class »ÿâëÿåòñÿ ïîâòîðåíèå êëèíè÷åñêîé ïðîãðàììû èííîâàöèîííîãî ëåêàðñòâà, ÷òî çà÷àñòóþ òðåáóåò íå ìåíüøèõ èíâåñòèöèîííûõ âëîæåíèé è íå ïîçâîëÿåò çíà÷èìî ñíèçèòü ñòîèìîñòü âûâîäèìûõ íà ðûíîê ïðåïàðàòîâ-àíàëîãîâ
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    . Òàêèì îáðàçîì, ïåðåä ôàðìðàçðàáîò÷èêàìè ñòîèò çàäà÷à ýôôåêòèâíîãî ïëàíèðîâàíèÿ ïðîãðàììû êëèíè÷åñêèõ èññëåäîâàíèé ïðåïàðàòîâ «next-inclass »ñ öåëüþ îáåñïå÷åíèÿ èõ ïðèåìëåìîé ñòîèìîñòè è ñêîðåéøåãî âûâåäåíèÿ íà ðûíîê.

4
Heike Fell, Adaptive Design Clinical Trials, Master of Drug Regulatory Affairs. Bonn; 2014.
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    èííîâàöèîííûõ ïîäõîäîâ, êîòîðûé ïîçâîëÿåò ïðîâîäèòü êëèíè÷åñêèå èññëåäîâàíèÿ áîëåå ýôôåêòèâíî (â áîëåå êîðîòêèå ñðîêè, ñ âêëþ÷åíèåì ìåíüøåãî ÷èñëà ïàöèåíòîâ è ò.ï.) èëè ïîâûøàòü âåðîÿòíîñòü äåìîíñòðàöèè ýôôåêòà ïðåïàðàòà.  òàêèõ èññëåäîâàíèÿõ ïðåäâàðèòåëüíî çàïëàíèðîâàíà âîçìîæíîñòü ìîäèôèöèðîâàòü êàêîé-ëèáî àñïåêò äèçàéíà èëè ãèïîòåçû íà îñíîâàíèè ïðîìåæóòî÷íîãî àíàëèçà ïîëó÷åííûõ äàííûõ
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    . Ñóùåñòâóþùèé â ìèðå èíòåðåñ ê ìåòîäîëîãèè àäàïòèâíîãî äèçàéíà ñî ñòîðîíû èíäóñòðèè îáóñëîâëåí â ïåðâóþ î÷åðåäü ïîòåíöèàëüíîé âîçìîæíîñòüþ îïòèìèçèðîâàòü ðàçðàáîòêó ïðåïàðàòîâ ïî ñðàâíåíèþ ñ êëàññè÷åñêèì íåàäàïòèâíûì ïîäõîäîì [7].

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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    äèçàéíà, îäíàêî âûðàæàþò áåñïîêîéñòâî ïî ïîâîäó íåêîòîðûõ àñïåêòîâ òàêîãî ïîäõîäà, â ïåðâóþ î÷åðåäü â îòíîøåíèè âîçìîæíîãî óâåëè÷åíèÿ ðèñêà èñêàæåíèé è ñèñòåìíûõ îøèáîê (bias) è, êàê ñëåäñòâèå, íåïðàâèëüíîé èíòåðïðåòàöèè ðåçóëüòàòîâ èññëåäîâàíèé. Êðîìå òîãî, îïðåäåëåííóþ ñëîæíîñòü âûçûâàåò âûáîð ñòàòèñòè÷åñêèõ ìåòîäèê äëÿ îáåñïå÷åíèÿ öåëîñòíîñòè è äîñòîâåðíîñòè äàííûõ â òàêèõ èññëåäîâàíèÿõ
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    . Òåì íå ìåíåå, òùàòåëüíî ñïëàíèðîâàííûå êëèíè÷åñêèå èññëåäîâàíèÿ, âêëþ÷àþùèå ýëåìåíòû àäàïòèâíîãî äèçàéíà ñ ïðåäâàðèòåëüíî çàïëàíèðîâàííîé ìîäèôèêàöèåé èçó÷àåìûõ ïàðàìåòðîâ íà îñíîâàíèè ïðîìåæóòî÷íîãî àíàëèçà äàííûõ, ìîãóò ïîâûñèòü ýôôåêòèâíîñòü ñàìèõ èññëåäîâàíèé è ìèíèìèçèðîâàòü ðèñê ïîëó÷åíèÿ îøèáî÷íûõ ðåçóëüòàòîâ.

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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    äèçàéíà, îäíàêî âûðàæàþò áåñïîêîéñòâî ïî ïîâîäó íåêîòîðûõ àñïåêòîâ òàêîãî ïîäõîäà, â ïåðâóþ î÷åðåäü â îòíîøåíèè âîçìîæíîãî óâåëè÷åíèÿ ðèñêà èñêàæåíèé è ñèñòåìíûõ îøèáîê (bias) è, êàê ñëåäñòâèå, íåïðàâèëüíîé èíòåðïðåòàöèè ðåçóëüòàòîâ èññëåäîâàíèé. Êðîìå òîãî, îïðåäåëåííóþ ñëîæíîñòü âûçûâàåò âûáîð ñòàòèñòè÷åñêèõ ìåòîäèê äëÿ îáåñïå÷åíèÿ öåëîñòíîñòè è äîñòîâåðíîñòè äàííûõ â òàêèõ èññëåäîâàíèÿõ
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    . Òåì íå ìåíåå, òùàòåëüíî ñïëàíèðîâàííûå êëèíè÷åñêèå èññëåäîâàíèÿ, âêëþ÷àþùèå ýëåìåíòû àäàïòèâíîãî äèçàéíà ñ ïðåäâàðèòåëüíî çàïëàíèðîâàííîé ìîäèôèêàöèåé èçó÷àåìûõ ïàðàìåòðîâ íà îñíîâàíèè ïðîìåæóòî÷íîãî àíàëèçà äàííûõ, ìîãóò ïîâûñèòü ýôôåêòèâíîñòü ñàìèõ èññëåäîâàíèé è ìèíèìèçèðîâàòü ðèñê ïîëó÷åíèÿ îøèáî÷íûõ ðåçóëüòàòîâ.

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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    Ñóùåñòâóþùèé â ìèðå èíòåðåñ ê ìåòîäîëîãèè àäàïòèâíîãî äèçàéíà ñî ñòîðîíû èíäóñòðèè îáóñëîâëåí â ïåðâóþ î÷åðåäü ïîòåíöèàëüíîé âîçìîæíîñòüþ îïòèìèçèðîâàòü ðàçðàáîòêó ïðåïàðàòîâ ïî ñðàâíåíèþ ñ êëàññè÷åñêèì íåàäàïòèâíûì ïîäõîäîì
    Exact
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    . Àäàïòèâíûé èííîâàöèîííûé ïîäõîä ìîæåò ïðèâåñòè ê áîëåå ýôôåêòèâíîìó ïîëó÷åíèþ äàííûõ, ïîâûøåíèþ âåðîÿòíîñòè óñïåõà â äîñòèæåíèè öåëåé èññëåäîâàíèÿ è óëó÷øåíèþ ïîíèìàíèÿ ýôôåêòîâ èññëåäóåìîãî ïðåïàðàòà.

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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    ÐÅÇÓËÜÒÀÒÛ È ÎÁÑÓÆÄÅÍÈÅ SRX-1374-02— «Ìíîãîöåíòðîâîå îòêðûòîå ðàíäîìèçèðîâàííîå êëèíè÷åñêîå èññëåäîâàíèå ýôôåêòèâíîñòè è áåçîïàñíîñòè Ãîñîãëèïòèíà â êà÷åñòâå ìîíîòåðàïèè è â êîìáèíàöèè ñ Ìåòôîðìèíîì ïî ñðàâíåíèþ ñ Âèëäàãëèïòèíîì â êà÷åñòâå ìîíîòåðàïèè è â êîìáèíàöèè ñ Ìåòôîðìèíîì ó ïàöèåíòîâ ñ ñàõàðíûì äèàáåòîì 2 òèïà, ðàíåå íå ïîëó÷àâøèõ ëåêàðñòâåííîé òåðàïèè »
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    .  èññëåäîâàíèå áûëî âêëþ÷åíî 299 ïàöèåíòîâ, ïîäïèñàâøèõ èíôîðìèðîâàííîå ñîãëàñèå: 149 ïàöèåíòîâ â ãðóïïó Ãîñîãëèïòèíà è 150 ïàöèåíòîâ â ãðóïïó Âèëäàãëèïòèíà. Ïðîìåæóòî÷íûé àíàëèç äàííûõ, ïîëó÷åííûõ îò ïàöèåíòîâ íà íåäåëå 12 èññëåäîâàíèÿ (ýòàï ìîíîòåðàïèè), ïîêàçàë, ÷òî â ãðóïïå Ãîñîãëèïòèíà ñíèæåíèå HbA1c ñîñòàâèëî ìèíóñ 0,93 %, à â ãðóïïå Âèëäàãëèïòèíà ìèíóñ 1,03 %.

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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    CV-TRX-01— «Ìíîãîöåíòðîâîå ðàíäîìèçèðîâàííîå ïèëîòíîå êëèíè÷åñêîå èññëåäîâàíèå äëÿ ïîäáîðà îïòèìàëüíûõ äîçèðîâîê è îöåíêè áåçîïàñíîñòè è ýôôåêòèâíîñòè ïðÿìîãî èíãèáèòîðà Xa ôàêòîðà Òèàðåêñà ïî ñðàâíåíèþ ñ Ýíîêñàïàðèíîì â êà÷åñòâå ñðåäñòâà ïðîôèëàêòèêè âåíîçíûõ òðîìáîýìáîëè÷åñêèõ îñëîæíåíèé ïðè ïðîòåçèðîâàíèè êîëåííîãî ñóñòàâà »
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    . Íà ïåðâîì ýòàïå â èññëåäîâàíèå áûëî âêëþ÷åíî 92 ïàöèåíòà, ïîäïèñàâøèõ èíôîðìèðîâàííîå ñîãëàñèå, â òîì ÷èñëå ïî 23 ïàöèåíòà â ãðóïïû Òèàðåêñàáàíà, íàçíà÷àåìîãî â äîçàõ 50 ìã è 150 ìã (ñîîòâåòñòâåííî), 22 ïàöèåíòà â ãðóïïó Òèàðåêñàáàíà, íàçíà÷àåìîãî â äîçå 100 ìã, è 24 ïàöèåíòà â ãðóïïó Ýíîêñàïàðèíà, íàçíà÷àåìîãî â äîçå 40 ìã ïîäêîæíî.

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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    îøèáêè,d— ãðàíèöà íåóñòóïàþùåé ýôôåêòèâíîñòè,r— ìàêñèìàëüíî äîïóñòèìîå ÷èñëî ñëó÷àåâ,n— ÷èñëî ïàöèåíòîâ. ïîäáîðà îïòèìàëüíîé äîçèðîâêè ïðåïàðàòà VM-1500 â ñðàâíåíèè ñ ïðåïàðàòîì Ýôàâèðåíç íà ôîíå ñòàíäàðòíîé áàçèñíîé àíòèðåòðîâèðóñíîé òåðàïèè, ñîñòîÿùåé èç äâóõ íóêëåîçèäíûõ/íóêëåîòèäíûõ èíãèáèòîðîâ îáðàòíîé òðàíñêðèïòàçû, ó ÂÈ×-1-èíôèöèðîâàííûõ ïàöèåíòîâ, ðàíåå íå ïîëó÷àâøèõ ëå÷åíèÿ »
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    . Íà ïåðâîì ýòàïå â èññëåäîâàíèå áûëî âêëþ÷åíî 90 ïàöèåíòîâ, ïîäïèñàâøèõ èíôîðìèðîâàííîå ñîãëàñèå, — ïî 30 ïàöèåíòîâ â ãðóïïû Ýëïèâèðèíà 20 ìã, 40 ìã è â ãðóïïó Ýôàâèðåíçà 600 ìã. Ïðîìåæóòî÷íûé àíàëèç ïîêàçàë, ÷òî â ãðóïïå Ýëïèâèðèíà 20 ìã 93,3 % ïàöèåíòîâ äîñòèãëè öåëåâîãî óðîâíÿ âèðóñíîé íàãðóçêè íà íåäåëå 12, â ãðóïïå Ýëïèâèðèíà 40 ì㠗 86,2 %, â ãðóïïå Ýôàâèðåíçà — 81,5 %.