The 7 references with contexts in paper E. Petrova S., D. Goryachev V., M. Petrov V., Е. Петрова С., Д. Горячев В., М. Петров В. (2018) “Современные подходы к оценке биоэквивалентности ингаляционных лекарственных препаратов // Modern approaches to the assessment of orally inhaled products bioequivalence” / spz:neicon:vedomostincesmp:y:2017:i:3:p:135-141

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Global initiative for chronic obstructive lung disease (GOLD) [Internet].
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    ÕÎÁË õàðàêòåðèçóåòñÿ ñòîéêèì îãðàíè÷åíèåì âîçäóøíîãî ïîòîêà, êîòîðîå, êàê ïðàâèëî, ïðîãðåññèðóåò è ñâÿçàíî ñ õðîíè÷åñêîé âîñïàëèòåëüíîé ðåàêöèåé íà âðåäíûå ÷àñòèöû èëè ãàçû â äûõàòåëüíûõ ïóòÿõ (ÄÏ) è ëåãêèõ
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    . Ðàñïðîñòðàíåííîñòü ÁÀ ñîñòàâëÿåò îò 1 äî 18 %, ïî ïîñëåäíèì îöåíêàì ÷èñëî áîëüíûõ áðîíõèàëüíîé àñòìîé â ìèðå ñîñòàâëÿåò áîëåå 334 ìëí ÷åëîâåê.  íàñòîÿùåå âðåìÿ ñàìûìè ýôôåêòèâíûìè ïðåïàðàòàìè äëÿ äëèòåëüíîãî êîíòðîëÿ ñèìïòîìîâ ÁÀ ÿâëÿþòñÿ èíãàëÿöèîííûå ãëþêîêîðòèêîñòåðîèäû (ÈÃÊÑ).

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17 [cited 2017 Jul 3]. Available from: http://www.goldcopd.org. 2. Global Initiative for Asthma (GINA). 2015 [cited 2017 Jul 3]. Available from: http://www.ginasthma.org.
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    ÈÃÊÑ îáëåã÷àþò ñèìïòîìû ÁÀ è óëó÷øàþò êà÷åñòâî æèçíè, óëó÷øàþò ôóíêöèþ ëåãêèõ, óìåíüøàþò ãèïåð÷óâñòâèòåëüíîñòü ÄÏ, ïîçâîëÿþò êîíòðîëèðîâàòü âîñïàëåíèå ÄÏ, óìåíüøèòü ÷àñòîòó è òÿæåñòü îáîñòðåíèé, à òàêæå ñâÿçàííóþ ñ çàáîëåâàíèåì ñìåðòíîñòü
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    . Âòîðîé øèðîêî ïðèìåíÿåìîé ïðè óêàçàííûõ çàáîëåâàíèÿõ ãðóïïîé ëåêàðñòâåííûõ ñðåäñòâ (ËÑ) ÿâëÿþòñÿ áðîíõîäèëàòàòîðû. Èíãàëÿöèîííûå áðîíõîäèëàòàòîðû òàêæå èñïîëüçóþòñÿ ïðè ëå÷åíèè ÁÀ è èãðàþò öåíòðàëüíóþ ðîëü â ëå÷åíèè áîëüíûõ ñ ÕÎÁË.

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Mitkina LI, Kovaleva EL, Prokopov IA. Standardization of inhalation dosage forms in the Russian Federation: current status and perspectives. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2012; (1): 53–7 (in Russian).
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     òî æå âðåìÿ ñîâðåìåííûå ïîäõîäû ê ñòàíäàðòèçàöèè èíãàëÿöèîííûõ ËÏ, âêëþ÷àþùèå íàó÷íî è ýêñïåðèìåíòàëüíî îáîñíîâàííóþ íîðìàòèâíóþ áàçó äëÿ âûïóñêà è êîíòðîëÿ êà÷åñòâà ëåêàðñòâåííûõ ïðåïàðàòîâ äëÿ èíãàëÿöèé (â ÷àñòíîñòè, èññëåäîâàíèå èõ àýðîäèíàìè÷åñêèõ ïîêàçàòåëåé), íàøëè îòðàæåíèå â XIII èçäàíèè Ãîñóäàðñòâåííîé ôàðìàêîïåè Ðîññèéñêîé Ôåäåðàöèè
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    . Óñòàíîâëåíèå ýêâèâàëåíòíîñòè âîñïðîèçâåäåííûõ èíãàëÿöèîííûõ ïðåïàðàòîâ (ÈÏ) çà÷àñòóþ ÿâëÿåòñÿ ñëîæíîé çàäà÷åé. Ìåòîäîëîãèÿ îïðåäåëåíèÿ áèîýêâèâàëåíòíîñòè íàèáîëåå äåòàëüíî ðåãëàìåíòèðîâàíà äëÿ ñèñòåìíî äåéñòâóþùèõ òâåðäûõ ïåðîðàëüíûõ ëåêàðñòâåííûõ ôîðì.

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General monograph 1.4.2.001.15. Aerodynamic particle size distribution.State Pharmacopoeia of the Russian Federation. XIII ed. Ì.; 2015. Available from: http:// femb.ru/feml.
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    Äîëæíà áûòü ïðîäåìîíñòðèðîâàíà ñîïîñòàâèìîñòüin vitroäëÿ ðàçíûõ äîç ïðåïàðàòîâ. Â íàñòîÿùåå âðåìÿ íàèáîëåå øèðîêî èñïîëüçóåòñÿ äâîéíîé ñëåïîé, ðàíäîìèçèðîâàííûé â ïàðàëëåëüíûõ ãðóïïàõ äèçàéí èññëåäîâàíèÿ äëÿ ñðàâíåíèÿ èññëåäóåìîãî è ðåôåðåíòíîãî ïðåïàðàòîâ
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    ; åñëè âûáðàííûé äèçàéí èññëåäîâàíèÿ îòëè÷àåòñÿ îò óêàçàííîãî, ïðè÷èíû ýòîãî äîëæíû áûòü îáîñíîâàíû çàÿâèòåëåì. Ïðè èññëåäîâàíèè òåðàïåâòè÷åñêîé ýêâèâàëåíòíîñòè ÈÃÊÑ òàêæå èñïîëüçóþòñÿ äâå ôàðìàêîäèíàìè÷åñêèå ìîäåëè, îäíàêî áðîíõîïðîòåêòèâíàÿ — ñóùåñòâåííî ðåæå ââèäó ìåíüøåãî îïûòà.

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European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents Doc. Ref. CPMP/EWP/4151/00 Rev. 1. London; 2009. Available from: https:// goo.gl/ZzEkwi.
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    ñèñòåìíàÿ ôàðìàêîêèíåòèêà è ëåãî÷íîå ðàñïðåäåëåíèå, ýêâèâàëåíòíûå ôàðìàêîäèíàìè÷åñêèå ñâîéñòâà è êëèíè÷åñêèé ýôôåêò) ìîæåò ïîçâîëèòü ñîñòàâèòü ïðåäñòàâëåíèå î ñâîéñòâàõ ïðåäëàãàåìîãî íîâîãî ïðåïàðàòà. Óñòàíîâëåíèå ýêâèâàëåíòíîñòè ÈÏ, ñîãëàñíî ñîâðåìåííûì òðåáîâàíèÿì, ïðåäïîëàãàåò ñòóïåí÷àòûé ïîäõîä ê îïðåäåëåíèþ áèîýêâèâàëåíòíîñòè «îðèãèíàëüíîãî »è âîñïðîèçâåäåííîãî èíãàëÿòîðîâ
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    , à èìåííî: – îöåíêà ýêâèâàëåíòíîñòè êà÷åñòâåííîãî è êîëè÷åñòâåííîãî ñîñòàâà äåéñòâóþùåãî è âñïîìîãàòåëüíûõ âåùåñòâ ñðàâíèâàåìûõ ïðåïàðàòîâ è ñõîäñòâà ñâîéñòâ èñïîëüçóåìîãî ñðåäñòâà äîñòàâêè; – èçó÷åíèå ñðàâíèòåëüíûõ äàííûõ èíãàëÿòîðàin vitroñ ïîëó÷åíèåì äàííûõ ðàñïðåäåëåíèÿ ðàçìåðîâ ÷àñòèö âäûõàåìîé äîçû; – èçó÷åíèå ñèñòåìíîé ôàðìàêîêèíåòèêè è ëåãî÷íîãî ðàñïðåäåëåíèÿ; – îöåíêà ôàðìàêîäèíàìè÷åñêèõ

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Olefir YuV. The results of the analysis on materials of safety of clinical trials. Safety and Risk of Pharmacotherapy 2017; 5(1): 5–10 (in Russian).
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    Åñëè ââîäÿò íîâûé ïðîïåëëåíò, âñïîìîãàòåëüíîå âåùåñòâî èëè êîìáèíàöèþ âñïîìîãàòåëüíûõ âåùåñòâ, òî â äîïîëíåíèå ê ñòàíäàðòíîé òîêñèêîëîãè÷åñêîé è äîêëèíè÷åñêîé ïðîãðàììàì äîëæíî áûòü èçó÷åíî èõ âîçìîæíîå âëèÿíèå íà êëèíè÷åñêóþ ýôôåêòèâíîñòü è áåçîïàñíîñòü. Ìîãóò áûòü íåîáõîäèìû ðàñøèðåííûå äàííûå î áåçîïàñíîñòè
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    .  ðàìêàõ ýêñïåðòèçû äîëæíà áûòü ïîäòâåðæäåíà òåðàïåâòè÷åñêàÿ ýêâèâàëåíòíîñòü äëÿ âîñïðîèçâåäåííûõ ïðåïàðàòîâ.  íåêîòîðûõ ñëó÷àÿõ èñïîëüçîâàíèå òîëüêî ñðàâíèòåëüíûõ äàííûõin vitro, ïîëó÷åííûõ ñ ïîìîùüþ ñòàíäàðòíûõ ìåòîäîâ (òàêèõ êàê ìíîãîñòóïåí÷àòûé êàñêàäíûé èìïàêòîð/èìïèíæåð), ìîæåò ñ÷èòàòüñÿ ïðèåìëåìûì, åñëè ïðåïàðàò óäîâëåòâîðÿåò âñåì ïðåäñòàâëåííûì êðèòåðèÿì (â ñðàâíåíèè ñ ðåôåðåíòíûì ï

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Nonikov VE, Arkhipov VV, Marinin VF, Cheltsov VV, Berdnikova NG, Petrova ES. Guideline on conducting clinical trials of inhaled glucocorticosteroids. In: Guidance on clinical evaluation of medicines. Part I. Moscow: Grif i K; 2012. P. 177–86 (in Russian). AUTHORS
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    Åñëè ââîäÿò íîâûé ïðîïåëëåíò, âñïîìîãàòåëüíîå âåùåñòâî èëè êîìáèíàöèþ âñïîìîãàòåëüíûõ âåùåñòâ, òî â äîïîëíåíèå ê ñòàíäàðòíîé òîêñèêîëîãè÷åñêîé è äîêëèíè÷åñêîé ïðîãðàììàì äîëæíî áûòü èçó÷åíî èõ âîçìîæíîå âëèÿíèå íà êëèíè÷åñêóþ ýôôåêòèâíîñòü è áåçîïàñíîñòü. Ìîãóò áûòü íåîáõîäèìû ðàñøèðåííûå äàííûå î áåçîïàñíîñòè
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    .  ðàìêàõ ýêñïåðòèçû äîëæíà áûòü ïîäòâåðæäåíà òåðàïåâòè÷åñêàÿ ýêâèâàëåíòíîñòü äëÿ âîñïðîèçâåäåííûõ ïðåïàðàòîâ.  íåêîòîðûõ ñëó÷àÿõ èñïîëüçîâàíèå òîëüêî ñðàâíèòåëüíûõ äàííûõin vitro, ïîëó÷åííûõ ñ ïîìîùüþ ñòàíäàðòíûõ ìåòîäîâ (òàêèõ êàê ìíîãîñòóïåí÷àòûé êàñêàäíûé èìïàêòîð/èìïèíæåð), ìîæåò ñ÷èòàòüñÿ ïðèåìëåìûì, åñëè ïðåïàðàò óäîâëåòâîðÿåò âñåì ïðåäñòàâëåííûì êðèòåðèÿì (â ñðàâíåíèè ñ ðåôåðåíòíûì ï