The 15 references with contexts 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
Jones PH, Davidson MH, Stein EA, Bays HE, McKenney JM, Miller A, et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR*Trial). Am J Cardiol. 2003; 92(2): 152–160.
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    Îäíèì èç ïðåäñòàâèòåëåé äàííîé ãðóïïû ïðåïàðàòîâ ÿâëÿåòñÿ ðîçóâàñòàòèí, êîòîðûé ñ÷èòàåòñÿ áîëåå «ìîùíûì »â ëèïèäñíèæàþùåì äåéñòâèè ïî ñðàâíåíèþ ñ êëàññè÷åñêèìè, õîðîøî çàðåêîìåíäîâàâøèìè ñåáÿ â êëèíè÷åñêîé ïðàêòèêå ñòàòèíàìè (àòîðâàñòàòèí è ñèìâàñòàòèí)
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    . Ïðîâåäåíèå èññëåäîâàíèé áèîýêâèâàëåíòíîñòè â ñðàâíåíèè ñ çàðåãèñòðèðîâàííûì ðåôåðåíòíûì ïðåïàðàòîì (çà èñêëþ÷åíèåì ïðåïàðàòîâ, äëÿ êîòîðûõ ïðîâåäåíèå äàííîãî èññëåäîâàíèÿ íåâîçìîæíî) ÿâëÿåòñÿ òðåáîâàíèåì ê ðåãèñòðàöèè äëÿ áîëüøèíñòâà âîñïðîèçâåäåííûõ ïðåïàðàòîâ [3–5].

2
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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    Îäíèì èç ïðåäñòàâèòåëåé äàííîé ãðóïïû ïðåïàðàòîâ ÿâëÿåòñÿ ðîçóâàñòàòèí, êîòîðûé ñ÷èòàåòñÿ áîëåå «ìîùíûì »â ëèïèäñíèæàþùåì äåéñòâèè ïî ñðàâíåíèþ ñ êëàññè÷åñêèìè, õîðîøî çàðåêîìåíäîâàâøèìè ñåáÿ â êëèíè÷åñêîé ïðàêòèêå ñòàòèíàìè (àòîðâàñòàòèí è ñèìâàñòàòèí)
    Exact
    [1, 2]
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    . Ïðîâåäåíèå èññëåäîâàíèé áèîýêâèâàëåíòíîñòè â ñðàâíåíèè ñ çàðåãèñòðèðîâàííûì ðåôåðåíòíûì ïðåïàðàòîì (çà èñêëþ÷åíèåì ïðåïàðàòîâ, äëÿ êîòîðûõ ïðîâåäåíèå äàííîãî èññëåäîâàíèÿ íåâîçìîæíî) ÿâëÿåòñÿ òðåáîâàíèåì ê ðåãèñòðàöèè äëÿ áîëüøèíñòâà âîñïðîèçâåäåííûõ ïðåïàðàòîâ [3–5].

3
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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    Ïðîâåäåíèå èññëåäîâàíèé áèîýêâèâàëåíòíîñòè â ñðàâíåíèè ñ çàðåãèñòðèðîâàííûì ðåôåðåíòíûì ïðåïàðàòîì (çà èñêëþ÷åíèåì ïðåïàðàòîâ, äëÿ êîòîðûõ ïðîâåäåíèå äàííîãî èññëåäîâàíèÿ íåâîçìîæíî) ÿâëÿåòñÿ òðåáîâàíèåì ê ðåãèñòðàöèè äëÿ áîëüøèíñòâà âîñïðîèçâåäåííûõ ïðåïàðàòîâ
    Exact
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    .  ñâîåé ïðåäûäóùåé ñòàòüå ìû óæå îñòàíàâëèâàëèñü íà ïðîáëåìàõ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè ïðåïàðàòîâ ðîçóâàñòàòèíà, â ÷àñòíîñòè íà âîçìîæíîé âûñîêîé âàðèàáåëüíîñòè ôàðìàêîêèíåòè÷åñêèõ ïàðàìåòðîâ ðîçóâàñòàòèíà â èññëåäîâàíèÿõ áèîýêâèâàëåíòíîñòè [6].

6
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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     ñâîåé ïðåäûäóùåé ñòàòüå ìû óæå îñòàíàâëèâàëèñü íà ïðîáëåìàõ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè ïðåïàðàòîâ ðîçóâàñòàòèíà, â ÷àñòíîñòè íà âîçìîæíîé âûñîêîé âàðèàáåëüíîñòè ôàðìàêîêèíåòè÷åñêèõ ïàðàìåòðîâ ðîçóâàñòàòèíà â èññëåäîâàíèÿõ áèîýêâèâàëåíòíîñòè
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    . Ïî ðåçóëüòàòàì ïðîâåäåííîãî àíàëèçà ìû ïðåäïîëîæèëè, ÷òî â îòñóòñòâèå íàäåæíûõ äàííûõ, îïðîâåðãàþùèõ âûñîêóþ âàðèàáåëüíîñòü ïðåïàðàòîâ ðîçóâàñòàòèíà, öåëåñîîáðàçíî ïðåäóñìàòðèâàòü äèçàéí èññëåäîâàíèé áèîýêâèâàëåíòíîñòè, êàê äëÿ âûñîêîâàðèàáåëüíûõ ïðåïàðàòîâ.

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    êîýôôèöèåíò âíóòðèèíäèâèäóàëüíîé âàðèàáåëüíîñòè (CVintra)îäíîãî èç äâóõ îñíîâíûõ ïàðàìåòðîâ áèîýêâèâàëåíòíîñòè (ìàêñèìàëüíàÿ êîíöåíòðàöèÿ â êðîâè (Cmax)è ïëîùàäü ïîä êðèâîé «êîíöåíòðàöèÿ–âðåìÿ »(AUC)) ñîñòàâëÿåò³30 %. Äðóãèìè ñëîâàìè, ýòî ïðåïàðàòû, ñêîðîñòü è ñòåïåíü âñàñûâàíèÿ êîòîðûõ äåìîíñòðèðóþò âûñîêóþ âàðèàáåëüíîñòü ó îäíîãî è òîãî æå ñóáúåêòà ïðè ïðèåìå ËÏ â îäèíàêîâîé äîçèðîâêå
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    . Öåëü ðàáîòû — ðåòðîñïåêòèâíûé àíàëèç ðåçóëüòàòîâ ïðîâåäåííûõ ýêñïåðòèç îò÷åòîâ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè, ïîñòóïàâøèõ íà ðåãèñòðàöèþ ïðåïàðàòîâ ðîçóâàñòàòèíà çà 2010–2015 ãã., è ïîäãîòîâêà ðåêîìåíäàöèé ïî ïëàíèðîâàíèþ, äèçàéíó è îöåíêå ðåçóëüòàòîâ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè.

7
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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    êîýôôèöèåíò âíóòðèèíäèâèäóàëüíîé âàðèàáåëüíîñòè (CVintra)îäíîãî èç äâóõ îñíîâíûõ ïàðàìåòðîâ áèîýêâèâàëåíòíîñòè (ìàêñèìàëüíàÿ êîíöåíòðàöèÿ â êðîâè (Cmax)è ïëîùàäü ïîä êðèâîé «êîíöåíòðàöèÿ–âðåìÿ »(AUC)) ñîñòàâëÿåò³30 %. Äðóãèìè ñëîâàìè, ýòî ïðåïàðàòû, ñêîðîñòü è ñòåïåíü âñàñûâàíèÿ êîòîðûõ äåìîíñòðèðóþò âûñîêóþ âàðèàáåëüíîñòü ó îäíîãî è òîãî æå ñóáúåêòà ïðè ïðèåìå ËÏ â îäèíàêîâîé äîçèðîâêå
    Exact
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    . Öåëü ðàáîòû — ðåòðîñïåêòèâíûé àíàëèç ðåçóëüòàòîâ ïðîâåäåííûõ ýêñïåðòèç îò÷åòîâ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè, ïîñòóïàâøèõ íà ðåãèñòðàöèþ ïðåïàðàòîâ ðîçóâàñòàòèíà çà 2010–2015 ãã., è ïîäãîòîâêà ðåêîìåíäàöèé ïî ïëàíèðîâàíèþ, äèçàéíó è îöåíêå ðåçóëüòàòîâ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè.

8
Investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1). European Medicines Agency. Available from: https:// goo.gl/qmaH1d.
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    –t(AUCâ èíòåðâàëå âðåìåíè îò 0 äî ìîìåíòàtîòáîðà ïîñëåäíåé ïðîáû êðîâè) èç èñõîäíûõ äàííûõ î êîíöåíòðàöèÿõ ðîçóâàñòàòèíà èññëåäóåìûõ ïðåïàðàòîâ â ñðàâíåíèè ñ ðåôåðåíòíûì ïðåïàðàòîì.AUC0–tðàññ÷èòûâàëè ìåòîäîì òðàïåöèé â ïðîãðàììå Microsoft Office Excel 2007. Ôàðìàêîêèíåòè÷åñêèå ïàðàìåòðû áûëè ëîãàðèôìè÷åñêè ïðåîáðàçîâàíû è ïîäâåðãíóòû äèñïåðñèîííîìó àíàëèçó (Analysis of variance (ANOVA))
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    ñ ïîìîùüþ ïðîãðàììû Statistica 10.  äèñïåðñèîííûé àíàëèç áûëè âêëþ÷åíû ñëåäóþùèå ôàêòîðû, âíîñÿùèå âêëàä â íàáëþäàåìóþ âàðèàöèþ äàííûõ: ðàçëè÷èÿ ìåæäó ïðåïàðàòàìè, ðàçëè÷èÿ ìåæäó èñïûòóåìûìè (ìåæèíäèâèäóàëüíûå ðàçëè÷èÿ), ïîñëåäîâàòåëüíîñòü ïðèåìà ïðåïàðàòîâ, ïåðèîäû èññëåäîâàíèÿ.

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     ðàìêàõ ìîäåëüíûõ èññëåäîâàíèé ïðîâåäåí ðàñ÷åò îñíîâíûõ ôàðìàêîêèíåòè÷åñêèõ ïàðàìåòðîâCmax èAUC0–t. Çíà÷åíèåAUC0–tðàññ÷èòàíî ìåòîäîì òðàïåöèé. Ôàðìàêîêèíåòè÷åñêèå ïàðàìåòðû áûëè ëîãàðèôìè÷åñêè ïðåîáðàçîâàíû è ïîäâåðãíóòû äèñïåðñèîííîìó àíàëèçó ANOVA
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    .  ANOVA áûëè âêëþ÷åíû ñëåäóþùèå ôàêòîðû, âíîñÿùèå âêëàä â íàáëþäàåìóþ âàðèàáåëüíîñòü äàííûõ: ðàçëè÷èÿ ìåæäó ïðåïàðàòàìè, ðàçëè÷èÿ ìåæäó ñóáúåêòàìè (ìåæèíäèâèäóàëüíûå ðàçëè÷èÿ), ïîñëåäîâàòåëüíîñòü ïðèåìà ïðåïàðàòîâ, ïåðèîäû èññëåäîâàíèÿ.

9
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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    ́220ÊðåñòîðÐîññèÿ34 142 ́240ÊðåñòîðÐîññèÿ28 152 ́240ÊðåñòîðÐîññèÿ28 162 ́220ÊðåñòîðÐîññèÿ28 172 ́220ÊðåñòîðÐîññèÿ36 íîé êîíöåíòðàöèè â èññëåäîâàíèÿõ èçó÷àåìûõ ïðåïàðàòîâ è ðåôåðåíòíîãî ïðåïàðàòà ñîñòàâèëî 3,80±0,62 ÷ è 3,77±0,59 ÷ ñîîòâåòñòâåííî (òàáë. 2). Ñîãëàñíî ñâåäåíèÿì, ñîäåðæàùèìñÿ â èíñòðóêöèè ðåôåðåíòíîãî ïðåïàðàòà, âðåìÿ äîñòèæåíèÿ ìàêñèìàëüíîé êîíöåíòðàöèè ñîñòàâëÿåò 5 ÷àñîâ
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    . Òàêèì îáðàçîì, ïðè âûáîðå òî÷åê çàáîðà îáðàçöîâ êðîâè äëÿ ôàðìàêîêèíåòè÷åñêîãî àíàëèçà ñëåäóåò ó÷èòûâàòü îáùóþ äëèòåëüíîñòü 72 ÷, è áîëåå ÷àñòûé îòáîð îáðàçöîâ êðîâè â äèàïàçîíå âðåìåíè äîñòèæåíèÿ Cmax(2,5–5,5 ÷).

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    Òàêèì îáðàçîì, ïðè âûáîðå òî÷åê çàáîðà îáðàçöîâ êðîâè äëÿ ôàðìàêîêèíåòè÷åñêîãî àíàëèçà ñëåäóåò ó÷èòûâàòü îáùóþ äëèòåëüíîñòü 72 ÷, è áîëåå ÷àñòûé îòáîð îáðàçöîâ êðîâè â äèàïàçîíå âðåìåíè äîñòèæåíèÿ Cmax(2,5–5,5 ÷). Ïåðèîä îòìûâêè â áîëüøèíñòâå èññëåäîâàíèé ñîñòàâëÿë 14 äíåé è ñîîòâåòñòâîâàë ïðàâèëó «íå ìåíåå ïÿòè ïåðèîäîâ ïîëóâûâåäåíèÿ», ó÷èòûâàÿ ïåðèîä ïîëóâûâåäåíèÿ 19 ÷
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    . Íàèáîëåå ÷àñòî äëÿ îïðåäåëåíèÿ ðîçóâàñòàòèíà â ïðîáàõ êðîâè èñïîëüçîâàëñÿ àíàëèòè÷åñêèé ìåòîä — âûñîêîýôôåêòèâíàÿ æèäêîñòíàÿ õðîìàòîãðàôèÿ (ÂÝÆÕ) ñ ìàññ-ñïåêòðîìåòðè÷åñêîé äåòåêöèåé èëè òàíäåìíîé ìàññ-ñïåêòðîìåòðè÷åñêîé äåòåêöèåé.

10
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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    ñ óëüòðàôèîëåòîâîé äåòåêöèåé Ðèñ. 1.Êîëè÷åñòâî çäîðîâûõ äîáðîâîëüöåâ ïî äàííûì 17 èññëåäîâàíèé áèîýêâèâàëåíòíîñòè Àíàëèç äàííûõ ëèòåðàòóðû Ñ öåëüþ ñðàâíèòåëüíîé îöåíêè èñïîëüçóåìûõ äèçàéíîâ è ïîëó÷åííûõ äàííûõ áûëè ïðîàíàëèçèðîâàíû ðåçóëüòàòû îïóáëèêîâàííûõ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè ðîçóâàñòàòèíà.  ðåçóëüòàòå ïðîâåäåííîãî ïîèñêà áûëî âûÿâëåíî ñåìü äîñòóïíûõ èñòî÷íèêîâ (òàáë. 5)
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    .  ñëó÷àå îòñóòñòâèÿ â èñòî÷íèêàõ äàííûõ ïî ÑVintra, çíà÷åíèå êîýôôèöèåíòà ðàññ÷èòûâàëè, èñõîäÿ èç èçâåñòíûõ çíà÷åíèé ïîëó÷åííûõ 90 % äîâåðèòåëüíûõ èíòåðâàëîâ è äàííûõ î êîëè÷åñòâå äîáðîâîëüöåâ, âêëþ÷åííûõ â ñòàòèñòè÷åñêèé àíàëèç ïî ñëåäóþùèì ôîðìóëàì.

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    Òàáëèöà 5 ÀÍÀËÈÇ ÄÀÍÍÛÕ ËÈÒÅÐÀÒÓÐÛ ÈÑÑËÅÄÎÂÀÍÈÉ ÁÈÎÝÊÂÈÂÀËÅÍÒÍÎÑÒÈ ÐÎÇÓÂÀÑÒÀÒÈÍÀ Èñòî÷íèêÄèçàéí*nÄîçèðîâ-êà, ìãCmax,90 % ÄÈAUC0–t,90 % ÄÈCVintraCmax,%CVintraAUC 0–t, % Îïðåäåëåíèå ðîçóâàñòàòèíà â ïëàçìå êðîâè ìåòîäîì ÂÝÆÕ-ÌÑ/ÌÑ è åãî èñïîëüçîâàíèå â èññëåäîâàíèè áèîýêâèâàëåíòíîñòè
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    2 ́2142091,45–114,24 84,88–122,2514***23,3*** Äâóõýòàïíîå ïåðåêðåñòíîå èññëåäîâàíèå áèîýêâèâàëåíòíîñòè òàáëåòîê ðîçóâàñòàòèíà 5 ìã ó çäîðîâûõ âçðîñëûõ èíäèéñêèõ äîáðîâîëüöåâ ìóæñêîãî ïîëà íàòîùàê [11] 2 ́240593,40–116,4 93,61–112,1028,5**23,2** Âàëèäèðîâàííûé ìåòîä ÂÝÆÕ-ÌÑ/ÌÑ äëÿ îïðåäåëåíèÿ ðîçóâàñòàòèíà â ïëàçìå êðîâè: ïðèìåíåíèå â ðàìêàõ èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ó êèòàéñêèõ äîáðîâîëüö

11
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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    ÷íèêÄèçàéí*nÄîçèðîâ-êà, ìãCmax,90 % ÄÈAUC0–t,90 % ÄÈCVintraCmax,%CVintraAUC 0–t, % Îïðåäåëåíèå ðîçóâàñòàòèíà â ïëàçìå êðîâè ìåòîäîì ÂÝÆÕ-ÌÑ/ÌÑ è åãî èñïîëüçîâàíèå â èññëåäîâàíèè áèîýêâèâàëåíòíîñòè [10] 2 ́2142091,45–114,24 84,88–122,2514***23,3*** Äâóõýòàïíîå ïåðåêðåñòíîå èññëåäîâàíèå áèîýêâèâàëåíòíîñòè òàáëåòîê ðîçóâàñòàòèíà 5 ìã ó çäîðîâûõ âçðîñëûõ èíäèéñêèõ äîáðîâîëüöåâ ìóæñêîãî ïîëà íàòîùàê
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    2 ́240593,40–116,4 93,61–112,1028,5**23,2** Âàëèäèðîâàííûé ìåòîä ÂÝÆÕ-ÌÑ/ÌÑ äëÿ îïðåäåëåíèÿ ðîçóâàñòàòèíà â ïëàçìå êðîâè: ïðèìåíåíèå â ðàìêàõ èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ó êèòàéñêèõ äîáðîâîëüöåâ [12] 2 ́2201099,4–111,1 96,2–110,810,2***13*** Ïóáëè÷íûé îò÷åò ãîëëàíäñêîãî ðåãóëÿòîðà ñ îöåíêîé èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ðîçóâàñòàòèíà ôèðìû «Òîððåíò» [13] 2 ́248200,87–1,010,89–1,0021***1

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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    ,45–114,24 84,88–122,2514***23,3*** Äâóõýòàïíîå ïåðåêðåñòíîå èññëåäîâàíèå áèîýêâèâàëåíòíîñòè òàáëåòîê ðîçóâàñòàòèíà 5 ìã ó çäîðîâûõ âçðîñëûõ èíäèéñêèõ äîáðîâîëüöåâ ìóæñêîãî ïîëà íàòîùàê [11] 2 ́240593,40–116,4 93,61–112,1028,5**23,2** Âàëèäèðîâàííûé ìåòîä ÂÝÆÕ-ÌÑ/ÌÑ äëÿ îïðåäåëåíèÿ ðîçóâàñòàòèíà â ïëàçìå êðîâè: ïðèìåíåíèå â ðàìêàõ èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ó êèòàéñêèõ äîáðîâîëüöåâ
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    2 ́2201099,4–111,1 96,2–110,810,2***13*** Ïóáëè÷íûé îò÷åò ãîëëàíäñêîãî ðåãóëÿòîðà ñ îöåíêîé èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ðîçóâàñòàòèíà ôèðìû «Òîððåíò» [13] 2 ́248200,87–1,010,89–1,0021***16,4*** Ïóáëè÷íûé îò÷åò ãîëëàíäñêîãî ðåãóëÿòîðà ñ îöåíêîé èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ðîçóâàñòàòèíà ôèðìû «Òîððåíò» [13] 2 ́248400,87–1,040,91–1,0225,3***16*** Èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïà

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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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    ìóæñêîãî ïîëà íàòîùàê [11] 2 ́240593,40–116,4 93,61–112,1028,5**23,2** Âàëèäèðîâàííûé ìåòîä ÂÝÆÕ-ÌÑ/ÌÑ äëÿ îïðåäåëåíèÿ ðîçóâàñòàòèíà â ïëàçìå êðîâè: ïðèìåíåíèå â ðàìêàõ èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ó êèòàéñêèõ äîáðîâîëüöåâ [12] 2 ́2201099,4–111,1 96,2–110,810,2***13*** Ïóáëè÷íûé îò÷åò ãîëëàíäñêîãî ðåãóëÿòîðà ñ îöåíêîé èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ðîçóâàñòàòèíà ôèðìû «Òîððåíò»
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    2 ́248200,87–1,010,89–1,0021***16,4*** Ïóáëè÷íûé îò÷åò ãîëëàíäñêîãî ðåãóëÿòîðà ñ îöåíêîé èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ðîçóâàñòàòèíà ôèðìû «Òîððåíò» [13] 2 ́248400,87–1,040,91–1,0225,3***16*** Èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà â òàáëåòêàõ 40 ìã ó çäîðîâûõ êîëóìáèéñêèõ äîáðîâîëüöåâ [14] 2 ́2304089,5–121.4 82,0–114.635,7***36,03*** Äâóõýòàïíîå ïåðåêðåñòíîå èññëåäîâà

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    : ïðèìåíåíèå â ðàìêàõ èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ó êèòàéñêèõ äîáðîâîëüöåâ [12] 2 ́2201099,4–111,1 96,2–110,810,2***13*** Ïóáëè÷íûé îò÷åò ãîëëàíäñêîãî ðåãóëÿòîðà ñ îöåíêîé èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ðîçóâàñòàòèíà ôèðìû «Òîððåíò» [13] 2 ́248200,87–1,010,89–1,0021***16,4*** Ïóáëè÷íûé îò÷åò ãîëëàíäñêîãî ðåãóëÿòîðà ñ îöåíêîé èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ðîçóâàñòàòèíà ôèðìû «Òîððåíò»
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    [13]
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    2 ́248400,87–1,040,91–1,0225,3***16*** Èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà â òàáëåòêàõ 40 ìã ó çäîðîâûõ êîëóìáèéñêèõ äîáðîâîëüöåâ [14] 2 ́2304089,5–121.4 82,0–114.635,7***36,03*** Äâóõýòàïíîå ïåðåêðåñòíîå èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà ó çäîðîâûõ äîáðîâîëüöåâ íàòîùàê ïðè îäíîêðàòíîì ïðèåìå [15] 2 ́2394091,91–106,06 97,38–108,66 18,85

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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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    ñ îöåíêîé èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ðîçóâàñòàòèíà ôèðìû «Òîððåíò» [13] 2 ́248200,87–1,010,89–1,0021***16,4*** Ïóáëè÷íûé îò÷åò ãîëëàíäñêîãî ðåãóëÿòîðà ñ îöåíêîé èññëåäîâàíèÿ áèîýêâèâàëåíòíîñòè ðîçóâàñòàòèíà ôèðìû «Òîððåíò» [13] 2 ́248400,87–1,040,91–1,0225,3***16*** Èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà â òàáëåòêàõ 40 ìã ó çäîðîâûõ êîëóìáèéñêèõ äîáðîâîëüöåâ
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    2 ́2304089,5–121.4 82,0–114.635,7***36,03*** Äâóõýòàïíîå ïåðåêðåñòíîå èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà ó çäîðîâûõ äîáðîâîëüöåâ íàòîùàê ïðè îäíîêðàòíîì ïðèåìå [15] 2 ́2394091,91–106,06 97,38–108,66 18,85**14,38** Èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà ó çäîðîâûõ èíäîíåçèéñêèõ äîáðîâîëüöåâ [16] 2 ́2244089,37–110,41 87,56–103,53 21,24**1

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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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    ðîçóâàñòàòèíà ôèðìû «Òîððåíò» [13] 2 ́248400,87–1,040,91–1,0225,3***16*** Èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà â òàáëåòêàõ 40 ìã ó çäîðîâûõ êîëóìáèéñêèõ äîáðîâîëüöåâ [14] 2 ́2304089,5–121.4 82,0–114.635,7***36,03*** Äâóõýòàïíîå ïåðåêðåñòíîå èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà ó çäîðîâûõ äîáðîâîëüöåâ íàòîùàê ïðè îäíîêðàòíîì ïðèåìå
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    [15]
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    2 ́2394091,91–106,06 97,38–108,66 18,85**14,38** Èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà ó çäîðîâûõ èíäîíåçèéñêèõ äîáðîâîëüöåâ [16] 2 ́2244089,37–110,41 87,56–103,53 21,24**16,82** Ïðèìå÷àíèå: n— êîëè÷åñòâî äîáðîâîëüöåâ;AUC0–t— ïëîùàäü ïîä êðèâîé «êîíöåíòðàöèÿ–âðåìÿ »â èíòåðâàëå âðåìåíè îò 0 äî ìîìåíòàtîòáîðà ïîñëåäíåé ïðîáû êðîâè;Cmax— ìàêñèìàëüíàÿ êîíöåíòðàöèÿ â êð

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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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    40 ìã ó çäîðîâûõ êîëóìáèéñêèõ äîáðîâîëüöåâ [14] 2 ́2304089,5–121.4 82,0–114.635,7***36,03*** Äâóõýòàïíîå ïåðåêðåñòíîå èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà ó çäîðîâûõ äîáðîâîëüöåâ íàòîùàê ïðè îäíîêðàòíîì ïðèåìå [15] 2 ́2394091,91–106,06 97,38–108,66 18,85**14,38** Èññëåäîâàíèå áèîýêâèâàëåíòíîñòè äâóõ ïðåïàðàòîâ ðîçóâàñòàòèíà ó çäîðîâûõ èíäîíåçèéñêèõ äîáðîâîëüöåâ
    Exact
    [16]
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    2 ́2244089,37–110,41 87,56–103,53 21,24**16,82** Ïðèìå÷àíèå: n— êîëè÷åñòâî äîáðîâîëüöåâ;AUC0–t— ïëîùàäü ïîä êðèâîé «êîíöåíòðàöèÿ–âðåìÿ »â èíòåðâàëå âðåìåíè îò 0 äî ìîìåíòàtîòáîðà ïîñëåäíåé ïðîáû êðîâè;Cmax— ìàêñèìàëüíàÿ êîíöåíòðàöèÿ â êðîâè;CVintra— êîýôôèöèåíò âíóòðèèíäèâèäóàëüíîé âàðèàáåëüíîñòè;*—2 ́2 — ðàíäîìèçèðîâàííîå äâóõïåðèîäíîå ïåðåêðåñòíîå â äâóõ ïîñëåäîâàòåëüíîñòÿõ èññëåäîâàíèå ñ ï

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    îøèáêà;AUC0–t— ïëîùàäü ïîä êðèâîé «êîíöåíòðàöèÿ–âðåìÿ »â èíòåðâàëå âðåìåíè îò 0 î ìîìåíòàtîòáîðà ïîñëåäíåé ïðîáû êðîâè;Cmax— ìàêñèìàëüíàÿ êîíöåíòðàöèÿ â êðîâè;CVintra— êîýôôèöèåíò âíóòðèèíäèâèäóàëüíîé âàðèàáåëüíîñòè Òàáëèöà 7 ×ÈÑËÎ ÑÓÁÚÅÊÒÎÂ, ÒÐÅÁÓÅÌÛÕ ÄËß ÄÅÌÎÍÑÒÐÀÖÈÈ ÁÈÎÝÊÂÈÂÀËÅÍÒÍÎÑÒÈ ÏÐÈ ÌÎÙÍÎÑÒÈ ÈÑÑËÅÄÎÂÀÍÈß 80 %  ÇÀÂÈÑÈÌÎÑÒÈ ÎÒ ÇÍÀ×ÅÍÈß ÊÎÝÔÔÈÖÈÅÍÒÀ ÂÍÓÒÐÈÈÍÄÈÂÈÄÓÀËÜÍÎÉ ÂÀÐÈÀÁÅËÜÍÎÑÒÈ
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    Êîýôôèöèåíò âíóòðèèíäèâèäóàëüíîé âàðèàáåëüíîñòè (CVintra), % Ðàçìåð âûáîðêè äëÿ äâóõïåðèîäíîãî ïåðåêðåñòíîãî èññëåäîâàíèÿ. GMR = 1 Ðàçìåð âûáîðêè äëÿ ÷åòûðåõïåðèîäíîãî èññëåäîâàíèÿ ñ äâóìÿ ïåðåêðåñòàìè (ïîëíûé ïîâòîðíûé äèçàéí).