The 10 references with contexts in paper I. Snegireva I., K. Zatolochina E., M. Darmostukova A., R. Alyautdin N., B. Romanov K., И. Снегирева И., К. Затолочина Э., М. Дармостукова А., Р. Аляутдин Н., Б. Романов К. (2018) “Современные подходы к взаимозаменяемости вакцин // Modern approaches to vaccines interchangeability” / spz:neicon:vedomostincesmp:y:2016:i:4:p:3-8

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Federal Law of Russian Federation of 22.12.2014 ¹ 429-FZ, «On Amendments to the Federal Law «On Circulation of Medicines» (in Russian).
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    Ñîãëàñíî ðîññèéñêîìó çàêîíîäàòåëüñòâó, âçàèìîçàìåíÿåìûì ëåêàðñòâåííûì ïðåïàðàòîì (ËÏ) ÿâëÿåòñÿ ËÏ ñ äîêàçàííîé òåðàïåâòè÷åñêîé ýêâèâàëåíòíîñòüþ èëè áèîýêâèâàëåíòíîñòüþ â îòíîøåíèè ðåôåðåíòíîãî ïðåïàðàòà, èìåþùèé ýêâèâàëåíòíûé åìó êà÷åñòâåííûé è êîëè÷åñòâåííûé ñîñòàâ äåéñòâóþùèõ âåùåñòâ, âñïîìîãàòåëüíûõ âåùåñòâ, ëåêàðñòâåííóþ ôîðìó è ñïîñîá ââåäåíèÿ
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    [1]
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    .  äàííîì îïðåäåëåíèè íå ïðîâîäèòñÿ ÷åòêîé ãðàíè ìåæäó êðèòåðèÿìè âçàèìîçàìåíÿåìîñòè äëÿ õèìè÷åñêèõ è èììóíîáèîëîãè÷åñêèõ ïðåïàðàòîâ, êîòîðûå ïðèíöèïèàëüíî ðàçëè÷àþòñÿ ïî ïðîèñõîæäåíèþ, ìåõàíèçìó äåéñòâèÿ è ñïîñîáíîñòè âûçûâàòü èììóííûå ðåàêöèè [2].

2
Borzova M. Interchangeability of biological medicines: fantasy or reality? Remedium 2014; (9): 6–13 (in Russian).
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     äàííîì îïðåäåëåíèè íå ïðîâîäèòñÿ ÷åòêîé ãðàíè ìåæäó êðèòåðèÿìè âçàèìîçàìåíÿåìîñòè äëÿ õèìè÷åñêèõ è èììóíîáèîëîãè÷åñêèõ ïðåïàðàòîâ, êîòîðûå ïðèíöèïèàëüíî ðàçëè÷àþòñÿ ïî ïðîèñõîæäåíèþ, ìåõàíèçìó äåéñòâèÿ è ñïîñîáíîñòè âûçûâàòü èììóííûå ðåàêöèè
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    . Âçàèìîçàìåíÿåìîñòü âîñïðîèçâåäåííûõ ËÏ (ïîëó÷åííûõ ìåòîäîì õèìè÷åñêîãî ñèíòåçà) â öåëîì áàçèðóåòñÿ íà áèîýêâèâàëåíòíîñòè ñðàâíèâàåìûõ ËÏ, à ïðè îöåíêå ñîïîñòàâèìîñòè áèîëîãè÷åñêèõ ïðåïàðàòîâ íåâîçìîæíî îïèðàòüñÿ èñêëþ÷èòåëüíî íà êðèòåðèé áèîýêâèâàëåíòíîñòè.

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Mironov AN, ed. Guidance on the examination of medicines. V. 4. Moscow: Poligraf-Plus; 2014 (in Russian).
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    Îãðàíè÷åííûå íà ñåãîäíÿøíèé äåíü âîçìîæíîñòè ïðîãíîçèðîâàíèÿ êëèíè÷åñêèõ ñâîéñòâ áèîëîãè÷åñêèõ ìîëåêóë, îòëè÷àþùèõñÿ ñëîæíîñòüþ ñòðîåíèÿ, íà îñíîâàíèè çíàíèé èõ ôèçèêî-õèìè÷åñêèõ õàðàêòåðèñòèê îáóñëàâëèâàþò íåâîçìîæíîñòü ïðèìåíåíèÿ êîíöåïöèè áèîýêâèâàëåíòíîñòè ïðè îöåíêå âçàèìîçàìåíÿåìîñòè áèîëîãè÷åñêèõ ËÏ
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    . Ïðè ýòîì îïðåäåëåíèå «âçàèìîçàìåíÿåìîñòü »íå ìîæåò ðàñïðîñòðàíÿòüñÿ íà èììóíîáèîëîãè÷åñêèå ëåêàðñòâåííûå ïðåïàðàòû (ÈËÏ), êàæäûé èç êîòîðûõ, âíå çàâèñèìîñòè îò îòñóòñòâèÿ ðàçëè÷èé â ìåõàíèçìå äåéñòâèÿ, òåõíîëîãèè èçãîòîâëåíèÿ ïðîèçâîäñòâåííîãî øòàììà, ñïîñîáå ââåäåíèÿ è äðóãèõ õàðàêòåðèñòèêàõ ñ ïðåïàðàòîì àíàëîãè÷íîãî íàçíà÷åíèÿ, âûïóñêàåìûì äðóãèì ïðîèçâîäèòåëåì, ÿâëÿåòñÿ îðèãèíàëüíûì ËÏ.

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Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies. 3rd ed. New York: CRC Press; 2008.
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    Îãðàíè÷åííûå íà ñåãîäíÿøíèé äåíü âîçìîæíîñòè ïðîãíîçèðîâàíèÿ êëèíè÷åñêèõ ñâîéñòâ áèîëîãè÷åñêèõ ìîëåêóë, îòëè÷àþùèõñÿ ñëîæíîñòüþ ñòðîåíèÿ, íà îñíîâàíèè çíàíèé èõ ôèçèêî-õèìè÷åñêèõ õàðàêòåðèñòèê îáóñëàâëèâàþò íåâîçìîæíîñòü ïðèìåíåíèÿ êîíöåïöèè áèîýêâèâàëåíòíîñòè ïðè îöåíêå âçàèìîçàìåíÿåìîñòè áèîëîãè÷åñêèõ ËÏ
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    . Ïðè ýòîì îïðåäåëåíèå «âçàèìîçàìåíÿåìîñòü »íå ìîæåò ðàñïðîñòðàíÿòüñÿ íà èììóíîáèîëîãè÷åñêèå ëåêàðñòâåííûå ïðåïàðàòû (ÈËÏ), êàæäûé èç êîòîðûõ, âíå çàâèñèìîñòè îò îòñóòñòâèÿ ðàçëè÷èé â ìåõàíèçìå äåéñòâèÿ, òåõíîëîãèè èçãîòîâëåíèÿ ïðîèçâîäñòâåííîãî øòàììà, ñïîñîáå ââåäåíèÿ è äðóãèõ õàðàêòåðèñòèêàõ ñ ïðåïàðàòîì àíàëîãè÷íîãî íàçíà÷åíèÿ, âûïóñêàåìûì äðóãèì ïðîèçâîäèòåëåì, ÿâëÿåòñÿ îðèãèíàëüíûì ËÏ.

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Ozeretskovsky NA, Zatolochina KE, Snegireva II. Proposals for the prevention of adverse events when using immunobiological drugs in the Russian Federation. Bezopasnost i risk farmakoterapii 2015; (2): 25–9 (in Russian).
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    Âûáîð ïðåïàðàòà ïðè åãî íàçíà÷åíèè îïðåäåëÿåò âðà÷, ðóêîâîäñòâóÿñü Íàöèîíàëüíûì êàëåíäàðåì ïðîôèëàêòè÷åñêèõ ïðèâèâîê, êàëåíäàðåì ïðîôèëàêòè÷åñêèõ ïðèâèâîê ïî ýïèäåìè÷åñêèì ïîêàçàíèÿì, ñàíèòàðíî-ýïèäåìèîëîãè÷åñêèìè ïðàâèëàìè, â îòíîøåíèè ñîîòâåòñòâóþùåé èíôåêöèîííîé áîëåçíè, èíñòðóêöèÿìè ïî ìåäèöèíñêîìó ïðèìåíåíèþ ïðåïàðàòîâ
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    . Íàëè÷èå íà ôàðìàöåâòè÷åñêîì ðûíêå áîëüøîãî ÷èñëà ðàçíûõ òîðãîâûõ íàèìåíîâàíèé âàêöèí, ïðåäíàçíà÷åííûõ äëÿ ïðîôèëàêòèêè îäíèõ è òåõ æå èíôåêöèîííûõ áîëåçíåé [6], íåîáõîäèìîñòü ìíîãîêðàòíîãî ââåäåíèÿ ïðåïàðàòà â òå÷åíèå êóðñà âàêöèíàöèè, à òàêæå ðàçëè÷íûå îáñòîÿòåëüñòâà, ñâÿçàííûå ñ îòñóòñòâèåì âàêöèí êîíêðåòíîãî ïðîèçâîäèòåëÿ, ìèãðàöèåé âàêöèíèðóåìîãî íàñåëåíèÿ, çàìåíîé ïîñòàâùèêîâ ïðåïàðàòîâ, ïð

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Borisevich IV, Vorobieva MS, Gayderova LA, Gorbunov MA, Davydov DS, Ignatiev GM et al. Medical immunobiological preparations. Directory. V. 1. Vaccines. Moscow: Gella-print; 2010 (in Russian).
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    ÷åñêèõ ïðèâèâîê, êàëåíäàðåì ïðîôèëàêòè÷åñêèõ ïðèâèâîê ïî ýïèäåìè÷åñêèì ïîêàçàíèÿì, ñàíèòàðíî-ýïèäåìèîëîãè÷åñêèìè ïðàâèëàìè, â îòíîøåíèè ñîîòâåòñòâóþùåé èíôåêöèîííîé áîëåçíè, èíñòðóêöèÿìè ïî ìåäèöèíñêîìó ïðèìåíåíèþ ïðåïàðàòîâ [5]. Íàëè÷èå íà ôàðìàöåâòè÷åñêîì ðûíêå áîëüøîãî ÷èñëà ðàçíûõ òîðãîâûõ íàèìåíîâàíèé âàêöèí, ïðåäíàçíà÷åííûõ äëÿ ïðîôèëàêòèêè îäíèõ è òåõ æå èíôåêöèîííûõ áîëåçíåé
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    , íåîáõîäèìîñòü ìíîãîêðàòíîãî ââåäåíèÿ ïðåïàðàòà â òå÷åíèå êóðñà âàêöèíàöèè, à òàêæå ðàçëè÷íûå îáñòîÿòåëüñòâà, ñâÿçàííûå ñ îòñóòñòâèåì âàêöèí êîíêðåòíîãî ïðîèçâîäèòåëÿ, ìèãðàöèåé âàêöèíèðóåìîãî íàñåëåíèÿ, çàìåíîé ïîñòàâùèêîâ ïðåïàðàòîâ, ïðèíÿòèåì àäìèíèñòðàòèâíûõ ðåøåíèé îá îòçûâå èëè ïðèîñòàíîâëåíèè èñïîëüçîâàíèÿ ïðåïàðàòîâ, äèêòóþò íåîáõîäèìîñòü ðåøåíèÿ âîïðîñà î âçàèìîçàìåíÿåìîñòè îäíîíà

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Snegireva II, Zatolochina KE, Darmostukova MA, Khotova TYu, Alyautdin RN, Ozeretskovsky NA. et al. Vaccine Interchangeability. Uspehi sovremennogo estestvoznaniya 2015; (8): 43–7 (in Russian).
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    â òå÷åíèå êóðñà âàêöèíàöèè, à òàêæå ðàçëè÷íûå îáñòîÿòåëüñòâà, ñâÿçàííûå ñ îòñóòñòâèåì âàêöèí êîíêðåòíîãî ïðîèçâîäèòåëÿ, ìèãðàöèåé âàêöèíèðóåìîãî íàñåëåíèÿ, çàìåíîé ïîñòàâùèêîâ ïðåïàðàòîâ, ïðèíÿòèåì àäìèíèñòðàòèâíûõ ðåøåíèé îá îòçûâå èëè ïðèîñòàíîâëåíèè èñïîëüçîâàíèÿ ïðåïàðàòîâ, äèêòóþò íåîáõîäèìîñòü ðåøåíèÿ âîïðîñà î âçàèìîçàìåíÿåìîñòè îäíîíàïðàâëåííûõ âàêöèí ðàçíûõ ïðîèçâîäèòåëåé
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    .  îôèöèàëüíûõ ðóêîâîäÿùèõ äîêóìåíòàõ ïî èììóíîïðîôèëàêòèêå íåêîòîðûõ çàðóáåæíûõ ñòðàí òåðìèíîì «âçàèìîçàìåíÿåìîñòü »(interchangeability) îáîçíà÷àþò ïðàêòèêó ïåðåõîäà îò âàêöèíû îäíîãî ïðîèçâîäèòåëÿ ê ïðåïàðàòó àíàëîãè÷íîãî íàçíà÷åíèÿ äðóãîãî ïðîèçâîäèòåëÿ.

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Feldman S. Interchangeability of vaccines. Pediatric Infectious Disease Journal 2001; 20(11): 23–9.
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    â òå÷åíèå êóðñà âàêöèíàöèè, à òàêæå ðàçëè÷íûå îáñòîÿòåëüñòâà, ñâÿçàííûå ñ îòñóòñòâèåì âàêöèí êîíêðåòíîãî ïðîèçâîäèòåëÿ, ìèãðàöèåé âàêöèíèðóåìîãî íàñåëåíèÿ, çàìåíîé ïîñòàâùèêîâ ïðåïàðàòîâ, ïðèíÿòèåì àäìèíèñòðàòèâíûõ ðåøåíèé îá îòçûâå èëè ïðèîñòàíîâëåíèè èñïîëüçîâàíèÿ ïðåïàðàòîâ, äèêòóþò íåîáõîäèìîñòü ðåøåíèÿ âîïðîñà î âçàèìîçàìåíÿåìîñòè îäíîíàïðàâëåííûõ âàêöèí ðàçíûõ ïðîèçâîäèòåëåé
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    .  îôèöèàëüíûõ ðóêîâîäÿùèõ äîêóìåíòàõ ïî èììóíîïðîôèëàêòèêå íåêîòîðûõ çàðóáåæíûõ ñòðàí òåðìèíîì «âçàèìîçàìåíÿåìîñòü »(interchangeability) îáîçíà÷àþò ïðàêòèêó ïåðåõîäà îò âàêöèíû îäíîãî ïðîèçâîäèòåëÿ ê ïðåïàðàòó àíàëîãè÷íîãî íàçíà÷åíèÿ äðóãîãî ïðîèçâîäèòåëÿ.

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Public Health Agency of Canada. Canadian Immunization Guide. PrinciplesofVaccineInterchangeability.Availablefrom: http://www.phac-aspc.gc.ca/publicat/cig-gci/p01-06-eng.php. 84(40): 405–20. 11. CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011; 60(RR02): 1–60. Available from: http://www.cdc.gov/ mmwr/preview/mmwrhtml/rr6002a1.htm. 12. CDC. A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: Immunization of Adults. MMWR 2006; 55(RR16): 1–25. Available from: http://www.cdc.gov/mmwr/preview/mmwrhtml/ rr5516a1.htm. 13. Hamborsky J, Kroger A, Wolf
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    Òàê, ñîãëàñíî îñíîâíûì ïðèíöèïàì âçàèìîçàìåíÿåìîñòè âàêöèí â Êàíàäå (äèðåêòèâà Health Canada), âçàèìîçàìåíÿåìûå âàêöèíû äîëæíû èìåòü îäèíàêîâûå ïîêàçàíèÿ ê ïðèìåíåíèþ ñ ó÷åòîì âîçðàñòíûõ îãðàíè÷åíèé; ïåðå÷íè ìåäèöèíñêèõ ïðîòèâîïîêàçàíèé; ñõåìû ïðèìåíåíèÿ; ñîñòàâû àíòèãåíîâ; ïîêàçàòåëè áåçîïàñíîñòè, ðåàêòîãåííîñòè, èììóíîãåííîñòè è ýôôåêòèâíîñòè
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    . Ê âûøåóêàçàííûì ïðèíöèïàì âçàèìîçàìåíÿåìîñòè âàêöèí, ïî ìíåíèþ àâòîðîâ, íåîáõîäèìî äîáàâèòü ðàâíóþ èëè áîëüøóþ ïðîäîëæèòåëüíîñòü è âûðàæåííîñòü ïðîôèëàêòè÷åñêîé ýôôåêòèâíîñòè (æèâûå è èíàêòèâèðîâàííûå âàêöèíû, àíàòîêñèíû).

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Hepatitis B Vaccine. Position Paper WHO. Wkly Epidemiol Rec. 2009; 23. Bush LM, Moonsammy GI, Bosciaj A. Evaluation of initiating a hepatitis B vaccination schedule with one vaccine and completing it with another. Vaccine 1991; (9): 807–9.
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    Áîëåå ÷åì òðèäöàòèëåòíèé ìèðîâîé îïûò ïðèìåíåíèÿ ðåêîìáèíàíòíûõ âàêöèí ïðîòèâ ãåïàòèòà B ïîêàçàë âîçìîæíîñòü èõ âçàèìîçàìåíÿåìîñòè (ðàâíîöåííîé çàìåíû).  ñîîòâåòñòâèè ñ ïîçèöèåé ÂÎÇ ïî äàííîìó âîïðîñó, âñå âàêöèíû ïðîòèâ ÂÃÂ, ïðîèçâîäèìûå â ìèðå, ÿâëÿþòñÿ èììóíîëîãè÷åñêè ñîïîñòàâèìûìè è ìîãóò áûòü âçàèìîçàìåíÿåìûìè
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    . Òîãî æå ìíåíèÿ ïðèäåðæèâàþòñÿ ðåãóëèðóþùèå îðãàíû çäðàâîîõðàíåíèÿ ðÿäà ñòðàí, êîòîðûå âêëþ÷àþò èíôîðìàöèþ î âçàèìîçàìåíÿåìîñòè âàêöèí ïðîòèâ Âàâ ðóêîâîäÿùèå äîêóìåíòû è ðåêîìåíäàöèè ïî èììóíîïðîôèëàêòèêå.