The 12 references with contexts in paper A. Kozlovich V., V. Kotikov N., L. Korsun V., S. Kalinichev A., А. Козлович В., В. Котиков Н., Л. Корсун В., С. Калиничев А. (2018) “Анализ международного опыта по созданию информационно-аналитических баз стандартных образцов // Analysis of international experience in creating reference standards databases” / spz:neicon:vedomostincesmp:y:2017:i:4:p:242-250

1
Federal Law of the Russian Federation of 12.04.2010, No. 61-FZ «On Circulation of Medicines». Available from: https://goo.gl/ 6Rdb43 (in Russian).
Total in-text references: 1
  1. In-text reference with the coordinate start=2470
    Prefix
    êîíòðîëü êà÷åñòâà èññëåäóåìûõ ëåêàðñòâåííûõ ñðåäñòâ (ËÑ) ñ ïîìîùüþ ôèçèêî-õèìè÷åñêèõ è áèîëîãè÷åñêèõ ìåòîäîâ â öåëÿõ ïîäòâåðæäåíèÿ ñîîòâåòñòâèÿ ËÑ òðåáîâàíèÿì íîðìàòèâíîé äîêóìåíòàöèè, óñòàíîâëåííûì ïðè îñóùåñòâëåíèè ãîñóäàðñòâåííîé ðåãèñòðàöèè, è êîòîðûå ïðèìåíÿþòñÿ äëÿ êàëèáðîâêè ñòàíäàðòíûõ îáðàçöîâ ïðîèçâîäèòåëÿ ËÑ, èñïîëüçóåìûõ äëÿ êîíòðîëÿ êà÷åñòâà è èíûõ öåëåé ïðè îáðàùåíèè ËÑ
    Exact
    [1]
    Suffix
    . ÑÎ èìåþò ïåðâîñòåïåííîå çíà÷åíèå â ñèñòåìå îáåñïå÷åíèÿ åäèíñòâà èçìåðåíèé. Ïðè îòñóòñòâèè ñîîòâåòñòâóþùèõ ýòàëîíîâ â íàöèîíàëüíûõ ìåòðîëîãè÷åñêèõ èíñòèòóòàõ ÑÎ ÿâëÿþòñÿ åäèíñòâåííûì ñðåäñòâîì äëÿ äîñòèæåíèÿ íåîáõîäèìîé òî÷íîñòè èçìåðåíèé, è ïîçâîëÿþò îöåíèâàòü ñîïîñòàâèìîñòü ïîëó÷åííûõ ðåçóëüòàòîâ [2].

2
State Standard R 8.694-2010. State system for ensuring the uniformity of measurements. Standard samples of materials (substances). General statistical principles for determining metrological characteristics. Moscow: Standartinform; 2012 (in Russian).
Total in-text references: 1
  1. In-text reference with the coordinate start=2777
    Prefix
    Ïðè îòñóòñòâèè ñîîòâåòñòâóþùèõ ýòàëîíîâ â íàöèîíàëüíûõ ìåòðîëîãè÷åñêèõ èíñòèòóòàõ ÑÎ ÿâëÿþòñÿ åäèíñòâåííûì ñðåäñòâîì äëÿ äîñòèæåíèÿ íåîáõîäèìîé òî÷íîñòè èçìåðåíèé, è ïîçâîëÿþò îöåíèâàòü ñîïîñòàâèìîñòü ïîëó÷åííûõ ðåçóëüòàòîâ
    Exact
    [2]
    Suffix
    . Ãîñóäàðñòâåííàÿ ôàðìàêîïåÿ Ðîññèéñêîé Ôåäåðàöèè XIII èçäàíèÿ (ÃÔ XIII) â êà÷åñòâå ôàðìàêîïåéíûõ ñòàíäàðòíûõ îáðàçöîâ ïðåäóñìàòðèâàåò èñïîëüçîâàíèå â òîì ÷èñëå ÑÎ çàðóáåæíûõ ôàðìàêîïåé, íàïðèìåð, ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ [3].

3
State Pharmacopoeia of the Russian Federation. XIII ed. V. 1. Moscow; 2015. Available from: http://193.232.7.120/feml/clinical_ref/ pharmacopoeia_1/HTML/#55/z (in Russian).
Total in-text references: 2
  1. In-text reference with the coordinate start=3021
    Prefix
    Ãîñóäàðñòâåííàÿ ôàðìàêîïåÿ Ðîññèéñêîé Ôåäåðàöèè XIII èçäàíèÿ (ÃÔ XIII) â êà÷åñòâå ôàðìàêîïåéíûõ ñòàíäàðòíûõ îáðàçöîâ ïðåäóñìàòðèâàåò èñïîëüçîâàíèå â òîì ÷èñëå ÑÎ çàðóáåæíûõ ôàðìàêîïåé, íàïðèìåð, ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ
    Exact
    [3]
    Suffix
    . Öåëü ðàáîòû— èçó÷åíèå ìåæäóíàðîäíîãî îïûòà ïî ñîçäàíèþ èíôîðìàöèîííî-àíàëèòè÷åñêèõ áàç ñòàíäàðòíûõ îáðàçöîâ. Ñîâðåìåííûé óðîâåíü èíôîðìàòèçàöèè æèçíåííîãî öèêëà ËÑ ïîäðàçóìåâàåò äîñòóï çàèíòåðåñîâàííûõ ëèö ê àêòóàëüíûì íîðìàòèâíûì è ñïðàâî÷íûì äàííûì â îíëàéí-ðåæèìå.

  2. In-text reference with the coordinate start=13157
    Prefix
    ãîñóäàðñòâåííîå áþäæåòíîå ó÷ðåæäåíèå «Íàó÷íûé öåíòð ýêñïåðòèçû ñðåäñòâ ìåäèöèíñêîãî ïðèìåíåíèÿ »Ìèíèñòåðñòâà çäðàâîîõðàíåíèÿ Ðîññèéñêîé Ôåäåðàöèè (ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè) ïðèíèìàåò àêòèâíîå ó÷àñòèå â ïîäãîòîâêå Ãîñóäàðñòâåííîé ôàðìàêîïåè Ðîññèéñêîé Ôåäåðàöèè, îñóùåñòâëÿÿ èíèöèàòèâíóþ äåÿòåëüíîñòü ïî ðàçðàáîòêå è âíåäðåíèþ íîâûõ îáùèõ ôàðìàêîïåéíûõ ñòàòåé è ôàðìàêîïåéíûõ ñòàòåé
    Exact
    [3]
    Suffix
    . Ñôåðà óñòàâíîé äåÿòåëüíîñòè ó÷ðåæäåíèÿ ïðåäîñòàâëÿåò ðåàëüíóþ âîçìîæíîñòü ðàçðàáîòêè, àòòåñòàöèè è ïðèìåíåíèÿ ÑÎ ËÑ.  íàñòîÿùåå âðåìÿ ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè ïðîäóêòèâíî èñïîëüçóåò àâòîìàòèçèðîâàííóþ ñèñòåìó ñáîðà è îáðàáîòêè èíôîðìàöèè î çàêàçàõ íà îòðàñëåâûå ñòàíäàðòíûå îáðàçöû (ÎÑÎ).

4
The National Institute for Biological Standards and Control. Biological reference materials. Available from: https:// goo.gl/AYTHzY.
Total in-text references: 3
  1. In-text reference with the coordinate start=3795
    Prefix
    íà îôèöèàëüíûõ ñàéòàõ EDQM (European Directorate for the Quality of Medicines, Åâðîïåéñêèé äèðåêòîðàò ïî êîíòðîëþ êà÷åñòâà ëåêàðñòâåííûõ ñðåäñòâ è çäðàâîîõðàíåíèÿ), USP (United States Pharmacopeia, Ôàðìàêîïåÿ ÑØÀ) BP (British Pharmacopoeia, Áðèòàíñêàÿ ôàðìàêîïåÿ), NIBSC (National Institute for Biological Standards and Control, Íàöèîíàëüíûé èíñòèòóò áèîëîãè÷åñêèõ ñòàíäàðòîâ è êîíòðîëÿ)
    Exact
    [4]
    Suffix
    . Íà ñåãîäíÿøíèé äåíü â BP íàñ÷èòûâàåòñÿ áîëåå 800 ñòàíäàðòíûõ îáðàçöîâ [5], â USP — áîëåå 3500 [6]. ÂÎÇ åæåãîäíî ïóáëèêóåò êàòàëîã ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ, îðãàíèçàöèåé-õðàíèòåëåì êîòîðûõ ÿâëÿåòñÿ EDQM, à òàêæå ñïèñîê ñòàíäàðòíûõ îáðàçöîâ äðóãèõ ôàðìàêîïåé, êîòîðûå ïðèãîäíû äëÿ èñïîëüçîâàíèÿ â ñîîòâåòñòâèè ñ Ìåæäóíàðîäíîé ôàðìàêîïååé [7].

  2. In-text reference with the coordinate start=14499
    Prefix
    Òàêèì îáðàçîì, ñîçäàíèå èíôîðìàöèîííî-àíàëèòè÷åñêîé áàçû ïî ÑÎ, ñ îäíîé ñòîðîíû, îáóñëîâëåíî íåîáõîäèìîñòüþ ñîâåðøåíñòâîâàíèÿ îðãàíèçàöèè ðàáîò â îáëàñòè ñîçäàíèÿ ÑÎ, óòâåðæäåíèÿ èõ òèïà, òðàíñïîðòèðîâàíèÿ è íîðìàòèâíîé ïðàâîâîé áàçû, à, ñ äðóãîé ñòîðîíû — ïîâûøåíèÿ ýôôåêòèâíîñòè ðàáîòû ÔÃÁÓ «ÍÖÝÑÌÏ» Ìèíçäðàâà Ðîññèè [12]. Ðèñ. 7.Ôðàãìåíò òåìàòè÷åñêîãî îãëàâëåíèÿ êàòàëîãà ÑÎ íà ñàéòå NIBSC
    Exact
    [4]
    Suffix
    Ðèñ. 8.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå NIBSC [4] Íà îñíîâàíèè ïðîâåäåííîãî àíàëèçà îïðåäåëåíû îñíîâíûå èíôîðìàöèîííûå áëîêè, êîòîðûå öåëåñîîáðàçíî âêëþ÷èòü ïðè ðàçðàáîòêå èíôîðìàöèîííîàíàëèòè÷åñêîé áàçû ÑÎ: – íàèìåíîâàíèå ÑÎ (íîìåð ÑÎ, íîìåð ñåðèè); – èñòîðèÿ ÑÎ (ò.å. âîçìîæíîñòü ïðîñëåæèâàòü ìàòåðèàëû, èñïîëüçîâàííûå ïðè àòòåñòàöèè ïðåäûäóùèõ ñåðèé); – ïàêåò ñîïðîâîäèòåëüíûõ äîêóìåíòî

  3. In-text reference with the coordinate start=14558
    Prefix
    ïî ÑÎ, ñ îäíîé ñòîðîíû, îáóñëîâëåíî íåîáõîäèìîñòüþ ñîâåðøåíñòâîâàíèÿ îðãàíèçàöèè ðàáîò â îáëàñòè ñîçäàíèÿ ÑÎ, óòâåðæäåíèÿ èõ òèïà, òðàíñïîðòèðîâàíèÿ è íîðìàòèâíîé ïðàâîâîé áàçû, à, ñ äðóãîé ñòîðîíû — ïîâûøåíèÿ ýôôåêòèâíîñòè ðàáîòû ÔÃÁÓ «ÍÖÝÑÌÏ» Ìèíçäðàâà Ðîññèè [12]. Ðèñ. 7.Ôðàãìåíò òåìàòè÷åñêîãî îãëàâëåíèÿ êàòàëîãà ÑÎ íà ñàéòå NIBSC [4] Ðèñ. 8.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå NIBSC
    Exact
    [4]
    Suffix
    Íà îñíîâàíèè ïðîâåäåííîãî àíàëèçà îïðåäåëåíû îñíîâíûå èíôîðìàöèîííûå áëîêè, êîòîðûå öåëåñîîáðàçíî âêëþ÷èòü ïðè ðàçðàáîòêå èíôîðìàöèîííîàíàëèòè÷åñêîé áàçû ÑÎ: – íàèìåíîâàíèå ÑÎ (íîìåð ÑÎ, íîìåð ñåðèè); – èñòîðèÿ ÑÎ (ò.å. âîçìîæíîñòü ïðîñëåæèâàòü ìàòåðèàëû, èñïîëüçîâàííûå ïðè àòòåñòàöèè ïðåäûäóùèõ ñåðèé); – ïàêåò ñîïðîâîäèòåëüíûõ äîêóìåíòîâ (êòî ÿâëÿåòñÿ ïîñòàâùèêîì îáðàçöà äëÿ àòòåñòàöèè, íàèìåíîâ

5
British Pharmacopoeia. Reference Standards Catalogue. Available from: https:// www.pharmacopoeia.com/Catalogue/Products.
Total in-text references: 4
  1. In-text reference with the coordinate start=3868
    Prefix
    of Medicines, Åâðîïåéñêèé äèðåêòîðàò ïî êîíòðîëþ êà÷åñòâà ëåêàðñòâåííûõ ñðåäñòâ è çäðàâîîõðàíåíèÿ), USP (United States Pharmacopeia, Ôàðìàêîïåÿ ÑØÀ) BP (British Pharmacopoeia, Áðèòàíñêàÿ ôàðìàêîïåÿ), NIBSC (National Institute for Biological Standards and Control, Íàöèîíàëüíûé èíñòèòóò áèîëîãè÷åñêèõ ñòàíäàðòîâ è êîíòðîëÿ) [4]. Íà ñåãîäíÿøíèé äåíü â BP íàñ÷èòûâàåòñÿ áîëåå 800 ñòàíäàðòíûõ îáðàçöîâ
    Exact
    [5]
    Suffix
    , â USP — áîëåå 3500 [6]. ÂÎÇ åæåãîäíî ïóáëèêóåò êàòàëîã ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ, îðãàíèçàöèåé-õðàíèòåëåì êîòîðûõ ÿâëÿåòñÿ EDQM, à òàêæå ñïèñîê ñòàíäàðòíûõ îáðàçöîâ äðóãèõ ôàðìàêîïåé, êîòîðûå ïðèãîäíû äëÿ èñïîëüçîâàíèÿ â ñîîòâåòñòâèè ñ Ìåæäóíàðîäíîé ôàðìàêîïååé [7].

  2. In-text reference with the coordinate start=9146
    Prefix
    Êà÷åñòâåííî ðåàëèçîâàí ìåõàíèçì ïðîñëåæèâàåìîñòè: âî-ïåðâûõ, ïðåäñòàâëåíû ïðåäûäóùèé íîìåð ëîòà è äàòà çàâåðøåíèÿ åãî ñðîêà èñïîëüçîâàíèÿ (òàêèì îáðàçîì ìîæíî ïîäòâåðäèòü ãîäíîñòü ÑÎ íà ìîìåíò ïðîâåäåíèÿ àíàëèçà ñ åãî ó÷àñòèåì); âî-âòîðûõ, èìåþòñÿ ññûëêè íà ÑÎ, êîòîðûå áûëè èñïîëüçîâàíû ïðè àòòåñòàöèè äàííîãî (ðèñ. 4). Íà îôèöèàëüíîì ñàéòå BP
    Exact
    [5]
    Suffix
    ðàçìåùåí êàòàëîã õèìè÷åñêèõ ÑÎ Áðèòàíñêîé ôàðìàêîïåè (British Pharmacopoeia chemical reference substances, BPCRS) (ðèñ. 5). Èíòåðôåéñ ðåñóðñà ïðåäñòàâëÿåò ïåðå÷åíü ðåàëèçóåìîé ïðîäóêöèè, ïàíåëü áûñòðîãî ïåðåìåùåíèÿ ïî êàòàëîãó è èíñòðóìåíòû çàêàçà îáðàçöîâ â «êîðçèíó».

  3. In-text reference with the coordinate start=10367
    Prefix
    è Ëàáîðàòîðèåé Êîìèññèè Áðèòàíñêîé ôàðìàêîïåè (British Pharmacopoeia Commission Laboratory) (ïî áîëüøèíñòâó âîïðîñîâ îòñûëàåò ê ýëåêòðîííîé âåðñèè ìîíîãðàôèè íà âåùåñòâî); – ïàñïîðò áåçîïàñíîñòè íà ÑÎ BP. Ñîäåðæèò ïîäðîáíîå íîìåíêëàòóðíîå îïèñàíèå è ïåðå÷èñëåíèå õàðàêòåðèñòèê ýòàëîííîãî ìàòåðèàëà, óñëîâèÿ ïðèìåíåíèÿ è ïðî÷óþ èíôîðìàöèþ; Ðèñ. 5.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå British Pharmacopoeia
    Exact
    [5]
    Suffix
    – ññûëêà íà ìîíîãðàôèè BP, â êîòîðîé óêàçàí äàííûé îáðàçåö (ìàòåðèàëû äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì, îïëàòèâøèì óñëóãó). Îáùèå ïîäõîäû ê èíôîðìàöèîííîìó îáåñïå÷åíèþ ïîëüçîâàòåëÿ, â öåëîì, àíàëîãè÷íû Ph.

  4. In-text reference with the coordinate start=13659
    Prefix
     íàñòîÿùåå âðåìÿ ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè ïðîäóêòèâíî èñïîëüçóåò àâòîìàòèçèðîâàííóþ ñèñòåìó ñáîðà è îáðàáîòêè èíôîðìàöèè î çàêàçàõ íà îòðàñëåâûå ñòàíäàðòíûå îáðàçöû (ÎÑÎ). ÊîìÐèñ. 6.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå British Pharmacopoeia
    Exact
    [5]
    Suffix
    ìåð÷åñêàÿ ÷àñòü ïðîåêòà (ðèñ. 9) äîñòóïíà âñåì çàèíòåðåñîâàííûì ëèöàì íà ñòðàíèöå îôèöèàëüíîãî ñàéòà îðãàíèçàöèè [11]. Ìåæäó òåì, ñóùåñòâóþùèå ðàçëè÷íîãî ðîäà ðååñòðû ÑÎ íå âñåãäà îáåñïå÷èâàþò ïîäðîáíîé èíôîðìàöèåé îá èõ ôèçèêî-õèìè÷åñêèõ ñâîéñòâàõ è ìåòðîëîãè÷åñêèõ õàðàêòåðèñòèêàõ.

6
United States Pharmacopoeia. Search and Buy Reference Standards. Available from: https:// goo.gl/UMNBVt.
Total in-text references: 6
  1. In-text reference with the coordinate start=3892
    Prefix
    äèðåêòîðàò ïî êîíòðîëþ êà÷åñòâà ëåêàðñòâåííûõ ñðåäñòâ è çäðàâîîõðàíåíèÿ), USP (United States Pharmacopeia, Ôàðìàêîïåÿ ÑØÀ) BP (British Pharmacopoeia, Áðèòàíñêàÿ ôàðìàêîïåÿ), NIBSC (National Institute for Biological Standards and Control, Íàöèîíàëüíûé èíñòèòóò áèîëîãè÷åñêèõ ñòàíäàðòîâ è êîíòðîëÿ) [4]. Íà ñåãîäíÿøíèé äåíü â BP íàñ÷èòûâàåòñÿ áîëåå 800 ñòàíäàðòíûõ îáðàçöîâ [5], â USP — áîëåå 3500
    Exact
    [6]
    Suffix
    . ÂÎÇ åæåãîäíî ïóáëèêóåò êàòàëîã ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ, îðãàíèçàöèåé-õðàíèòåëåì êîòîðûõ ÿâëÿåòñÿ EDQM, à òàêæå ñïèñîê ñòàíäàðòíûõ îáðàçöîâ äðóãèõ ôàðìàêîïåé, êîòîðûå ïðèãîäíû äëÿ èñïîëüçîâàíèÿ â ñîîòâåòñòâèè ñ Ìåæäóíàðîäíîé ôàðìàêîïååé [7].

  2. In-text reference with the coordinate start=6417
    Prefix
    USP íå ÿâëÿåòñÿ ãîñóäàðñòâåííûì îðãàíîì, ïðè ýòîì òåñíî ñîòðóäíè÷àåò ñ ïðàâèòåëüñòâåííûìè ó÷ðåæäåíèÿìè è ðåãóëÿòîðíûìè îðãàíàìè âî âñåì ìèðå. Ñòàíäàðòû USP þðèäè÷åñêè ïðèçíàíû â ÑØÀ è äðóãèõ ñòðàíàõ è èñïîëüçóþòñÿ áîëåå ÷åì â 140 ñòðàíàõ
    Exact
    [6]
    Suffix
    . Ñòàíäàðòíûå îáðàçöû USP òùàòåëüíî ïðîâåðÿþòñÿ è îöåíèâàþòñÿ íåñêîëüêèìè íåçàâèñèìûìè ëàÐèñ. 1.Ôðàãìåíò êàòàëîãà ÑÎ (ðåçóëüòàò ïîèñêà ïî ôðàãìåíòó íàçâàíèÿ) íà ñàéòå Ph. Eur. [9] Ðèñ. 2.Ïðèìåð îôîðìëåíèÿ äåòàëüíîãî îïèñàíèÿ ÔÑÎ íà ñàéòå Ph.

  3. In-text reference with the coordinate start=6987
    Prefix
    Ñòàíäàðòíûå îáðàçöû USP òùàòåëüíî ïðîâåðÿþòñÿ è îöåíèâàþòñÿ íåñêîëüêèìè íåçàâèñèìûìè ëàÐèñ. 1.Ôðàãìåíò êàòàëîãà ÑÎ (ðåçóëüòàò ïîèñêà ïî ôðàãìåíòó íàçâàíèÿ) íà ñàéòå Ph. Eur. [9] Ðèñ. 2.Ïðèìåð îôîðìëåíèÿ äåòàëüíîãî îïèñàíèÿ ÔÑÎ íà ñàéòå Ph. Eur. [9] Ðèñ. 3.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå USP
    Exact
    [6]
    Suffix
    Ðèñ. 4.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå USP [6] áîðàòîðèÿìè äëÿ ïîäòâåðæäåíèÿ òî÷íîñòè è âîñïðîèçâîäèìîñòè ïîëó÷åííûõ ðåçóëüòàòîâ.  íàñòîÿùåå âðåìÿ USP ïðåäëàãàåò áîëåå 3500 ÑÎ ôàðìàöåâòè÷åñêèõ ñóáñòàíöèé, âñïîìîãàòåëüíûõ âåùåñòâ, ïðèìåñåé, ïèùåâûõ èíãðåäèåíòîâ, ïðîäóêòîâ ðàçëîæåíèÿ, ïèùåâûõ äîáàâîê, ôàðìàêîïåéíûõ ðåàêòèâîâ è äð.

  4. In-text reference with the coordinate start=7044
    Prefix
    Ñòàíäàðòíûå îáðàçöû USP òùàòåëüíî ïðîâåðÿþòñÿ è îöåíèâàþòñÿ íåñêîëüêèìè íåçàâèñèìûìè ëàÐèñ. 1.Ôðàãìåíò êàòàëîãà ÑÎ (ðåçóëüòàò ïîèñêà ïî ôðàãìåíòó íàçâàíèÿ) íà ñàéòå Ph. Eur. [9] Ðèñ. 2.Ïðèìåð îôîðìëåíèÿ äåòàëüíîãî îïèñàíèÿ ÔÑÎ íà ñàéòå Ph. Eur. [9] Ðèñ. 3.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå USP [6] Ðèñ. 4.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå USP
    Exact
    [6]
    Suffix
    áîðàòîðèÿìè äëÿ ïîäòâåðæäåíèÿ òî÷íîñòè è âîñïðîèçâîäèìîñòè ïîëó÷åííûõ ðåçóëüòàòîâ.  íàñòîÿùåå âðåìÿ USP ïðåäëàãàåò áîëåå 3500 ÑÎ ôàðìàöåâòè÷åñêèõ ñóáñòàíöèé, âñïîìîãàòåëüíûõ âåùåñòâ, ïðèìåñåé, ïèùåâûõ èíãðåäèåíòîâ, ïðîäóêòîâ ðàçëîæåíèÿ, ïèùåâûõ äîáàâîê, ôàðìàêîïåéíûõ ðåàêòèâîâ è äð.

  5. In-text reference with the coordinate start=7732
    Prefix
    USP òàêæå ïðåäîñòàâëÿåò ÑÎ, ïåðå÷èñëåííûå â Êîäåêñå ïèùåâûõ õèìè÷åñêèõ âåùåñòâ (Food Chemicals Codex), è àóòåíòè÷íûå âåùåñòâà, ÿâëÿþùèåñÿ âûñîêîêà÷åñòâåííûìè õèìè÷åñêèìè ýòàëîíàìè, äëÿ èñïîëüçîâàíèÿ àíàëèòè÷åñêèìè, êëèíè÷åñêèìè, ôàðìàöåâòè÷åñêèìè è èññëåäîâàòåëüñêèìè ëàáîðàòîðèÿìè
    Exact
    [6]
    Suffix
    .  ðàçäåëå «Reference Standards »íà ñàéòå USP [6] ïðåäñòàâëåíî íåñêîëüêî òåìàòè÷åñêèõ ñòðàíèö, îïèñûâàþùèõ ÑÎ USP, ññûëêè äëÿ çàãðóçêè ïîëíîãî òàáëè÷íîãî ïåðå÷íÿ ðåàëèçóåìûõ ñòàíäàðòíûõ îáðàçöîâ. Èíòåðàêòèâíàÿ ôîðìà ðàáîòû ñ êàòàëîãîì ïðåäñòàâëåíà â èíäèâèäóàëüíîì ïîäðàçäåëå.

  6. In-text reference with the coordinate start=7781
    Prefix
    USP òàêæå ïðåäîñòàâëÿåò ÑÎ, ïåðå÷èñëåííûå â Êîäåêñå ïèùåâûõ õèìè÷åñêèõ âåùåñòâ (Food Chemicals Codex), è àóòåíòè÷íûå âåùåñòâà, ÿâëÿþùèåñÿ âûñîêîêà÷åñòâåííûìè õèìè÷åñêèìè ýòàëîíàìè, äëÿ èñïîëüçîâàíèÿ àíàëèòè÷åñêèìè, êëèíè÷åñêèìè, ôàðìàöåâòè÷åñêèìè è èññëåäîâàòåëüñêèìè ëàáîðàòîðèÿìè [6].  ðàçäåëå «Reference Standards »íà ñàéòå USP
    Exact
    [6]
    Suffix
    ïðåäñòàâëåíî íåñêîëüêî òåìàòè÷åñêèõ ñòðàíèö, îïèñûâàþùèõ ÑÎ USP, ññûëêè äëÿ çàãðóçêè ïîëíîãî òàáëè÷íîãî ïåðå÷íÿ ðåàëèçóåìûõ ñòàíäàðòíûõ îáðàçöîâ. Èíòåðàêòèâíàÿ ôîðìà ðàáîòû ñ êàòàëîãîì ïðåäñòàâëåíà â èíäèâèäóàëüíîì ïîäðàçäåëå.

7
World Health Organization. International Chemical Reference Substances. Available from: https:// goo.gl/8tfBJS.
Total in-text references: 1
  1. In-text reference with the coordinate start=4144
    Prefix
    ÂÎÇ åæåãîäíî ïóáëèêóåò êàòàëîã ìåæäóíàðîäíûõ ñòàíäàðòíûõ îáðàçöîâ, îðãàíèçàöèåé-õðàíèòåëåì êîòîðûõ ÿâëÿåòñÿ EDQM, à òàêæå ñïèñîê ñòàíäàðòíûõ îáðàçöîâ äðóãèõ ôàðìàêîïåé, êîòîðûå ïðèãîäíû äëÿ èñïîëüçîâàíèÿ â ñîîòâåòñòâèè ñ Ìåæäóíàðîäíîé ôàðìàêîïååé
    Exact
    [7]
    Suffix
    .  2016 ãîäó êîëè÷åñòâî ÑÎ, êîòîðûå îïèñàíû â ìîíîãðàôèÿõ Ph. Eur. (European Pharmacopoeia,Åâðîïåéñêàÿ ôàðìàêîïåÿ), ñîñòàâëÿëî îêîëî 3000. Ïîñëå èñïûòàíèé â ëàáîðàòîðèè ìàòåðèàëû, ïðåäëàãàåìûå äëÿ èñïîëüçîâàíèÿ â êà÷åñòâå ÑÎ, óòâåðæäàþòñÿ Êîìèññèåé Åâðîïåéñêîé ôàðìàêîïåè, ïîñëå ÷åãî, ïîëó÷èâ ñòàòóñ îôèöèàëüíûõ ÑÎ, ïîñòóïàþò â Îòäåë ñòàíäàðòíûõ îáðàçöîâ (Reference Standards and Samples Divisio

8
Keitel S. The European Pharmacopoeia: bringing pharmaceutical standard harmonization to Europe. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2016; (2): 8–14 (in Russian).
Total in-text references: 2
  1. In-text reference with the coordinate start=4794
    Prefix
     íàñòîÿùåå âðåìÿ óòâåðæäàþòñÿ õèìè÷åñêèå ñòàíäàðòíûå îáðàçöû (CRS), áèîëîãè÷åñêèå ñòàíäàðòíûå îáðàçöû (BRP), à òàêæå ñòàíäàðòíûå ñïåêòðû äëÿ èñïûòàíèé è àíàëèçîâ, âûïîëíÿåìûõ â ñîîòâåòñòâèè ñ îôèöèàëüíûìè ìåòîäàìè, îïèñàííûìè â Ph. Eur.
    Exact
    [8]
    Suffix
    . Ñ 1992 ã. ââåäåíà ïðîöåäóðà ñîîòâåòñòâèÿ òðåáîâàíèÿì ìîíîãðàôèé Ph. Eur. Ñåðòèôèêàò ñîîòâåòñòâèÿ (Certificates of Suitability to the Monographs of the European Pharmacopoeia, CEP), âûäàííûé EDQM, ïîäòâåðæäàåò, ÷òî êà÷åñòâî ñóáñòàíöèè êîíòðîëèðóåòñÿ â ñîîòâåòñòâèè ñ òðåáîâàíèÿìè ñîîòâåòñòâóþùåé ìîíîãðàôèè Ph.

  2. In-text reference with the coordinate start=5316
    Prefix
    Ñåðòèôèêàò ñîîòâåòñòâèÿ (Certificates of Suitability to the Monographs of the European Pharmacopoeia, CEP), âûäàííûé EDQM, ïîäòâåðæäàåò, ÷òî êà÷åñòâî ñóáñòàíöèè êîíòðîëèðóåòñÿ â ñîîòâåòñòâèè ñ òðåáîâàíèÿìè ñîîòâåòñòâóþùåé ìîíîãðàôèè Ph. Eur. è ìîæåò èñïîëüçîâàòüñÿ â êà÷åñòâå çàìåíû ïîäðîáíîé èíôîðìàöèè, óêàçûâàåìîé â çàÿâêå íà ïîëó÷åíèå ðåãèñòðàöèîííîãî óäîñòîâåðåíèÿ ËÑ
    Exact
    [8]
    Suffix
    . Ñòðàíèöà ñàéòà EDQM «Ph. Eur. Reference Standards: Orders &Catalogue »ïðåäîñòàâëÿåò ïîëüçîâàòåëÿì âîçìîæíîñòü ñâîáîäíîãî äîñòóïà ê åæåäíåâíî îáíîâëÿþùèìñÿ êàòàëîãó ÑÎ â ôîðìàòå PDF è áàçå äàííûõ ÑÎ â ðåæèìå îíëàéí (ðèñ. 1).

9
European Directorate for the Quality of Medicines. Reference Substances. Available from: https:// goo.gl/VLo2zh.
Total in-text references: 2
  1. In-text reference with the coordinate start=6751
    Prefix
    Ñòàíäàðòû USP þðèäè÷åñêè ïðèçíàíû â ÑØÀ è äðóãèõ ñòðàíàõ è èñïîëüçóþòñÿ áîëåå ÷åì â 140 ñòðàíàõ [6]. Ñòàíäàðòíûå îáðàçöû USP òùàòåëüíî ïðîâåðÿþòñÿ è îöåíèâàþòñÿ íåñêîëüêèìè íåçàâèñèìûìè ëàÐèñ. 1.Ôðàãìåíò êàòàëîãà ÑÎ (ðåçóëüòàò ïîèñêà ïî ôðàãìåíòó íàçâàíèÿ) íà ñàéòå Ph. Eur.
    Exact
    [9]
    Suffix
    Ðèñ. 2.Ïðèìåð îôîðìëåíèÿ äåòàëüíîãî îïèñàíèÿ ÔÑÎ íà ñàéòå Ph. Eur. [9] Ðèñ. 3.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå USP [6] Ðèñ. 4.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå USP [6] áîðàòîðèÿìè äëÿ ïîäòâåðæäåíèÿ òî÷íîñòè è âîñïðîèçâîäèìîñòè ïîëó÷åííûõ ðåçóëüòàòîâ.

  2. In-text reference with the coordinate start=6821
    Prefix
    Ñòàíäàðòíûå îáðàçöû USP òùàòåëüíî ïðîâåðÿþòñÿ è îöåíèâàþòñÿ íåñêîëüêèìè íåçàâèñèìûìè ëàÐèñ. 1.Ôðàãìåíò êàòàëîãà ÑÎ (ðåçóëüòàò ïîèñêà ïî ôðàãìåíòó íàçâàíèÿ) íà ñàéòå Ph. Eur. [9] Ðèñ. 2.Ïðèìåð îôîðìëåíèÿ äåòàëüíîãî îïèñàíèÿ ÔÑÎ íà ñàéòå Ph. Eur.
    Exact
    [9]
    Suffix
    Ðèñ. 3.Ôðàãìåíò êàòàëîãà ÑÎ íà ñàéòå USP [6] Ðèñ. 4.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå USP [6] áîðàòîðèÿìè äëÿ ïîäòâåðæäåíèÿ òî÷íîñòè è âîñïðîèçâîäèìîñòè ïîëó÷åííûõ ðåçóëüòàòîâ.  íàñòîÿùåå âðåìÿ USP ïðåäëàãàåò áîëåå 3500 ÑÎ ôàðìàöåâòè÷åñêèõ ñóáñòàíöèé, âñïîìîãàòåëüíûõ âåùåñòâ, ïðèìåñåé, ïèùåâûõ èíãðåäèåíòîâ, ïðîäóêòîâ ðàçëîæåíèÿ, ïèùåâûõ äîáàâîê, ôàðìàêîïåéíûõ ðåàêòèâîâ è äð.

10
Borisevich IV, Petukhov VG, Volkova RA, Ustinnikova OB, Fadeikina OV, Malkova VI. Standard samples as a tool to provide metrology of analytical methods of immunobiological medicines (IM) monitoring. BIOpreparations. Prevention, Diagnosis, Treatment 2010; (4): 8–10 (in Russian).
Total in-text references: 1
  1. In-text reference with the coordinate start=11153
    Prefix
    Ó÷ðåæäåíèå ïîëó÷èëî ñòàòóñ Ìåæäóíàðîäíîé ëàáîðàòîðèè áèîëîãè÷åñêèõ ñòàíäàðòîâ ÂÎÇ è ïî ñåé äåíü ÿâëÿåòñÿ îôèöèàëüíîé Ëàáîðàòîðèåé êîíòðîëÿ ìåäèöèíñêèõ ïðåïàðàòîâ â Åâðîïå è Àíãëèè. Îí ïðîèçâîäèò áîëåå 90 % ìåæäóíàðîäíûõ ÑÎ äëÿ øèðîêîãî ñïåêòðà ãðóïï âåùåñòâ, âêëþ÷àÿ àíòèáèîòèêè, ôåðìåíòû, èììóíîáèîëîãè÷åñêèå ïðåïàðàòû, âèðóñíûå ïðåïàðàòû è êîìïîíåíòû êðîâè
    Exact
    [10]
    Suffix
    . Èíòåðàêòèâíûé êàòàëîã ïðîäóêöèè ðàçìåùåí íà ñàéòå ó÷ðåæäåíèÿ â ðàçäåëå «Biological reference materials»; ïîñåòèòåëü ðåñóðñà ìîæåò èçó÷èòü ïîëíûé ñïèñîê çàïèñåé, ïðîêðó÷èâàÿ ñòðàíèöó, âîñïîëüçîâàòüñÿ íàâèãàöèîííî-ïîèñêîâîé ñèñòåìîé áðàóçåðà èëè ñàéòà.

11
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation. Expertise. Provision with standard samples and pathogenic strains. Available from: http://www.regmed.ru (in Russian).
Total in-text references: 2
  1. In-text reference with the coordinate start=13779
    Prefix
     íàñòîÿùåå âðåìÿ ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè ïðîäóêòèâíî èñïîëüçóåò àâòîìàòèçèðîâàííóþ ñèñòåìó ñáîðà è îáðàáîòêè èíôîðìàöèè î çàêàçàõ íà îòðàñëåâûå ñòàíäàðòíûå îáðàçöû (ÎÑÎ). ÊîìÐèñ. 6.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå British Pharmacopoeia [5] ìåð÷åñêàÿ ÷àñòü ïðîåêòà (ðèñ. 9) äîñòóïíà âñåì çàèíòåðåñîâàííûì ëèöàì íà ñòðàíèöå îôèöèàëüíîãî ñàéòà îðãàíèçàöèè
    Exact
    [11]
    Suffix
    . Ìåæäó òåì, ñóùåñòâóþùèå ðàçëè÷íîãî ðîäà ðååñòðû ÑÎ íå âñåãäà îáåñïå÷èâàþò ïîäðîáíîé èíôîðìàöèåé îá èõ ôèçèêî-õèìè÷åñêèõ ñâîéñòâàõ è ìåòðîëîãè÷åñêèõ õàðàêòåðèñòèêàõ. Òàêèì îáðàçîì, ñîçäàíèå èíôîðìàöèîííî-àíàëèòè÷åñêîé áàçû ïî ÑÎ, ñ îäíîé ñòîðîíû, îáóñëîâëåíî íåîáõîäèìîñòüþ ñîâåðøåíñòâîâàíèÿ îðãàíèçàöèè ðàáîò â îáëàñòè ñîçäàíèÿ ÑÎ, óòâåðæäåíèÿ èõ òèïà, òðàíñïîðòèðîâàíèÿ è íîðìàòèâíîé ïðàâîâîé áàçû

  2. In-text reference with the coordinate start=15986
    Prefix
    áëîê ñ ðàñ÷åòíûìè ôîðìóëàìè; – ìàêåò ýòèêåòêè ïåðâè÷íîé/âòîðè÷íîé óïàêîâêè; – îò÷åò ïî àòòåñòàöèè/ïåðåàòòåñòàöèè; – ïðîãðàììà èñïûòàíèé (äîëæíà âêëþ÷àòü â òîì ÷èñëå ðåçóëüòàòû èñïûòàíèé ïî âñåì ïîêàçàòåëÿì ïðåäïîëàãàåìîãî ÑÎ, íåçàâèñèìî îò òîãî, áóäóò ëè ðåçóëüòàòû îòðàæåíû íà ýòèêåòêå èëè íåò). Ðèñ. 9.Ôðàãìåíò ïåðå÷íÿ ðåàëèçóåìûõ îòðàñëåâûõ ñòàíäàðòíûõ îáðàçöîâ ÔÃÁÓ «ÍÖÝÑÌÏ» Ìèíçäðàâà Ðîññèè
    Exact
    [11]
    Suffix
    Ðåçóëüòàòû ïðîâåäåííîé ðàáîòû ïîçâîëèëè îöåíèòü ñóùåñòâóþùèå ìåæäóíàðîäíûå ïîäõîäû ê ñîçäàíèþ áàç äàííûõ ÑÎ è áûëè èñïîëüçîâàíû äëÿ ñîçäàíèÿ èíôîðìàöèîííî-àíàëèòè÷åñêîé áàçû ÑÎ. Ðàçðàáîòêà è âíåäðåíèå òàêîé áàçû áóäóò ñïîñîáñòâîâàòü ñîâåðøåíñòâîâàíèþ îðãàíèçàöèè ðàáîò â îáëàñòè ñîçäàíèÿ è ñèñòåìàòèçàöèè äàííûõ î ÑÎ è ïîâûøåíèþ ýôôåêòèâíîñòè ðàáîòû ÔÃÁÓ «ÍÖÝÑÌÏ» Ìèíçäðàâà Ðîññèè.

12
Improvement of the system of development and application of standard samples intended for assessing the quality, efficacy and safety of medicinal products. Research report (intermediate). FSBI «SCEEMP» of the Ministry of Health of Russia; advisors: Sakanyan EI, Klimov VI, Volkova RA; prepared by: Yashkir VA, Fadeikina OV. Mos-
Total in-text references: 1
  1. In-text reference with the coordinate start=14272
    Prefix
    Òàêèì îáðàçîì, ñîçäàíèå èíôîðìàöèîííî-àíàëèòè÷åñêîé áàçû ïî ÑÎ, ñ îäíîé ñòîðîíû, îáóñëîâëåíî íåîáõîäèìîñòüþ ñîâåðøåíñòâîâàíèÿ îðãàíèçàöèè ðàáîò â îáëàñòè ñîçäàíèÿ ÑÎ, óòâåðæäåíèÿ èõ òèïà, òðàíñïîðòèðîâàíèÿ è íîðìàòèâíîé ïðàâîâîé áàçû, à, ñ äðóãîé ñòîðîíû — ïîâûøåíèÿ ýôôåêòèâíîñòè ðàáîòû ÔÃÁÓ «ÍÖÝÑÌÏ» Ìèíçäðàâà Ðîññèè
    Exact
    [12]
    Suffix
    . Ðèñ. 7.Ôðàãìåíò òåìàòè÷åñêîãî îãëàâëåíèÿ êàòàëîãà ÑÎ íà ñàéòå NIBSC [4] Ðèñ. 8.Îôîðìëåíèå ïîäðîáíîãî îïèñàíèÿ ÑÎ íà ñàéòå NIBSC [4] Íà îñíîâàíèè ïðîâåäåííîãî àíàëèçà îïðåäåëåíû îñíîâíûå èíôîðìàöèîííûå áëîêè, êîòîðûå öåëåñîîáðàçíî âêëþ÷èòü ïðè ðàçðàáîòêå èíôîðìàöèîííîàíàëèòè÷åñêîé áàçû ÑÎ: – íàèìåíîâàíèå ÑÎ (íîìåð ÑÎ, íîìåð ñåðèè); – èñòîðèÿ ÑÎ (ò.å. âîçìîæíîñòü ïðîñëåæèâàòü ìàòåðèàëû, èñïîëüçîâà