The 15 references with contexts in paper N. Neugodova P., M. Ryabtseva S., G. Sapozhnikova A., Н. Неугодова П., М. Рябцева С., Г. Сапожникова А. (2018) “Основные требования к биологическим показателям при оценке качества лекарственных средств. Возможности валидации биологических методов контроля // Basic requirements for biological criteria in drug quality evaluation. validation of biological control methods” / spz:neicon:vedomostincesmp:y:2016:i:3:p:3-8

1
Severtsev VA, Mashkovskiy MD, Bagirova VL, et al. Guidelines for the introduction of the section «pyrogen test» in the technical documentation for the newly developed injectable drugs, as well as water and other fluids used in their manufacture, and articles, which touch or that contain solutions for injection. Guidelines. Moscow; 1990 (in Russian).
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    Ïðè ýòîì òðåáîâàíèÿ ê âûáîðó íàäåæíîãî óðîâíÿ íîðì êà÷åñòâà ËÑ íà ïðîòÿæåíèè äëèòåëüíîãî ïåðèîäà âðåìåíè íå áûëè çàêðåïëåíû äîêóìåíòàëüíî, à ñîäåðæàëèñü â ìåòîäè÷åñêèõ óêàçàíèÿõ è íîñèëè ðåêîìåíäàòåëüíûé õàðàêòåð
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    . Íàñåãîäíÿøíèéäåíüâåäåòñÿàêòèâíàÿðàáîòàïî àêòóàëèçàöèè íîðìàòèâíî-ïðàâîâîé áàçû â îáëàñòè êîíòðîëÿ êà÷åñòâà ËÑ.  ðàìêàõ ïîäãîòîâêè XIII èçäàíèÿ ÃÔ ÐÔ âíåñåíû íåêîòîðûå óòî÷íåíèÿ óñëîâèé âûïîëíåíèÿ èñïûòàíèé ïî áèîëîãè÷åñêèì ïîêàçàòåëÿì.

2
Yurgel NV, Kosenko VV, Davydova KS, Budanov SV, Bagirova VL, Kovaleva EL, et al. Rules of compilation, presentation and design quality standards for pharmaceutical substances. Guidelines. Moscow; 2009 (in Russian).
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  1. In-text reference with the coordinate start=5911
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    Ïðè ýòîì òðåáîâàíèÿ ê âûáîðó íàäåæíîãî óðîâíÿ íîðì êà÷åñòâà ËÑ íà ïðîòÿæåíèè äëèòåëüíîãî ïåðèîäà âðåìåíè íå áûëè çàêðåïëåíû äîêóìåíòàëüíî, à ñîäåðæàëèñü â ìåòîäè÷åñêèõ óêàçàíèÿõ è íîñèëè ðåêîìåíäàòåëüíûé õàðàêòåð
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    . Íàñåãîäíÿøíèéäåíüâåäåòñÿàêòèâíàÿðàáîòàïî àêòóàëèçàöèè íîðìàòèâíî-ïðàâîâîé áàçû â îáëàñòè êîíòðîëÿ êà÷åñòâà ËÑ.  ðàìêàõ ïîäãîòîâêè XIII èçäàíèÿ ÃÔ ÐÔ âíåñåíû íåêîòîðûå óòî÷íåíèÿ óñëîâèé âûïîëíåíèÿ èñïûòàíèé ïî áèîëîãè÷åñêèì ïîêàçàòåëÿì.

3
State register of medicines. V. II, parts 1 and 2. Moscow: Official publication; 2009 (in Russian).
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    ýíäîòîêñèíà (ÅÝ) íà ìã, ìë, ÌÅ èëè åäèíèöó óïàêîâêè, îïðåäåëÿåòñÿ ñïîñîáîì ââåäåíèÿ ËÏ â îðãàíèçìèçàâèñèòîòêîëè÷åñòâàýíäîòîêñèíà,êîòîðîå ÷åëîâåêìîæåòïîëó÷èòüýòèìñïîñîáîìáåçïàòîëîãè÷åñêèõ ïîñëåäñòâèé. Ïðè ðàñ÷åòå íîðìû íåîáõîäèìî ïðîâåðÿòü ñîîòâåòñòâèå äîç, óêàçàííûõ â èíñòðóêöèè ïî ìåäèöèíñêîìó ïðèìåíåíèþ íà êîíêðåòíûé ËÏ è òèïîâîé êëèíèêî-ôàðìàêîëîãè÷åñêîé ñòàòüå Ãîñóäàðñòâåííîãî ðååñòðà ËÑ
    Exact
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    . ÂíîâîéðåäàêöèèÎÔÑíîðìàñîäåðæàíèÿáàêòåðèàëüíûõ ýíäîòîêñèíîâ äëÿ ËÏ, äîçèðóåìûõ íà ì2 ïîâåðõíîñòè òåëà, ñíèæåíà äî 100 ÅÝ/ì2. Óæåñòî÷åíèå äàííîé íîðìû ïðîäèêòîâàíî òåì, ÷òî ïîäîáíàÿ ñèñòåìà äîçèðîâàíèÿ ïðèìåíÿåòñÿ, êàê ïðàâèëî, äëÿ ïðîòèâîîïóõîëåâûõ ïðåïàðàòîâ èëè ïðåïàðàòîâ äëÿ ëå÷åíèÿ àóòîèììóííûõ èëè ñèñòåìíûõ çàáîëåâàíèé, êîòîðûå ïðèìåíÿþòñÿ â êîìïëåêñíîé òåðàïèè ñ äðóãèìè èíúåêöèîííûìè ïðåïàð

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    Âîòäåëüíûõñëó÷àÿõñòàíäàðòíàÿïðîáîïîäãîòîâêàñèñïîëüçîâàíèåìâîäûäëÿËÀË-òåñòàíåïîçâîëÿåòâûïîëíèòüòåñòèïîëó÷èòüàäåêâàòíûåðåçóëüòàòû. ×àùå âñåãî òàêèå ïðîáëåìû âîçíèêàþò äëÿ âîäîíåðàñòâîðèìûõ ñóáñòàíöèé. Íàïðèìåð, âèíïîöåòèí è ðèôàìïèöèí òðåáóþò ïðèãîòîâëåíèÿ ðàñòâîðèòåëÿ ïîñïåöèàëüíîéïðîïèñè,àòàêèåñóáñòàíöèè,êàêäîöåòàêñåë, ôëóôåíàçèí, âîðèêîíàçîë è äð. õîðîøî ðàñòâîðÿþòñÿ â ýòèëîâîì ñïèðòå
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    [3–5]
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    . Òàêæå ñëîæíîñòè âîçíèêàþò ïðè èñïûòàíèè ïðîëîíãèðîâàííûõ ôîðì ËÏ, ñîäåðæàùèõ ìèêðîñôåðû èëè èìïëàíòû, èëè ìàñëÿíûå ðàñòâîðû [6].  ñëó÷àå íåñòàíäàðòíîé ïðîáîïîäãîòîâêè äîëæíû áûòü ïðåäñòàâëåíû âàëèäàöèîííûå ìàòåðèàëû ïî ïîäáîðó óñëîâèé.

6
Shapovalova OV, Dolgova GV, Neugodova NP, Sapozhnikova GA. The use of organic solvents to determine of «Bacterial endotoxins» index in the water-insoluble pharmaceutical substances. Antibiotiki i himioterapiya 2013; (9): 41–4 (in Russian).
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    Íàïðèìåð, âèíïîöåòèí è ðèôàìïèöèí òðåáóþò ïðèãîòîâëåíèÿ ðàñòâîðèòåëÿ ïîñïåöèàëüíîéïðîïèñè,àòàêèåñóáñòàíöèè,êàêäîöåòàêñåë, ôëóôåíàçèí, âîðèêîíàçîë è äð. õîðîøî ðàñòâîðÿþòñÿ â ýòèëîâîì ñïèðòå [3–5]. Òàêæå ñëîæíîñòè âîçíèêàþò ïðè èñïûòàíèè ïðîëîíãèðîâàííûõ ôîðì ËÏ, ñîäåðæàùèõ ìèêðîñôåðû èëè èìïëàíòû, èëè ìàñëÿíûå ðàñòâîðû
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    .  ñëó÷àå íåñòàíäàðòíîé ïðîáîïîäãîòîâêè äîëæíû áûòü ïðåäñòàâëåíû âàëèäàöèîííûå ìàòåðèàëû ïî ïîäáîðó óñëîâèé. Ìåòîäèêàðàñòâîðåíèÿäîëæíàáûòüïîäðîáíîîïèñàíàâòåêñòå ðàçäåëà. 3. Óêàçàíèå íà àëüòåðíàòèâíîñòü òåñòîâ «Ïèðîãåííîñòü» è «Áàêòåðèàëüíûå ýíäîòîêñèíû».

7
Merkulova YuV, Dolgova GV, Neugodova NP, Chayka LA, Gomon ON, Shapovalova OV. Properties of the test to bacterial endotoxins of medicines in the form of oily solutions. Farmakom 2008; (1): 67–73 (in Russian).
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    Âåëè÷èíóòåñò-äîçûäëÿêàæäîãîêîíêðåòíîãîËÑ ñëåäóåò îïðåäåëÿòü íà ýòàïå äîêëèíè÷åñêèõ (íåêëèíè÷åñêèõ) èññëåäîâàíèé, ïðè èçó÷åíèè îñòðîé òîêñè÷íîñòèíàìûøàõ,ïðèîïðåäåëåíèèòîêñèêîìåòðè÷åñêèõ ïîêàçàòåëåé
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    [7, 8]
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    . Ïðè âûáîðå òåñò-äîçû íåîáõîäèìî èñõîäèòü èç âåëè÷èíû ìàêñèìàëüíî ïåðåíîñèìîé äîçû (ÌÏÄ), êîòîðàÿ áëèçêà ê ËÄ10. Èìåííî íà ýòîé âåëè÷èíå îñíîâàí ôàðìàêîïåéíûé ìåòîä «Àíîìàëüíàÿ òîêñè÷íîñòü» — îñíîâíîé òåñò, êîòîðûéäîïóñêàåòãèáåëü1èç10æèâîòíûõ,âçÿòûõâ èñïûòàíèå (ò.å. îáùåå êîëè÷åñòâî ïîãèáøèõ æèâîòíûõ â äâóõ ïîñòàíîâêàõ äîëæíî ñîñòàâëÿòü íå áîëåå 10 % îò îáùåãî ÷èñëà èñïîëüçîâàííûõ æèâîòíûõ).

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    Ýòî ïðåäïîëàãàåò ýêñïåðèìåíòàëüíîå îïðåäåëåíèå ïåðåíîñèìîñòè äîç — ò.í. «ðàñòèòðîâêó» ËÑ â âûáðàííûõ óñëîâèÿõ ñ öåëüþ îïðåäåëåíèÿ ìàêñèìàëüíîé ïåðåíîñèìîé äîçû èëè ìàêñèìàëüíîé âîçìîæíîé (â ñëó÷àå íàëè÷èÿ òåõíè÷åñêèõ îãðàíè÷åíèé â âûïîëíåíèè òåñòà)
    Exact
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    . Ïîñêîëüêó âàëèäàöèÿ òåñò-îáúåêòà, â êà÷åñòâå êîòîðîãî âûñòóïàþò æèâîòíûå, íåâîçìîæíà, à äîïîëíèòåëüíàÿ ïîñòàíîâêà ïîëîæèòåëüíîãî è îòðèöàòåëüíîãîêîíòðîëåéïðîòèâîðå÷èòïðèíöèïàìãóìàííîãî îáðàùåíèÿ ñ æèâîòíûìè, èñïîëüçóåòñÿ ïîäòâåðæäåíèå ïðèåìëåìîñòè óñëîâèé èñïûòàíèé.

8
Pershin GN. Methods of experimental chemotherapy. Moscow: Meditsina; 1971 (in Russian).
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    Âåëè÷èíóòåñò-äîçûäëÿêàæäîãîêîíêðåòíîãîËÑ ñëåäóåò îïðåäåëÿòü íà ýòàïå äîêëèíè÷åñêèõ (íåêëèíè÷åñêèõ) èññëåäîâàíèé, ïðè èçó÷åíèè îñòðîé òîêñè÷íîñòèíàìûøàõ,ïðèîïðåäåëåíèèòîêñèêîìåòðè÷åñêèõ ïîêàçàòåëåé
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    . Ïðè âûáîðå òåñò-äîçû íåîáõîäèìî èñõîäèòü èç âåëè÷èíû ìàêñèìàëüíî ïåðåíîñèìîé äîçû (ÌÏÄ), êîòîðàÿ áëèçêà ê ËÄ10. Èìåííî íà ýòîé âåëè÷èíå îñíîâàí ôàðìàêîïåéíûé ìåòîä «Àíîìàëüíàÿ òîêñè÷íîñòü» — îñíîâíîé òåñò, êîòîðûéäîïóñêàåòãèáåëü1èç10æèâîòíûõ,âçÿòûõâ èñïûòàíèå (ò.å. îáùåå êîëè÷åñòâî ïîãèáøèõ æèâîòíûõ â äâóõ ïîñòàíîâêàõ äîëæíî ñîñòàâëÿòü íå áîëåå 10 % îò îáùåãî ÷èñëà èñïîëüçîâàííûõ æèâîòíûõ).

9
Krylov YuF, Kivman GYa. Biological control of drug safety. Moscow: Meditsina; 1985 (in Russian).
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    Ñïîñîá ââåäåíèÿ äîëæåí îáåñïå÷èâàòü ìàêñèìàëüíî æåñòêèå óñëîâèÿ ïðîâåäåíèÿ èñïûòàíèÿ, ò.å. ïðåâîñõîäèòü ïî áèîäîñòóïíîñòè ËÑ òåðàïåâòè÷åñêèé ïóòü ââåäåíèÿ èëè, êàê ìèíèìóì, ñîîòâåòñòâîâàòü åìó. Åñëè âíóòðèñîñóäèñòûé ñïîñîá ââåäåíèÿ íåâîçìîæåí (ñóñïåíçèè, ìàñëÿíûå ðàñòâîðû èò.ï.),òîãäàäîïóñêàåòñÿâíóòðèìûøå÷íûéïóòüââåäåíèÿ
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    . Âíóòðèâåííûé ïóòü ââåäåíèÿ âñåãäà ÿâëÿåòñÿ ïðåäïî÷òèòåëüíûì, ò.ê. îáåñïå÷èâàåò ìàêñèìàëüíóþ áèîäîòóïíîñòü. Ñêîðîñòü ââåäåíèÿ ËÑ íîðìèðóåòñÿ òîëüêî äëÿ âíóòðèñîñóäèñòîãî ïóòè. Ñ ìîìåíòà ââåäåíèÿ â òåêñò ÃÔ ïîêàçàòåëÿ «Àíîìàëüíàÿ òîêñè÷íîñòü» ñêîðîñòü ââåäåíèÿ ñîñòàâëÿåò 0,1 ìë/ñ.

10
Neugodova NP, Dolgova GV, Hayretdinova MN, Pomerantseva TYa, Sapozhnikova GA, Verstakova OL. The procedure of the implementation of pharmaceutical index «Abnormal Toxicity» by the example of antibiotics. Antibiotiki i himioterapiya 2008; 53(7–8): 19–26 (in Russian).
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    , äëÿ êîòîðûõ åùå íå íàêîïëåí áîëüøîéîïûòïðîèçâîäñòâàèïðèìåíåíèÿâêëèíè÷åñêîé ïðàêòèêå, î÷åíü âàæíî ïîìíèòü: «×åì ïîëíåå áóäåò ïðîâåäåí îïûò íà æèâîòíûõ, òåì ìåíåå ÷àñòî áîëüíûìïðèäåòñÿáûòüâïîëîæåíèèîïûòíîãîîáúåêòàñî âñåìè ïå÷àëüíûìè ïîñëåäñòâèÿìè» (È. Ï. Ïàâëîâ). Ïîýòîìó äëÿ íîâûõ îðèãèíàëüíûõ ïðåïàðàòîâ íåîáõîäèìî ïðîâîäèòü îñîáåííî òùàòåëüíî óñòàíîâëåíèå íîðì êà÷åñòâà è óñëîâèé èñïûòàíèÿ ËÑ
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    . ÇÀÊËÞ×ÅÍÈÅ Ïðîâåäåí àíàëèç îñíîâíûõ îøèáîê è íåäî÷åòîâ, âñòðå÷àþùèõñÿ â òåêñòå ðàçäåëîâ ÍÄ íà îòå÷åñòâåííûå è çàðóáåæíûå ËÑ ïî ïîêàçàòåëÿì «Áàêòåðèàëüíûå ýíäîòîêñèíû» è «Àíîìàëüíàÿ òîêñè÷íîñòü», íà îñíîâàíèè ÷åãî ðàçúÿñíåíû òðåáîâàíèÿ äëÿ âûáîðà àäåêâàòíûõ óñëîâèé ïðîâåäåíèÿ èñïûòàíèé, à òàêæå ïîäõîäû ê âûáîðó íàäëåæàùåãî óðîâíÿ íîðì êà÷åñòâà ËÑ.

12
Sharoykina MV, Kovaleva EL, Neugodova NP. Methodical approaches to the estimation of abnormal toxicity cephalosporin antibiotics. Sechenovskiy vestnik 2014;16(2): 111 (in Russian).
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    Óñòàíîâëåííàÿ ñêîðîñòü ÿâëÿåòñÿ îïòèìàëüíîé äëÿ âûïîëíåíèÿ òîêñèêîëîãè÷åñêèõ èñïûòàíèé è ïîçâîëÿåò êîððåëèðîâàòü ðåçóëüòàòû, ïîëó÷åííûå â ðàçíûõ èññëåäîâàòåëüñêèõ ëàáîðàòîðèÿõ. Èçìåíåíèå ñêîðîñòè ââåäåíèÿ ïîòðåáóåò ïåðåñìîòðà âñåõ òåñò-äîç íà ËÑ, ðàçðàáîòàííûå áîëåå ÷åì çà 50 ëåò
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    . Âòîðàÿ ïî ðàñïðîñòðàíåííîñòè ïðîáëåìà â îòíîøåíèè ðàçäåëà «Àíîìàëüíàÿ òîêñè÷íîñòü» — åãîíåîáîñíîâàííîå èñêëþ÷åíèå èç ÍÄ. Íåñìîòðÿ íà òî, ÷òî áðàê ïî ïîêàçàòåëþ «Àíîìàëüíàÿ òîêñè÷íîñòü» íà ñòàäèè ýêñïåðòèçû âûÿâëÿåòñÿäîñòàòî÷íîðåäêî,ïðèìåðíî2–3 ñåðèèËÏâãîä, â ñâåòå ñíèæåíèÿ ÷èñëà ËÑ, êîíòðîëèðóåìûõ ïî äàííîìó ïîêàçàòåëþ, â åâðîïåéñêèõ ñòðàíàõ è ÑØÀ ðåãóëÿðíî âîçíèêàþò ñîîáùåíèÿ î íåæåëàòåëüíûõ ïî

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Neugodova NP, Dolgova GV, Pomerantseva TYa, Hayretdinova MN, Sapozhnikova GA. Effect of parameter «Injection rate» during the test «The test for toxicity». Antibiotiki i himioterapiya 2009; (1): 53–5 (in Russian).
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    Óñòàíîâëåííàÿ ñêîðîñòü ÿâëÿåòñÿ îïòèìàëüíîé äëÿ âûïîëíåíèÿ òîêñèêîëîãè÷åñêèõ èñïûòàíèé è ïîçâîëÿåò êîððåëèðîâàòü ðåçóëüòàòû, ïîëó÷åííûå â ðàçíûõ èññëåäîâàòåëüñêèõ ëàáîðàòîðèÿõ. Èçìåíåíèå ñêîðîñòè ââåäåíèÿ ïîòðåáóåò ïåðåñìîòðà âñåõ òåñò-äîç íà ËÑ, ðàçðàáîòàííûå áîëåå ÷åì çà 50 ëåò
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    [12, 13]
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    . Âòîðàÿ ïî ðàñïðîñòðàíåííîñòè ïðîáëåìà â îòíîøåíèè ðàçäåëà «Àíîìàëüíàÿ òîêñè÷íîñòü» — åãîíåîáîñíîâàííîå èñêëþ÷åíèå èç ÍÄ. Íåñìîòðÿ íà òî, ÷òî áðàê ïî ïîêàçàòåëþ «Àíîìàëüíàÿ òîêñè÷íîñòü» íà ñòàäèè ýêñïåðòèçû âûÿâëÿåòñÿäîñòàòî÷íîðåäêî,ïðèìåðíî2–3 ñåðèèËÏâãîä, â ñâåòå ñíèæåíèÿ ÷èñëà ËÑ, êîíòðîëèðóåìûõ ïî äàííîìó ïîêàçàòåëþ, â åâðîïåéñêèõ ñòðàíàõ è ÑØÀ ðåãóëÿðíî âîçíèêàþò ñîîáùåíèÿ î íåæåëàòåëüíûõ ïî

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    òîêñè÷íîñòü» íà ñòàäèè ýêñïåðòèçû âûÿâëÿåòñÿäîñòàòî÷íîðåäêî,ïðèìåðíî2–3 ñåðèèËÏâãîä, â ñâåòå ñíèæåíèÿ ÷èñëà ËÑ, êîíòðîëèðóåìûõ ïî äàííîìó ïîêàçàòåëþ, â åâðîïåéñêèõ ñòðàíàõ è ÑØÀ ðåãóëÿðíî âîçíèêàþò ñîîáùåíèÿ î íåæåëàòåëüíûõ ïîñëåäñòâèÿõ ïðè ïðèìåíåíèè ËÏ. Òîëüêî â ÅÑ îò íåæåëàòåëüíûõ ïîñëåäñòâèé ïðè ïðèåìå ìåäèöèíñêèõ ïðåïàðàòîâ åæåãîäíî óìèðàþò 197 òûñ. ÷åë., ïîòåðè ñîñòàâëÿþò79 ìëðäåâðî
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    [13]
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    .Ñðåäèïîäîáíûõñëó÷àåâ íàèáîëüøèé ðåçîíàíñ ïîëó÷èëè ñêàíäàëû âîêðóã òàêèõ íåêà÷åñòâåííûõ ËÏ, êàê: L-òðèïòîôàí (Showa Denko,1989),Vioxx(Merck,2004),ìåòèëïðåäíèçîëîí àöåòàò (New England Compounding Center, 2012), âàêöèíà îò ãåïàòèòà  (BioKangtai, 2013), êîòîðûå ïðèâåëè ê ãèáåëè äåñÿòêîâ ïàöèåíòîâ è âûïëàòå êîëîññàëüíûõ êîìïåíñàöèé [14, 15].

14
Sharoykina MV, Ryabtseva MS, Kovaleva EL, Neugodova NP. Effect of parameter «Injection rate» during the test «Abnormal Toxicity» to ensure the quality of the antibiotic cephalosporin group — ceftriaxone. Antibiotiki i himioterapiya 2015; (1–2): 35–8 (in Russian).
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    åæåãîäíî óìèðàþò 197 òûñ. ÷åë., ïîòåðè ñîñòàâëÿþò79 ìëðäåâðî[13].Ñðåäèïîäîáíûõñëó÷àåâ íàèáîëüøèé ðåçîíàíñ ïîëó÷èëè ñêàíäàëû âîêðóã òàêèõ íåêà÷åñòâåííûõ ËÏ, êàê: L-òðèïòîôàí (Showa Denko,1989),Vioxx(Merck,2004),ìåòèëïðåäíèçîëîí àöåòàò (New England Compounding Center, 2012), âàêöèíà îò ãåïàòèòà  (BioKangtai, 2013), êîòîðûå ïðèâåëè ê ãèáåëè äåñÿòêîâ ïàöèåíòîâ è âûïëàòå êîëîññàëüíûõ êîìïåíñàöèé
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    [14, 15]
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    . Âîçíèêíîâåíèå ïîäîáíûõ ñëó÷àåâ ÿâëÿåòñÿ ïîäòâåðæäåíèåì íåñïîñîáíîñòè ñóùåñòâóþùåãî êîìïëåêñà ìåð äëÿ âûÿâëåíèÿ òîêñè÷åñêèõ ïðèìåñåé (âêëþ÷àÿ ðàñøèðåííóþ õàðàêòåðèñòèêó ïðîäóêòà, ñîáëþäåíèå ïðèíöèïîâ GMP, à òàêæå êîíòðîëü êà÷åñòâà òîëüêî ñ èñïîëüçîâàíèåì ôèçèêî-õèìè÷åñêèõ ìåòîäîâ) îáåñïå÷èòü áåçîïàñíîñòü ôàðìàöåâòè÷åñêîãî ïðîäóêòà äëÿ ïîòðåáèòåëÿ [16].

15
Karkischenko NN, Grachev SV. Guide to laboratory animals and alternative models in biomedical research. Moscow: Profile–2C; 2010 (in Russian).
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    åæåãîäíî óìèðàþò 197 òûñ. ÷åë., ïîòåðè ñîñòàâëÿþò79 ìëðäåâðî[13].Ñðåäèïîäîáíûõñëó÷àåâ íàèáîëüøèé ðåçîíàíñ ïîëó÷èëè ñêàíäàëû âîêðóã òàêèõ íåêà÷åñòâåííûõ ËÏ, êàê: L-òðèïòîôàí (Showa Denko,1989),Vioxx(Merck,2004),ìåòèëïðåäíèçîëîí àöåòàò (New England Compounding Center, 2012), âàêöèíà îò ãåïàòèòà  (BioKangtai, 2013), êîòîðûå ïðèâåëè ê ãèáåëè äåñÿòêîâ ïàöèåíòîâ è âûïëàòå êîëîññàëüíûõ êîìïåíñàöèé
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    [14, 15]
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    . Âîçíèêíîâåíèå ïîäîáíûõ ñëó÷àåâ ÿâëÿåòñÿ ïîäòâåðæäåíèåì íåñïîñîáíîñòè ñóùåñòâóþùåãî êîìïëåêñà ìåð äëÿ âûÿâëåíèÿ òîêñè÷åñêèõ ïðèìåñåé (âêëþ÷àÿ ðàñøèðåííóþ õàðàêòåðèñòèêó ïðîäóêòà, ñîáëþäåíèå ïðèíöèïîâ GMP, à òàêæå êîíòðîëü êà÷åñòâà òîëüêî ñ èñïîëüçîâàíèåì ôèçèêî-õèìè÷åñêèõ ìåòîäîâ) îáåñïå÷èòü áåçîïàñíîñòü ôàðìàöåâòè÷åñêîãî ïðîäóêòà äëÿ ïîòðåáèòåëÿ [16].

16
The Triptofan Incident. European Federation of Biotechnology. Fact Sheet 1. Available from: http:// www.quackwatch.com/01QuackeryRelatedTopics/DSH/trypto.html.
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    Âîçíèêíîâåíèå ïîäîáíûõ ñëó÷àåâ ÿâëÿåòñÿ ïîäòâåðæäåíèåì íåñïîñîáíîñòè ñóùåñòâóþùåãî êîìïëåêñà ìåð äëÿ âûÿâëåíèÿ òîêñè÷åñêèõ ïðèìåñåé (âêëþ÷àÿ ðàñøèðåííóþ õàðàêòåðèñòèêó ïðîäóêòà, ñîáëþäåíèå ïðèíöèïîâ GMP, à òàêæå êîíòðîëü êà÷åñòâà òîëüêî ñ èñïîëüçîâàíèåì ôèçèêî-õèìè÷åñêèõ ìåòîäîâ) îáåñïå÷èòü áåçîïàñíîñòü ôàðìàöåâòè÷åñêîãî ïðîäóêòà äëÿ ïîòðåáèòåëÿ
    Exact
    [16]
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    . Íà ýòîì ôîíå áèîëîãè÷åñêèå òåñòû ÿâëÿþòñÿ áîëåå óíèâåðñàëüíûìè [17].  îòëè÷èå îò áîëüøèíñòâà ôèçè÷åñêèõ è õèìè÷åñêèõ ìåòîäîâ, ñïåöèôè÷íîñòü òåñòà «Àíîìàëüíàÿ òîêñè÷íîñòü» ïîçâîëÿåò âûÿâèòü òîêñè÷íîñòü ËÑ, ïðåâûøàþùóþ óñòàíîâëåííûé ðàíåå óðîâåíü, à íå êîíêðåòíóþ ïðèìåñü èëè ðîäñòâåííîå ñîåäèíåíèå.

17
U. S. Food and Drug Administration. Available from: http://www.fda. gov/default.htm.
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    ñëó÷àåâ ÿâëÿåòñÿ ïîäòâåðæäåíèåì íåñïîñîáíîñòè ñóùåñòâóþùåãî êîìïëåêñà ìåð äëÿ âûÿâëåíèÿ òîêñè÷åñêèõ ïðèìåñåé (âêëþ÷àÿ ðàñøèðåííóþ õàðàêòåðèñòèêó ïðîäóêòà, ñîáëþäåíèå ïðèíöèïîâ GMP, à òàêæå êîíòðîëü êà÷åñòâà òîëüêî ñ èñïîëüçîâàíèåì ôèçèêî-õèìè÷åñêèõ ìåòîäîâ) îáåñïå÷èòü áåçîïàñíîñòü ôàðìàöåâòè÷åñêîãî ïðîäóêòà äëÿ ïîòðåáèòåëÿ [16]. Íà ýòîì ôîíå áèîëîãè÷åñêèå òåñòû ÿâëÿþòñÿ áîëåå óíèâåðñàëüíûìè
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    .  îòëè÷èå îò áîëüøèíñòâà ôèçè÷åñêèõ è õèìè÷åñêèõ ìåòîäîâ, ñïåöèôè÷íîñòü òåñòà «Àíîìàëüíàÿ òîêñè÷íîñòü» ïîçâîëÿåò âûÿâèòü òîêñè÷íîñòü ËÑ, ïðåâûøàþùóþ óñòàíîâëåííûé ðàíåå óðîâåíü, à íå êîíêðåòíóþ ïðèìåñü èëè ðîäñòâåííîå ñîåäèíåíèå.

18
Garbe YHO, Osborne C, Beggs K, Bopst M, Jos A, Kitashova AA, et al. Exclusion of test for abnormal toxicity as a quality control test: a historical analysis of the data and scientific knowledge. Razrabotka i registratsiya lekarstvennyh sredstv 2015;2(11): 184–92 (in Russian).
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    Òàê, íàïðèìåð, äëÿ ïðåïàðàòîâ öåôòðèàêñîí íàòðèÿ ñòàíäàðòíûìè óñëîâèÿìè âûïîëíåíèÿ òåñòà «Àíîìàëüíàÿ òîêñè÷íîñòü», îáåñïå÷èâàþùèìè íàäåæíûé óðîâåíü êîíòðîëÿ çà âîçíèêíîâåíèåì íåæåëàòåëüíûõ ïðèìåñåé, ÿâëÿþòñÿ: òåñò-äîçà 30 ìã íà ìûøü, âíóòðèâåííî, ñî ñêîðîñòüþ 0,1 ìë/ñ, ïåðèîä íàáëþäåíèÿ 48 ÷
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    [18]
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    . Îäíàêî íåäîáðîñîâåñòíûåïðîèçâîäèòåëèçà÷àñòóþñìÿã÷àþò óñëîâèÿ âûïîëíåíèÿ èñïûòàíèÿ, èçìåíÿÿ òðåáîâàíèÿ ðàçäåëà «Àíîìàëüíàÿ òîêñè÷íîñòü», à èìåííî — ñíèæàÿ ñêîðîñòü ââåäåíèÿ äî 0,1 ìë çà 3–6 ñ, èëè óìåíüøàÿ òåñò-äîçó.

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     òî æå âðåìÿ íå îòðèöàåòñÿ è îáùåìèðîâàÿ òåíäåíöèÿ ê èíäèâèäóàëüíîìó ïîäõîäó îöåíêè áåçîïàñíîñòè ËÑ ñ èñïîëüçîâàíèåì àëüòåðíàòèâíûõ ìåòîäîâ êîíòðîëÿ, êîòîðûå äîëæíû áûòü ñïåöèôè÷íû, ÷óâñòâèòåëüíû è îòðàáîòàíû íà ñòàäèè äîêëèíè÷åñêèõ èññëåäîâàíèé. «Íåîáõîäèìî ïðÿìîå ñðàâíåíèåáåçîïàñíîñòèëåêàðñòââòåñòàõíàæèâîòíûõñáàòàðåÿìè òåñòîâ, îñíîâàííûõ íà áèîëîãè÷åñêèõ îñíîâàõ ÷åëîâåêà»
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    . ËÈÒÅÐÀÒÓÐÀ 1. Ñåâåðöåâ ÂÀ, Ìàøêîâñêèé ÌÄ, Áàãèðîâà ÂË. è äð. Ìåòîäè÷åñêèå ðåêîìåíäàöèè ïî ââåäåíèþ ðàçäåëà «Èñïûòàíèå íà ïèðîãåííîñòü» â ÍÒÄ äëÿ âíîâü ðàçðàáàòûâàåìûõ èíúåêöèîííûõ ëåêàðñòâåííûõ ñðåäñòâ, à òàêæå âîäû è äðóãèõ æèäêîñòåé, èñïîëüçóåìûõ ïðè èõ èçãîòîâëåíèè, è èçäåëèé, ñ êîòîðûìè ñîïðèêàñàþòñÿ èëè â êîòîðûõ ñîäåðæàòñÿ ðàñòâîðû äëÿ èíúåêöèé.