The 13 references with contexts in paper G. Engalycheva N., R. Syubaev D., D. Goryachev V., Г. Енгалычева Н., Р. Сюбаев Д., Д. Горячев В. (2018) “Исследования фармакологической безопасности лекарственных средств: экспертная оценка полученных результатов // Safety Pharmacology Studies of Medicinal Products: Evaluation of Results” / spz:neicon:vedomostincesmp:y:2017:i:2:p:92-97

1
Guidance on evaluation of medicines. V. I. Moscow: Grif i K;2013 (in Russian).
Total in-text references: 3
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     íàñòîÿùåå âðåìÿ ôàðìàêîëîãè÷åñêèå èññëåäîâàíèÿ ïðèíÿòî ïîäðàçäåëÿòü íà òðè êàòåãîðèè: ïåðâè÷íûå ôàðìàêîäèíàìè÷åñêèå èññëåäîâàíèÿ, âòîðè÷íûå ôàðìàêîäèíàìè÷åñêèå èññëåäîâàíèÿ è èçó÷åíèå ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè
    Exact
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    . Èññëåäîâàíèÿ ïåðâè÷íîé ôàðìàêîäèíàìèêè — ýòî èçó÷åíèå ìåõàíèçìà äåéñòâèÿ è ýôôåêòîâ äåéñòâóþùåãî âåùåñòâà â îòíîøåíèè åãî öåëåâîé òåðàïåâòè÷åñêîé ìèøåíè. Âòîðè÷íûå ôàðìàêîäèíàìè÷åñêèå èññëåäîâàíèÿ — ýòî èçó÷åíèå ìåõàíèçìà äåéñòâèÿ è ýôôåêòîâ âåùåñòâà, íå ñâÿçàííûõ ñ åãî öåëåâîé òåðàïåâòè÷åñêîé ìèøåíüþ.

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     2013 ãîäó Ôåäåðàëüíîå ãîñóäàðñòâåííîå áþäæåòíîå ó÷ðåæäåíèå «Íàó÷íûé öåíòð ýêñïåðòèçû ñðåäñòâ ìåäèöèíñêîãî ïðèìåíåíèÿ »Ìèíèñòåðñòâà çäðàâîîõðàíåíèÿ Ðîññèéñêîé Ôåäåðàöèè èçäàëî ìåòîäè÷åñêèå ðåêîìåíäàöèè ïî èçó÷åíèþ ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè ëåêàðñòâåííûõ ñðåäñòâ
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    , â 2016 ãîäó ââåäåí â äåéñòâèå ÃÎÑÒ Ð 56700–2015, ïîñâÿùåííûé äîêëèíè÷åñêèì èññëåäîâàíèÿì ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè [8].  ðàìêàõ ðåãóëèðîâàíèÿ îáðàùåíèÿ ëåêàðñòâåííûõ ñðåäñòâ Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà â 2016 ãîäó óòâåðæäåíû Ïðàâèëà ðåãèñòðàöèè è ýêñïåðòèçû ëåêàðñòâåííûõ ñðåäñòâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ, êîòîðûå ðåãëàìåíòèðóþò òàêæå è òðåáîâàíèÿ ê ýêñïåðòíîé îöåíêå

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     ïåðâóþ î÷åðåäü íåîáõîäèìî èçó÷èòü âëèÿíèå ïðåïàðàòà íà æèçíåííî âàæíûå ñèñòåìû îðãàíèçìà: ñåðäå÷íî-ñîñóäèñòóþ, äûõàòåëüíóþ è öåíòðàëüíóþ íåðâíóþ. Ýòî òàê íàçûâàåìàÿ «Îñíîâíàÿ áàòàðåÿ òåñòîâ», êîòîðàÿ, ñîãëàñíî ñîâðåìåííûì òðåáîâàíèÿì, äîëæíà áûòü ïðîâåäåíà äî ïåðâîãî ïðèìåíåíèÿ ïðåïàðàòà ó ÷åëîâåêà
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    . Ïðè âûÿâëåíèè êàêèõ-ëèáî íåãàòèâíûõ ôàêòîâ ïðîâîäÿò ïîñëåäóþùèå (óòî÷íÿþùèå) èññëåäîâàíèÿ ñ öåëüþ óãëóáëåííîãî èçó÷åíèÿ äàííûõ ýôôåêòîâ (òàáë. 2). Èçó÷åíèå âëèÿíèÿ ïðåïàðàòà íà öåíòðàëüíóþ íåðâíóþ ñèñòåìó â ðàìêàõ ïðîâåäåíèÿ îñíîâíîé áàÒàáëèöà 1 ÂÈÄÛ ÈÑÑËÅÄÎÂÀÍÈÉ ÔÀÐÌÀÊÎËÎÃÈ×ÅÑÊÎÉ ÁÅÇÎÏÀÑÍÎÑÒÈ Âèä èññëåäîâàíèÿÎñíîâíûå çàäà÷è Îáÿçàòåëüíûå («Îñíîâíàÿ áàòàðåÿ òåñòîâ») Èçó÷åíèå âëèÿíèÿ íà æèçíåííî â

2
Federal Law of the Russian Federation of 12.04.2010, No. 61-FZ «On Circulation of Medicines». Available from: https://goo.gl/ 5KYWwR (in Russian).
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    Ãîñóäàðñòâåííàÿ ðåãèñòðàöèÿ ëåêàðñòâåííûõ ïðåïàðàòîâ â Ðîññèè îñóùåñòâëÿåòñÿ íà îñíîâàíèè Ôåäåðàëüíîãî çàêîíà Ðîññèéñêîé Ôåäåðàöèè îò 12 àïðåëÿ 2010 ã. ¹ 61-ÔÇ «Îá îáðàùåíèè ëåêàðñòâåííûõ ñðåäñòâ »
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    . Ðåãèñòðàöèÿ îñóùåñòâëÿåòñÿ ïî ðåçóëüòàòàì ýêñïåðòèçû êà÷åñòâà ëåêàðñòâåííîãî ïðåïàðàòà äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ è ýêñïåðòèçû îòíîøåíèÿ îæèäàåìîé ïîëüçû ê âîçìîæíîìó ðèñêó ïðèìåíåíèÿ ëåêàðñòâåííîãî ïðåïàðàòà [3, 4].

3
Order of the Ministry of Health and Social Development of the Russian Federation of 26.08.2010, No. 750n «On approval of rules of expert evaluation of medicinal products for human use, and of the expert commission opinion form». Available from: https://goo.gl/ wz7nMH (in Russian).
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    Ðåãèñòðàöèÿ îñóùåñòâëÿåòñÿ ïî ðåçóëüòàòàì ýêñïåðòèçû êà÷åñòâà ëåêàðñòâåííîãî ïðåïàðàòà äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ è ýêñïåðòèçû îòíîøåíèÿ îæèäàåìîé ïîëüçû ê âîçìîæíîìó ðèñêó ïðèìåíåíèÿ ëåêàðñòâåííîãî ïðåïàðàòà
    Exact
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    .  ðàìêàõ ôîðìèðîâàíèÿ åäèíîé íîðìàòèâíî-ïðàâîâîé áàçû Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà â ñôåðå ëåêàðñòâåííîãî îáðàùåíèÿ, âîïðîñû ýêñïåðòíûõ ïîäõîäîâ ê îöåíêå ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè ëåêàðñòâåííûõ ïðåïàðàòîâ ïðèîáðåòàþò àêòóàëüíîå çíà÷åíèå.

4
Order of the Ministry of Health of the Russian Federation of 13.12.2012, No. 1041n «On amendments to the Order of the Ministry of Health and Social Development of the Russian Federation of 26.08.2010, No. 750n «On approval of rules of expert evaluation of medicinal products for human use, and of the expert commission opinion form». Available from: https://goo.gl/Dt7EBm (in Russian).
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    Ðåãèñòðàöèÿ îñóùåñòâëÿåòñÿ ïî ðåçóëüòàòàì ýêñïåðòèçû êà÷åñòâà ëåêàðñòâåííîãî ïðåïàðàòà äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ è ýêñïåðòèçû îòíîøåíèÿ îæèäàåìîé ïîëüçû ê âîçìîæíîìó ðèñêó ïðèìåíåíèÿ ëåêàðñòâåííîãî ïðåïàðàòà
    Exact
    [3, 4]
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    .  ðàìêàõ ôîðìèðîâàíèÿ åäèíîé íîðìàòèâíî-ïðàâîâîé áàçû Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà â ñôåðå ëåêàðñòâåííîãî îáðàùåíèÿ, âîïðîñû ýêñïåðòíûõ ïîäõîäîâ ê îöåíêå ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè ëåêàðñòâåííûõ ïðåïàðàòîâ ïðèîáðåòàþò àêòóàëüíîå çíà÷åíèå.

5
Safety Pharmacology Studies for Human Pharmaceuticals (S7A) 2000. Available from: https:// goo.gl/h2dG2M.
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     íîÿáðå 2000 ãîäà áûëî óòâåðæäåíî Ðóêîâîäñòâî ICH S7A, ïîñâÿùåííîå îáùèì ïðèíöèïàì ïðîâåäåíèÿ èññëåäîâàíèé ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè, à â 2005 ãîäó (Ðóêîâîäñòâî ICH S7B, ïîñâÿùåííîå èçó÷åíèþ ïîòåíöèàëüíûõ êàðäèîòîêñè÷åñêèõýôôåêòîâëåêàðñòâåííûõ ñðåäñòâ
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    . Ñ ìîìåíòà ïðèíÿòèÿ Ðóêîâîäñòâà S7A ôàðìàêîëîãè÷åñêàÿ áåçîïàñíîñòü ñòðåìèòåëüíî ðàçâèâàåòñÿ óæå êàê ñàìîñòîÿòåëüíàÿ äèñöèïëèíà, êîòîðàÿ îáúåäèíÿåò ýêñïåðèìåíòàëüíóþ ôàðìàêîëîãèþ, ôèçèîëîãèþ è ëåêàðñòâåííóþ òîêñèêîëîãèþ.

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Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (S7B) 2005. Available from: https:// goo.gl/5W0wSG.
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     íîÿáðå 2000 ãîäà áûëî óòâåðæäåíî Ðóêîâîäñòâî ICH S7A, ïîñâÿùåííîå îáùèì ïðèíöèïàì ïðîâåäåíèÿ èññëåäîâàíèé ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè, à â 2005 ãîäó (Ðóêîâîäñòâî ICH S7B, ïîñâÿùåííîå èçó÷åíèþ ïîòåíöèàëüíûõ êàðäèîòîêñè÷åñêèõýôôåêòîâëåêàðñòâåííûõ ñðåäñòâ
    Exact
    [5, 6]
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    . Ñ ìîìåíòà ïðèíÿòèÿ Ðóêîâîäñòâà S7A ôàðìàêîëîãè÷åñêàÿ áåçîïàñíîñòü ñòðåìèòåëüíî ðàçâèâàåòñÿ óæå êàê ñàìîñòîÿòåëüíàÿ äèñöèïëèíà, êîòîðàÿ îáúåäèíÿåò ýêñïåðèìåíòàëüíóþ ôàðìàêîëîãèþ, ôèçèîëîãèþ è ëåêàðñòâåííóþ òîêñèêîëîãèþ.

7
What is Safety Pharmacology? Available from: https:// goo.gl/etRTwe.
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    Ñ ìîìåíòà ïðèíÿòèÿ Ðóêîâîäñòâà S7A ôàðìàêîëîãè÷åñêàÿ áåçîïàñíîñòü ñòðåìèòåëüíî ðàçâèâàåòñÿ óæå êàê ñàìîñòîÿòåëüíàÿ äèñöèïëèíà, êîòîðàÿ îáúåäèíÿåò ýêñïåðèìåíòàëüíóþ ôàðìàêîëîãèþ, ôèçèîëîãèþ è ëåêàðñòâåííóþ òîêñèêîëîãèþ.  2001 ãîäó ñîçäàíî ìåæäóíàðîäíîå Îáùåñòâî ïî ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè — Safety Pharmacology Society
    Exact
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    .  2013 ãîäó Ôåäåðàëüíîå ãîñóäàðñòâåííîå áþäæåòíîå ó÷ðåæäåíèå «Íàó÷íûé öåíòð ýêñïåðòèçû ñðåäñòâ ìåäèöèíñêîãî ïðèìåíåíèÿ »Ìèíèñòåðñòâà çäðàâîîõðàíåíèÿ Ðîññèéñêîé Ôåäåðàöèè èçäàëî ìåòîäè÷åñêèå ðåêîìåíäàöèè ïî èçó÷åíèþ ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè ëåêàðñòâåííûõ ñðåäñòâ [1], â 2016 ãîäó ââåäåí â äåéñòâèå ÃÎÑÒ Ð 56700–2015, ïîñâÿùåííûé äîêëèíè÷åñêèì èññëåäîâàíèÿì ôàðìàêîëîãè÷åñêîé áåçîïàñ

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State Standard R 56700 – 2015. Medicinal products for human use. Pre-clinical safety pharmacology studies. Moscow: Standartinform; 2016 (in Russian).
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    ãîäó Ôåäåðàëüíîå ãîñóäàðñòâåííîå áþäæåòíîå ó÷ðåæäåíèå «Íàó÷íûé öåíòð ýêñïåðòèçû ñðåäñòâ ìåäèöèíñêîãî ïðèìåíåíèÿ »Ìèíèñòåðñòâà çäðàâîîõðàíåíèÿ Ðîññèéñêîé Ôåäåðàöèè èçäàëî ìåòîäè÷åñêèå ðåêîìåíäàöèè ïî èçó÷åíèþ ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè ëåêàðñòâåííûõ ñðåäñòâ [1], â 2016 ãîäó ââåäåí â äåéñòâèå ÃÎÑÒ Ð 56700–2015, ïîñâÿùåííûé äîêëèíè÷åñêèì èññëåäîâàíèÿì ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè
    Exact
    [8]
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    .  ðàìêàõ ðåãóëèðîâàíèÿ îáðàùåíèÿ ëåêàðñòâåííûõ ñðåäñòâ Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà â 2016 ãîäó óòâåðæäåíû Ïðàâèëà ðåãèñòðàöèè è ýêñïåðòèçû ëåêàðñòâåííûõ ñðåäñòâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ, êîòîðûå ðåãëàìåíòèðóþò òàêæå è òðåáîâàíèÿ ê ýêñïåðòíîé îöåíêå èññëåäîâàíèé ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè [9].

9
Decision of the Council of the Eurasian Economic Commission of 03.11.2016, No. 78 «On rules of registration and evaluation ofmedicinalproductsforhumanuse».Availablefrom: https://goo.gl/s9NsVS (in Russian).
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     ðàìêàõ ðåãóëèðîâàíèÿ îáðàùåíèÿ ëåêàðñòâåííûõ ñðåäñòâ Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà â 2016 ãîäó óòâåðæäåíû Ïðàâèëà ðåãèñòðàöèè è ýêñïåðòèçû ëåêàðñòâåííûõ ñðåäñòâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ, êîòîðûå ðåãëàìåíòèðóþò òàêæå è òðåáîâàíèÿ ê ýêñïåðòíîé îöåíêå èññëåäîâàíèé ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè
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    . Ðåñïóáëèêà Êàçàõñòàí â III êâàðòàëå 2017 ãîäà ïðåäñòàâèò ïðîåêò Ðóêîâîäñòâà ïî èññëåäîâàíèþ ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè ëåêàðñòâåííûõ ïðåïàðàòîâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ. ÎÁÙÈÅ ÒÐÅÁÎÂÀÍÈß Ê ÏÐÎÂÅÄÅÍÈÞ ÈÑÑËÅÄÎÂÀÍÈÉ ÔÀÐÌÀÊÎËÎÃÈ×ÅÑÊÎÉ ÁÅÇÎÏÀÑÍÎÑÒÈ Ñîãëàñíî ñîâðåìåííûì òðåáîâàíèÿì, èññëåäîâàíèÿ ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè ïðîâîäÿòñÿ ñ öåëüþ: lâûÿâëåíèÿ íåæåëàòåëüíûõ ôàðìàêîäèíàìè÷åñêèõ ýôô

10
Engalycheva GN, Syubaev RD, Vasiliev AN. Interpretation of class-specific effects in preclinical safety studies of drugs. Sechenovsky vestnik 2016; 2(24): 11–2 (in Russian).
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    Îòñóòñòâèå äåòàëüíîãî àíàëèçà êëàññ-ñïåöèôè÷åñêèõ ñâîéñòâ ïðè èíòåðïðåòàöèè ðåçóëüòàòîâ äîêëèíè÷åñêèõ èññëåäîâàíèé îðèãèíàëüíîãî ëåêàðñòâåííîãî ñðåäñòâà íå ïîçâîëÿåò ïîëó÷èòü êîððåêòíóþ ôàðìàêîòîêñèêîëîãè÷åñêóþ õàðàêòåðèñòèêó ðèñêà
    Exact
    [10]
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    . Ïîäëåæèò îöåíêå ÷óâñòâèòåëüíîñòü òåñò-ñèñòåìû, åå àäåêâàòíîñòü. Äëÿ îáåñïå÷åíèÿ âîñïðîèçâîäèìîñòè ðåçóëüòàòîâ ìîäåëü äîëæíà áûòü ñòàíäàðòèçîâàíà. Ïðè èñïîëüçîâàíèè æèâîòíûõ ðàçðàáîò÷èê äîëæåí îáîñíîâàòü âèä (åãî ðåëåâàíòíîñòü), ïîë, âîçðàñò, ôàðìàêîäèíàìè÷åñêèé îòâåò, ôàðìàêîêèíåòè÷åñêèå ïàðàìåòðû.

11
Engalycheva GN, Syubaev RD, Vasiliev AN. Modern requirements to preclinical studies of narcological safety of neurotropic drugs. Obozrenie psihiatrii i meditsinskoy psihologii 2014; Suppl.: 74–5 (in Russian).
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    Íàïðèìåð, ïðè ðàçðàáîòêå ïðåïàðàòà äëÿ òåðàïèè áîëåçíè Êðîíà íåîáõîäèìî îöåíèòü åãî âëèÿíèå íà ïèùåâàðèòåëüíûé òðàêò, ïðè ðàçðàáîòêå ïðåïàðàòà äëÿ òåðàïèè ïåðâè÷íîé ãèïåðòåíçèè — íà ôóíêöèþ ïî÷åê è ò.ä. Èçó÷åíèå ïîòåíöèàëà ðàçâèòèÿ ëåêàðñòâåííîé çàâèñèìîñòè ÿâëÿåòñÿ îáÿçàòåëüíûì äëÿ âñåõ ïðåïàðàòîâ íåéðîòðîïíîãî äåéñòâèÿ èëè èìåþùèõ ñòðóêòóðíîå ñõîäñòâî ñ ïñèõîòðîïíûìè ïðåïàðàòàìè
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    . Ïðè ýêñïåðòèçå ó÷èòûâàþò ñòàäèþ êëèíè÷åñêîé ðàçðàáîòêè ïðåïàðàòà. Åñëè ïðåäïîëàãàåòñÿ âïåðâûå ïðèìåíÿòü ïðåïàðàò ó ÷åëîâåêà, òî ðàçðàáîò÷èê îáÿçàí ïðåäñòàâèòü ðåçóëüòàòû èññëåäîâàíèé «Îñíîâíîé áàòàðåè òåñòîâ »ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè.

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Engalycheva GN, Syubaev RD, Vasiliev AN, Snegireva AA, Verstakova OL. Preclinical safety pharmacology evaluation of medicinal products The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2013; (1): 10–3 (in Russian).
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    Èññëåäîâàíèÿ ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè èìåþò ïðèíöèïèàëüíîå çíà÷åíèå äëÿ ïðîãíîçèðîâàíèÿ ðèñêà êðèòè÷íûõ èçìåíåíèé ôèçèîëîãè÷åñêèõ ôóíêöèé îðãàíèçìà, èõ íåäîñòàòî÷íîñòü ìîæåò ïðèâîäèòü ê ðåäóöèðîâàííîé îöåíêå âàæíûõ ôóíêöèîíàëüíûõ ïàðàìåòðîâ
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    . Îòñóòñòâèå êàêèõ-ëèáî âèäîâ èññëåäîâàíèé ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè äîëæíî áûòü íàó÷íî îáîñíîâàíî ðàçðàáîò÷èêîì. Ïîëíîöåííàÿ õàðàêòåðèñòèêà ïðîôèëÿ òîêñè÷íîñòè ëåêàðñòâåííîãî ñðåäñòâà, âêëþ÷àþùàÿ ðåçóëüòàòû äîêëèíè÷åñêîãî èññëåäîâàíèÿ ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè, òðåáóåòñÿ íå òîëüêî äëÿ îöåíêè ðèñêà êëàññ-ñïåöèôè÷åñêèõ ýôôåêòîâ íà ýòàïå êëèíè÷åñêîé ðàçðàáîòêè ïðåïàðàòà, íî òàêæå è äëÿ àíà

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Romanov BK, Alyautdin RN, Glagolev SV, Polivanov VA. Typical pharmacovigilance system master file (PSMF). Safety and Risk of Pharmacotherapy 2016; (2): 11–27 (in Russian). AUTHORS Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health
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    Ïîëíîöåííàÿ õàðàêòåðèñòèêà ïðîôèëÿ òîêñè÷íîñòè ëåêàðñòâåííîãî ñðåäñòâà, âêëþ÷àþùàÿ ðåçóëüòàòû äîêëèíè÷åñêîãî èññëåäîâàíèÿ ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè, òðåáóåòñÿ íå òîëüêî äëÿ îöåíêè ðèñêà êëàññ-ñïåöèôè÷åñêèõ ýôôåêòîâ íà ýòàïå êëèíè÷åñêîé ðàçðàáîòêè ïðåïàðàòà, íî òàêæå è äëÿ àíàëèçà ïðîèñõîæäåíèÿ íåæåëàòåëüíûõ ðåàêöèé, ðåãèñòðèðóåìûõ ñèñòåìîé ôàðìàêîíàäçîðà ïðè åãî ìåäèöèíñêîì ïðèìåíåíèè
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    . ÇÀÊËÞ×ÅÍÈÅ Èññëåäîâàíèÿ ôàðìàêîëîãè÷åñêîé áåçîïàñíîñòè ÿâëÿþòñÿ íåîòúåìëåìîé ÷àñòüþ èçó÷åíèÿ áåçîïàñíîñòè íîâûõ ëåêàðñòâåííûõ ïðåïàðàòîâ. Îáÿçàòåëüíîìó èçó÷åíèþ ïîäëåæèò âëèÿíèå ïðåïàðàòà íà ôóíêöèþ ñåðäå÷íî-ñîñóäèñòîé, öåíòðàëüíîé íåðâíîé è äûõàòåëüíîé ñèñòåì.