The 18 references with contexts in paper N. Eremenko N., D. Goryachev V., E. Shikh V., Н. Еременко Н., Д. Горячев В., Е. Ших В. (2018) “Оценка фармакокинетики эндогенных соединений на примере препаратов кальция // Evaluation of endogenous compounds pharmacokinetics as illustrated by calcium” / spz:neicon:vedomostincesmp:y:2017:i:2:p:104-110

1
Adonin VK, Romodanovskiy DP, Niyazov RR. Specific features of the bioequivalence study of drugs — analogs of endogenous compounds. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2015; (3): 3–8 (in Russian).
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    Ýíäîãåííûå ñîåäèíåíèÿ — ýòî ñîåäèíåíèÿ, êîòîðûå âûðàáàòûâàþòñÿ êëåòêàìè îðãàíèçìà ÷åëîâåêà âñëåäñòâèå ïðîòåêàþùèõ â íåì ôèçèîëîãè÷åñêèõ è (èëè) ïàòîëîãè÷åñêèõ ïðîöåññîâ è êîòîðûå, êàê ïðàâèëî, ÿâëÿþòñÿ áèîëîãè÷åñêè àêòèâíûìè âåùåñòâàìè, ó÷àñòâóþùèìè â ðàçëè÷íûõ ìåòàáîëè÷åñêèõ ïðîöåññàõ îðãàíèçìà
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    . Äëÿ îöåíêè ôàðìàêîêèíåòèêè, îòíîñèòåëüíîé áèîäîñòóïíîñòè è áèîýêâèâàëåíòíîñòè ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé, íåîáõîäèìî ó÷èòûâàòü ïðèðîäó êàæäîãî îòäåëüíîãî ýíäîãåííîãî âåùåñòâà, ìåõàíèçìû ðåãóëÿöèè åãî ãîìåîñòàçà, à òàêæå òî, ÷òî â îðãàíèçìå óêàçàííûå ñîåäèíåíèÿ âñåãäà ïðèñóòñòâóþò â ôîíîâûõ ýíäîãåííûõ êîíöåíòðàöèÿõ.

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     îòíîøåíèè ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé — â íàñòîÿùåå âðåìÿ â Ðîññèéñêîé Ôåäåðàöèè îòñóòñòâóþò íîðìàòèâíî-ïðàâîâûå àêòû, êîòîðûå ðåãóëèðóþò ïðàâèëà ïðîâåäåíèÿ ôàðìàêîêèíåòè÷åñêèõ èññëåäîâàíèéin vivoäëÿ êîíêðåòíûõ ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé
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    . Ïðè èçó÷åíèè ôàðìàêîêèíåòèêè ËÏ, ñîäåðæàùèõ â ñâîåì ñîñòàâå ðàçëè÷íûå ñîëè êàëüöèÿ, ñëåäóåò ðóêîâîäñòâîâàòüñÿ èìåþùåéñÿ íàó÷íîé ëèòåðàòóðîé, îïûòîì ïðîâåäåíèÿ ïîäîáíûõ êëèíè÷åñêèõ èññëåäîâàíèé, êîìïëåêñíî îöåíèâàÿ ïàðàìåòðû ôàðìàêîêèíåòèêè, ãîìåîñòàòè÷åñêèå ìåõàíèçìû, ðåãóëèðóþùèå êîíöåíòðàöèþ êàëüöèÿ, è åãî ãîðìîíàëüíóþ ðåãóëÿöèþ — ïàðàòèðåîèäíûé ãîðìîí.

2
State Register of medicines. Available from: http://grls.rosminzdrav.ru/ (in Russian).
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    Öåëü ðàáîòû— ñðàâíèòåëüíûé àíàëèç ïîäõîäîâ ê îöåíêå ôàðìàêîêèíåòèêè ýíäîãåííûõ ñîåäèíåíèé íà ïðèìåðå ïðåïàðàòîâ êàëüöèÿ. ÌÀÒÅÐÈÀËÛ È ÌÅÒÎÄÛ Â íàñòîÿùåå âðåìÿ â Ðîññèéñêîé Ôåäåðàöèè çàðåãèñòðèðîâàíû ËÏ ðàçëè÷íûõ ñîëåé êàëüöèÿ â ðàçíîîáðàçíûõ ëåêàðñòâåííûõ ôîðìàõ (òàáë. 1)
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    . Ïî äàííûì ÂÎÇ [3], ïðåïàðàòû êàëüöèÿ èìåþò êîä ÀÒÕ (àíàòîìî-òåðàïåâòè÷åñêè-õèìè÷åñêàÿ êëàññèôèêàöèÿ) À12À (òàáë. 2). Ñ ó÷åòîì èíòåðåñà ê ËÏ êàëüöèÿ, îáóñëîâëåííûì áîëüøèì ñïåêòðîì çàáîëåâàíèé, ñâÿçàííûõ ñ íàðóøåíèåì îáìåíà êàëüöèÿ â îðãàíèçìå, íåîáõîäèìî âûðàáîòàòü åäèíûå ïîäõîäû ê ïðîâåäåíèþ è îöåíêå ðåçóëüòàòîâ èçó÷åíèÿ ñðàâíèòåëüíîé ôàðìàêîêèíåòèêè ËÏ, ñîäåðæàùèõ â ñâîåì ñîñòàâå èîíû êàëüöèÿ

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    Ðèñ. 1.Âèäû áàçîâûõ ëèíèè êîíöåíòðàöèé ýíäîãåííûõ âåùåñòâ. «Íåïðåäñêàçóåìî íåñòàáèëüíàÿ áàçîâàÿ ëèíèÿ» Òàáëèöà 1 ÑÏÈÑÎÊ ÑÎËÅÉ ÊÀËÜÖÈß Â ÑÎÑÒÀÂÅ ËÅÊÀÐÑÒÂÅÍÍÛÕ ÏÐÅÏÀÐÀÒÎÂ, ÇÀÐÅÃÈÑÒÐÈÐÎÂÀÍÍÛÕ Â ÐÎÑÑÈÉÑÊÎÉ ÔÅÄÅÐÀÖÈÈ
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    Ñîëü êàëüöèÿÔîðìà âûïóñêà Êàëüöèÿ ãëþêîíàò (calcium gluconate) Ðàñòâîð äëÿ âíóòðèâåííîãî è âíóòðèìûøå÷íîãî ââåäåíèÿ. Òàáëåòêè. Òàáëåòêè øèïó÷èå. Òàáëåòêè æåâàòåëüíûå Êàëüöèÿ ãëèöåðîôîñôàò (calcium glycerylphosphate) Òàáëåòêè 200 ìã Êàëüöèÿ äîáåçèëàòÊàïñóëû 500 ìã Êàëüöèÿ êàðáîíàò (calcium carbonate) Òàáëåòêè øèïó÷èå 1,25 ã è 4,2 ã.

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    Òàêèì îáðàçîì, ïðè ïëàíèðîâàíèè ñðàâíèòåëüíûõ êëèíè÷åñêèõ èññëåäîâàíèé äëÿ èçó÷åíèÿ ôàðìàêîêèíåòèêè ËÏ, ñîäåðæàùèõ èîíû êàëüöèÿ, îñîáîå âíèìàíèå íåîáõîäèìî îáðàùàòü íà ñîëè êàëüöèÿ, êîòîðûå ñîäåðæàòñÿ â èçó÷àåìîì ïðåïàðàòå (òàáë. 1)
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    . Äëÿ êîìïëåêñíîé îöåíêè ôàðìàêîêèíåòèêè ËÏ, ñîäåðæàùèõ â ñâîåì ñîñòàâå ñîëè êàëüöèÿ, ïîìèìî îïðåäåëåíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè, íåîáõîäèìî ó÷èòûâàòü ñóùåñòâóþùèå ãîìåîñòàòè÷åñêèå ìåõàíèçìû, êîòîðûå ïîääåðæèâàþò óðîâåíü êàëüöèÿ â ïðåäåëàõ ôèçèîëîãè÷åñêîé íîðìû [15].

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ATC/DDD Index 2017. Available from: http://www.whocc.no/ atc_ddd_index/?code.
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    Öåëü ðàáîòû— ñðàâíèòåëüíûé àíàëèç ïîäõîäîâ ê îöåíêå ôàðìàêîêèíåòèêè ýíäîãåííûõ ñîåäèíåíèé íà ïðèìåðå ïðåïàðàòîâ êàëüöèÿ. ÌÀÒÅÐÈÀËÛ È ÌÅÒÎÄÛ Â íàñòîÿùåå âðåìÿ â Ðîññèéñêîé Ôåäåðàöèè çàðåãèñòðèðîâàíû ËÏ ðàçëè÷íûõ ñîëåé êàëüöèÿ â ðàçíîîáðàçíûõ ëåêàðñòâåííûõ ôîðìàõ (òàáë. 1) [2]. Ïî äàííûì ÂÎÇ
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    , ïðåïàðàòû êàëüöèÿ èìåþò êîä ÀÒÕ (àíàòîìî-òåðàïåâòè÷åñêè-õèìè÷åñêàÿ êëàññèôèêàöèÿ) À12À (òàáë. 2). Ñ ó÷åòîì èíòåðåñà ê ËÏ êàëüöèÿ, îáóñëîâëåííûì áîëüøèì ñïåêòðîì çàáîëåâàíèé, ñâÿçàííûõ ñ íàðóøåíèåì îáìåíà êàëüöèÿ â îðãàíèçìå, íåîáõîäèìî âûðàáîòàòü åäèíûå ïîäõîäû ê ïðîâåäåíèþ è îöåíêå ðåçóëüòàòîâ èçó÷åíèÿ ñðàâíèòåëüíîé ôàðìàêîêèíåòèêè ËÏ, ñîäåðæàùèõ â ñâîåì ñîñòàâå èîíû êàëüöèÿ â âèäå ðàçëè÷íûõ ñî

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    Ïîðîøîê äëÿ ïðèãîòîâëåíèÿ ñóñïåíçèè äëÿ ïðèåìà âíóòðü Êàëüöèÿ êàðáîíàò + êàëüöèÿ ëàêòîãëþêîíàò Òàáëåòêè øèïó÷èå Êàëüöèÿ ãëþêîíàò + Ìàôåíèä + Íàòðèÿ àëãèíàò + Ôåíîçàíîâàÿ êèñëîòà Ãóáêà Êàëüöèÿ ãëþêîíàò + Íàòðèÿ àëãèíàò + Íèòðîôóðàë Ãóáêà Òàáëèöà 2 ÊÎÄ ÀÒÕ ÏÐÅÏÀÐÀÒΠÊÀËÜÖÈß
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    Êîä ÀÒÕÍàçâàíèåÄîçà Ïóòü ââåäåíèÿ ÀÏèùåâàðèòåëüíûé òðàêò è ìåòàáîëèçì (ALIMENTARY TRACT AND METABOLISM) À12Ìèíåðàëüíûå äîáàâêè (MINERAL SUPPLEMENTS) À12ÀÊàëüöèé (CALCIUM) À12ÀÀÊàëüöèé (Calcium) A12AA01 calcium phosphate2 ãÎðàëüíûé A12AA02 calcium glubionate2,75 ãÏàðýíòåðàëüíûé A12AA03 calcium gluconate3 ãÎðàëüíûé/ ïàðýíòåðàëüíûé A12AA04 calcium carbonate3 ãÎðàëüíûé A12AA05 calcium lactate2

4
Colucci P, Pasternyk-Di Marco M, Potvinand D, Ducharme MP. Bioequivalence Assessment of Endogenous Drug Substances: Pharmacokinetics and Statistical Evaluation. In: Generic Drug Product Development: Bioequivalence; 2007. P. 233–56.
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    Ðàçëè÷àþò íåñêîëüêî âèäîâ ôîíîâûõ ëèíèé ýíäîãåííûõ êîíöåíòðàöèé. Äëÿ ïðåïàðàòîâ êàëüöèÿ õàðàêòåðåí òàê íàçûâàåìûé «íåïðåäñêàçóåìî íåñòàáèëüíûé »âèä áàçîâîé ëèíèè êîíöåíòðàöèé (ðèñ. 1) ýíäîãåííûõ âåùåñòâ
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    . Äàííûé âèä áàçîâîé ëèíèè ìîæåò íàáëþäàòüñÿ â äâóõ ñëó÷àÿõ: – ðåàãèðîâàíèå ïî òèïó «îáðàòíîé ñâÿçè »— îðãàíèçì ïûòàåòñÿ êîíòðîëèðîâàòü êîíöåíòðàöèè ýíäîãåííûõ âåùåñòâ è óìåíüøàåò ñèíòåç ýíäîãåííîãî âåùåñòâà â îòâåò íà ââåäåíèå ýêçîãåííîãî; – ñòàáèëèçàöèÿ êîíöåíòðàöèé âñëåäñòâèå ãîìåîñòàçà; ñóùåñòâóþùèå ãîìåîñòàòè÷åñêèå ìåõàíèçìû ïîääåðæàíèÿ óðîâíÿ íåêîòîðûõ ýíäîãåííûõ âåùåñòâ â ïðåäåëàõ ôèçèîë

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Kressel G, Wolters M, Hahn A. Bioavailability and Solubility of Different Calcium-Salts as a Basis for Calcium Enrichment of Beverages. Food and Nutrition Sciences 2010; (1): 53–8.
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    ýêçîãåííîãî; – ñòàáèëèçàöèÿ êîíöåíòðàöèé âñëåäñòâèå ãîìåîñòàçà; ñóùåñòâóþùèå ãîìåîñòàòè÷åñêèå ìåõàíèçìû ïîääåðæàíèÿ óðîâíÿ íåêîòîðûõ ýíäîãåííûõ âåùåñòâ â ïðåäåëàõ ôèçèîëîãè÷åñêîé íîðìû íå äîïóñêàþò èçìåíåíèÿ êîíöåíòðàöèè äî òîêñè÷íîãî óðîâíÿ. Ýòî óòâåðæäåíèå îòíîñèòñÿ ê ðÿäó èîíîâ (êàëèÿ, êàëüöèÿ, ìàãíèÿ, æåëåçà è àëþìèíèÿ), ãëþòàìèíó, L-êàðíèòèíó è íåêîòîðûì âèòàìèíàì (D2, D3 è Â12)
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    .  íåêîòîðûõ ñëó÷àÿõ ïðèìåíåíèå äàæå áîëüøîãî êîëè÷åñòâà ËÏ — àíàëîãà ýíäîãåííûõ ñîåäèíåíèé — íå èçìåíÿåò ãîìåîñòàòè÷åñêîãî ðàâíîâåñèÿ ýíäîãåííîãî âåùåñòâà è ïðèâîäèò ê íåçíà÷èòåëüíîìó ïîâûøåíèþ åãî êîíöåíòðàöèè â êðîâè, òåì ñàìûì óñëîæíÿÿ îöåíêó ôàðìàêîêèíåòèêè ïîäîáíûõ ËÏ [7].

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     íåêîòîðûõ ñëó÷àÿõ ïðèìåíåíèå äàæå áîëüøîãî êîëè÷åñòâà ËÏ — àíàëîãà ýíäîãåííûõ ñîåäèíåíèé — íå èçìåíÿåò ãîìåîñòàòè÷åñêîãî ðàâíîâåñèÿ ýíäîãåííîãî âåùåñòâà è ïðèâîäèò ê íåçíà÷èòåëüíîìó ïîâûøåíèþ åãî êîíöåíòðàöèè â êðîâè, òåì ñàìûì óñëîæíÿÿ îöåíêó ôàðìàêîêèíåòèêè ïîäîáíûõ ËÏ
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    . Îäíèì èç îñíîâíûõ èçó÷àåìûõ ôàðìàêîêèíåòè÷åñêèõ ïàðàìåòðîâ, êîòîðûé îïðåäåëÿåòñÿ â êëèíè÷åñêîì èññëåäîâàíèè ôàðìàêîêèíåòèêè è íà îñíîâàíèè êîòîðîãî òðàäèöèîííî äåëàåòñÿ âûâîä î ñðàâíèòåëüíîé áèîäîñòóïíîñòè è áèîýêâèâàëåíòíîñòè ïðåïàðàòîâ, ÿâëÿåòñÿ ïëîùàäü ïîä ôàðìàêîêèíåòè÷åñêîé êðèâîé «êîíöåíòðàöèÿ–âðåìÿ »âåùåñòâà (AUC).

8
Investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1). European Medicines Agency. Available from: https:// goo.gl/de2Xjs.
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    âûñîêèé ýíäîãåííûé óðîâåíü êàëüöèÿ è âîëíîîáðàçíîå êîëåáàíèå åãî ïîñëå ïðèåìà ËÏ, ñîäåðæàùåãî êàëüöèé, â êëèíè÷åñêèõ èññëåäîâàíèÿõ íåîáõîäèìî ïðåäóñìàòðèâàòü ðàñ÷åò ôàðìàêîêèíåòè÷åñêèõ ïàðàìåòðîâ ñ ó÷åòîì (âû÷åòîì) ýíäîãåííîãî óðîâíÿ, ÷òî ñîãëàñóåòñÿ ñ ðÿäîì çàðóáåæíûõ è îòå÷åñòâåííûõ ðóêîâîäñòâ: Ðóêîâîäñòâîì Åâðîïåéñêîãî àãåíòñòâà ïî ëåêàðñòâåííûì ñðåäñòâàì (European Medicines Agency, EMA)
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    , Ðóêîâîäñòâîì Óïðàâëåíèÿ ïî êîíòðîëþ çà ïðîäóêòàìè ïèòàíèÿ è ëåêàðñòâåííûìè ñðåäñòâàìè ÑØÀ (Food and Drug Administration, FDA) [9], «Ïðàâèëàìè ïðîâåäåíèÿ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè ëåêàðñòâåííûõ ïðåïàðàòîâ â ðàìêàõ Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà» Åâðàçèéñêîé ýêîíîìè÷åñêîé êîìèññèè [10], «Ðóêîâîäñòâîì ïî ýêñïåðòèçå ëåêàðñòâåííûõ ñðåäñòâ »[11].

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Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. United States Food and Drug Administration. Available from: https:// goo.gl/ikROcx.
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    íåîáõîäèìî ïðåäóñìàòðèâàòü ðàñ÷åò ôàðìàêîêèíåòè÷åñêèõ ïàðàìåòðîâ ñ ó÷åòîì (âû÷åòîì) ýíäîãåííîãî óðîâíÿ, ÷òî ñîãëàñóåòñÿ ñ ðÿäîì çàðóáåæíûõ è îòå÷åñòâåííûõ ðóêîâîäñòâ: Ðóêîâîäñòâîì Åâðîïåéñêîãî àãåíòñòâà ïî ëåêàðñòâåííûì ñðåäñòâàì (European Medicines Agency, EMA) [8], Ðóêîâîäñòâîì Óïðàâëåíèÿ ïî êîíòðîëþ çà ïðîäóêòàìè ïèòàíèÿ è ëåêàðñòâåííûìè ñðåäñòâàìè ÑØÀ (Food and Drug Administration, FDA)
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    , «Ïðàâèëàìè ïðîâåäåíèÿ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè ëåêàðñòâåííûõ ïðåïàðàòîâ â ðàìêàõ Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà» Åâðàçèéñêîé ýêîíîìè÷åñêîé êîìèññèè [10], «Ðóêîâîäñòâîì ïî ýêñïåðòèçå ëåêàðñòâåííûõ ñðåäñòâ »[11].

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On the adoption of Rules for carrying out bioequivalence studies of medicinal products in the Euroasian Economic Union. Council of the Eurasian Economic Commission. Decision of 3 November 2016 No. 85. Available from: https://goo.gl/BBDlFk (in Russian).
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    : Ðóêîâîäñòâîì Åâðîïåéñêîãî àãåíòñòâà ïî ëåêàðñòâåííûì ñðåäñòâàì (European Medicines Agency, EMA) [8], Ðóêîâîäñòâîì Óïðàâëåíèÿ ïî êîíòðîëþ çà ïðîäóêòàìè ïèòàíèÿ è ëåêàðñòâåííûìè ñðåäñòâàìè ÑØÀ (Food and Drug Administration, FDA) [9], «Ïðàâèëàìè ïðîâåäåíèÿ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè ëåêàðñòâåííûõ ïðåïàðàòîâ â ðàìêàõ Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà» Åâðàçèéñêîé ýêîíîìè÷åñêîé êîìèññèè
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    , «Ðóêîâîäñòâîì ïî ýêñïåðòèçå ëåêàðñòâåííûõ ñðåäñòâ »[11].  íàñòîÿùåå âðåìÿ èçó÷åíèþ ôàðìàêîêèíåòèêè ËÏ, ñîäåðæàùèõ èîíû êàëüöèÿ, ïîñâÿùåí ðÿä èññëåäîâàíèé, â êîòîðûõ îñâåùåíû ðàçíûå ïîäõîäû è èçó÷åíû ðàçëè÷íûå ïàðàìåòðû ôàðìàêîêèíåòèêè.

11
Guidance on evaluation of medicines. Vol. I. Moscow: Grif i K; 2013 (in Russian).
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    ñðåäñòâàì (European Medicines Agency, EMA) [8], Ðóêîâîäñòâîì Óïðàâëåíèÿ ïî êîíòðîëþ çà ïðîäóêòàìè ïèòàíèÿ è ëåêàðñòâåííûìè ñðåäñòâàìè ÑØÀ (Food and Drug Administration, FDA) [9], «Ïðàâèëàìè ïðîâåäåíèÿ èññëåäîâàíèé áèîýêâèâàëåíòíîñòè ëåêàðñòâåííûõ ïðåïàðàòîâ â ðàìêàõ Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà» Åâðàçèéñêîé ýêîíîìè÷åñêîé êîìèññèè [10], «Ðóêîâîäñòâîì ïî ýêñïåðòèçå ëåêàðñòâåííûõ ñðåäñòâ »
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    .  íàñòîÿùåå âðåìÿ èçó÷åíèþ ôàðìàêîêèíåòèêè ËÏ, ñîäåðæàùèõ èîíû êàëüöèÿ, ïîñâÿùåí ðÿä èññëåäîâàíèé, â êîòîðûõ îñâåùåíû ðàçíûå ïîäõîäû è èçó÷åíû ðàçëè÷íûå ïàðàìåòðû ôàðìàêîêèíåòèêè. Ñóììèðóÿ èìåþùèéñÿ íàó÷íûé îïûò, öåëåñîîáðàçíî ñîñòàâèòü ïëàí êîìïëåêñíîãî èçó÷åíèÿ ôàðìàêîêèíåòèêè ïîäîáíûõ ïðåïàðàòîâ.

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Kressel G, Wolters M, Hahn A. Bioavailability and Solubility of Different Calcium-Salts as a Basis for Calcium Enrichment of Beverages. Food and Nutrition Sciences 2010; (1): 53–8.
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    gluconate 3 ãÎðàëüíûé A12AA07 calcium chloride0,2 ã Ïàðýíòåðàëüíûé A12AA08 calcium glycerylphosphate A12AA09 calcium citrate lysine complex 0,5 ã Îðàëüíûé A12AA10 calcium glucoheptonate 3 ãÎðàëüíûé A12AA11 calcium pangamate A12AA13 calcium citrate A12AA20 calcium (different salts in combination) 0,5 ã Îðàëüíûé A12AA30 calcium laevulate1 ãÏàðýíòåðàëüíûé  êëèíè÷åñêîì èññëåäîâàíèè
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    , öåëüþ êîòîðîãî áûëî ñðàâíåíèå áèîäîñòóïíîñòè ÷åòûðåõ ËÏ, ñîäåðæàùèõ â ñâîåì ñîñòàâå ðàçëè÷íûå ñîëè êàëüöèÿ (êàëüöèÿ êàðáîíàò, êàëüöèÿ ãëþêîíàò, êàëüöèÿ ëàêòàò ìàëàò è êàëüöèÿ ëàêòàò öèòðàò), ïðèíèìàëè ó÷àñòèå çäîðîâûå äîáðîâîëüöû-ìóæ÷èíû.

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    çíà÷åíèå êîíöåíòðàöèè îáùåãî êàëüöèÿ (Cmax) è çíà÷åíèå ïëîùàäè ïîä êðèâîé «êîíöåíòðàöèÿ êàëüöèÿ–âðåìÿ »(AUC) â ñûâîðîòêå êðîâè äëÿ êàæäîãî èçó÷àåìîãî ïðåïàðàòà áûëè ðàññ÷èòàíû ïóòåì âû÷èòàíèÿ çíà÷åíèÿ, ïîëó÷åííîãî ïðè âçÿòèè íóëåâîé òî÷êè (äî ïðèåìà ïðåïàðàòà), îò ìàêñèìàëüíîãî çíà÷åíèÿ çàðåãèñòðèðîâàííîãî ïîñëå ïîëó÷åíèÿ èçó÷àåìîé äîçû. Ðåçóëüòàòû ïðîâåäåííîãî êëèíè÷åñêîãî èññëåäîâàíèÿ
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    ïîêàçàëè, ÷òî â çàâèñèìîñòè îò ñîëè êàëüöèÿ, êîòîðàÿ ñîäåðæèòñÿ â ËÏ, èç ïðåïàðàòîâ âûñâîáîæäàåòñÿ ðàçëè÷íîå êîëè÷åñòâî êàëüöèÿ, èçó÷àåìûå ïðåïàðàòû ðàçëè÷àþòñÿ ïî ðàñòâîðèìîñòè, à, ñëåäîâàòåëüíî, è ïî áèîäîñòóïíîñòè è ïî ôàðìàêîêèíåòè÷åñêèì ïàðàìåòðàì (Ñmaxè AUC) (òàáë. 3, ðèñ. 2).

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    Òàê, ðàöèîíàëüíûì ÿâëÿåòñÿ èçó÷åíèå âûâåäåíèÿ êàëüöèÿ ñ ìî÷îé äëÿ îöåíêè ñîîòíîøåíèÿ êàëüöèÿ è êðåàòèíèíà, êîòîðîå äîëæíî ñîõðàíÿòüñÿ â ïðåäåëàõ ôèçèîëîãè÷åñêîé íîðìû [15]. Ðèñ. 2.Èçìåíåíèå êîíöåíòðàöèè îáùåãî êàëüöèÿ â ñûâîðîòêå êðîâè â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé
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    Ðèñ. 3.Ñðåäíèå çíà÷åíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé [13] Òàáëèöà 3 ÔÀÐÌÀÊÎÊÈÍÅÒÈ×ÅÑÊÈÅ ÏÀÐÀÌÅÒÐÛ ÊÀËÜÖÈß ×ÅÒÛÐÅÕ ÐÀÇËÈ×ÍÛÕ ÑÎËÅÉ [12] Ñîëü êàëüöèÿ (â òîì ÷èñëå ñìåøàííûå ñîëè) Êîíöåíòðàöèÿ êàëüöèÿ (Ñmax) AUC 0–8 ÷ (ììîëü/ë·÷) iPTH 0–8 ÷ (ïìîëü/ë·÷) Ðàñòâîðèìîñòü â âîäå/ÿáëî÷íîì ñîêå (21 °Ñ) Ìàêñèìàëüíàÿ ðàñòâîðèìîñòü Ca/

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    Ðèñ. 2.Èçìåíåíèå êîíöåíòðàöèè îáùåãî êàëüöèÿ â ñûâîðîòêå êðîâè â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé [12] Ðèñ. 3.Ñðåäíèå çíà÷åíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé [13] Òàáëèöà 3 ÔÀÐÌÀÊÎÊÈÍÅÒÈ×ÅÑÊÈÅ ÏÀÐÀÌÅÒÐÛ ÊÀËÜÖÈß ×ÅÒÛÐÅÕ ÐÀÇËÈ×ÍÛÕ ÑÎËÅÉ
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    Ñîëü êàëüöèÿ (â òîì ÷èñëå ñìåøàííûå ñîëè) Êîíöåíòðàöèÿ êàëüöèÿ (Ñmax) AUC 0–8 ÷ (ììîëü/ë·÷) iPTH 0–8 ÷ (ïìîëü/ë·÷) Ðàñòâîðèìîñòü â âîäå/ÿáëî÷íîì ñîêå (21 °Ñ) Ìàêñèìàëüíàÿ ðàñòâîðèìîñòü Ca/100 ìë H2O // Ca/100 ìë â ÿáëî÷íîì ñîêå CLM (êàëüöèÿ ëàêòàò ìàëàò)18,1 %0,24±0,95–5,82±5,44115/110 ã/ë2082 ìã//1991 ìã CLC (êàëüöèÿ ëàêòàò öèòðàò)16,2 %0,21±0,79–7,17±4,5998/80 ã/ë1588 ìã//1296 ìã CC (êàëüöèÿ êà

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    Êðîìå òîãî, ñíèæåíèå êîíöåíòðàöèè ÏÒà ïîñëå ïðèåìà ËÏ, ñîäåðæàùåãî êàëüöèé, ÿâëÿåòñÿ ïðîÿâëåíèåì áèîëîãè÷åñêè çíà÷èìîãî ýôôåêòà è øèðîêî èñïîëüçóåòñÿ çà ðóáåæîì â êà÷åñòâå êðèòåðèÿ ýôôåêòèâíîñòè ïðè ðåãèñòðàöèè ËÏ, ñîäåðæàùèõ êàëüöèé [16, 17] (ðèñ. 4).  êëèíè÷åñêèõ èññëåäîâàíèÿõ
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    , ïîìèìî îïðåäåëåíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè, èçó÷àëñÿ è óðîâåíü ÏÒà â ñûâîðîòêå êðîâè çäîðîâûõ äîáðîâîëüöåâ-ìóæ÷èí ïîñëå ïðèåìà ËÏ, ñîäåðæàùèõ êàëüöèé. Äëÿ ÏÒà â ñûâîðîòêå êðîâè îïðåäåëÿëèñü ñòàòèñòè÷åñêè çíà÷èìûå èçìåíåíèÿ ïàðàìåòðà â êàæäîé òî÷êå çàáîðà êðîâè ïî ñðàâíåíèþ ñ ôîíîâûìè çíà÷åíèÿìè êîíöåíòðàöèè [14], ïîñêîëüêó èçâåñòíî, ÷òî óðîâåíü ÏÒà ïîäâåðæåí öèðêàäíîìó ðèòì

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    îïðåäåëÿëèñü ñòàòèñòè÷åñêè çíà÷èìûå èçìåíåíèÿ ïàðàìåòðà â êàæäîé òî÷êå çàáîðà êðîâè ïî ñðàâíåíèþ ñ ôîíîâûìè çíà÷åíèÿìè êîíöåíòðàöèè [14], ïîñêîëüêó èçâåñòíî, ÷òî óðîâåíü ÏÒà ïîäâåðæåí öèðêàäíîìó ðèòìó [18].  õîäå èññëåäîâàíèé áûëî îòìå÷åíî èçìåíåíèå êîíöåíòðàöèè ÏÒà â ñûâîðîòêå êðîâè çäîðîâûõ äîáðîâîëüöåâ-ìóæ÷èí â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ËÏ ðàçëè÷íûõ ñîëåé êàëüöèÿ (òàáë. 3, ðèñ. 5)
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    è â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ËÏ ðàçëè÷íûõ ñîëåé êàëüöèÿ (òàáë. 4, ðèñ. 6) [13], à èìåííî çíà÷èòåëüíîå ñíèæåíèå ÏÒÃ. Îäíàêî íåîáõîäèìî îáðàòèòü âíèìàíèå íà ñóùåñòâåííûå ðàçëè÷èÿ, êîòîðûå íàáëþäàþòñÿ â ñíèæåíèè çíà÷åíèÿ ÏÒà â çàâèñèìîñòè îò èçó÷àåìîé ñîëè êàëüöèÿ (òàáë. 3, 4 è ðèñ. 5, 6).

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    39±1,6194769à±334,8 Êàëüöèÿ ïèäîëàò EFICAL® 2,33±0,036924,9à±10,8222,80±3,4255423à,b±694,1 Ãèäðîêñèàïàòèòíûé êîìïëåêñ OSSOPAN® 2,31±0,034922,4à±12,7720,90±2,6146070à,b±508,5 Ïëàöåáî VEHICLE 2,30±0,023893,8b±7,5520,78±2,26380,19,5b±829 Ïðèìå÷àíèå:a:p< 0,05 vs VEHICLE; b:p> 0.05 vs VEHICLE. Ðèñ. 4.Ôàðìàêîäèíàìèêà è ôàðìàêîêèíåòèêà: âñàñûâàíèå êàëüöèÿ è ÏÒà [15, 16] Ïîñêîëüêó â äàííûõ èññëåäîâàíèÿõ
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    ïðèíèìàëè ó÷àñòèå òîëüêî ìóæ÷èíû, ïîëó÷åííûå ðåçóëüòàòû òðóäíî ýêñòðàïîëèðîâàòü íà äðóãèå ïîïóëÿöèè, íàïðèìåð, íà æåíùèí â ïîñòìåíîïàóçå, òàê êàê èçâåñòíî, ÷òî ñûâîðîòî÷íûå êîíöåíòðàöèè îáùåãî êàëüöèÿ è ñîäåðæàíèå ÏÒà íàõîäÿòñÿ ïîä âëèÿíèåì ýñòðîãåíîâ [19–21].

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    êàëüöèÿ è ÏÒà [15, 16] Ïîñêîëüêó â äàííûõ èññëåäîâàíèÿõ [12, 13] ïðèíèìàëè ó÷àñòèå òîëüêî ìóæ÷èíû, ïîëó÷åííûå ðåçóëüòàòû òðóäíî ýêñòðàïîëèðîâàòü íà äðóãèå ïîïóëÿöèè, íàïðèìåð, íà æåíùèí â ïîñòìåíîïàóçå, òàê êàê èçâåñòíî, ÷òî ñûâîðîòî÷íûå êîíöåíòðàöèè îáùåãî êàëüöèÿ è ñîäåðæàíèå ÏÒà íàõîäÿòñÿ ïîä âëèÿíèåì ýñòðîãåíîâ [19–21]. Îäíàêî, ðåçóëüòàòû, ïîëó÷åííûå â äàííûõ êëèíè÷åñêèõ èññëåäîâàíèÿõ
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    , ñõîäíû ñ îïèñàííûìè â íàó÷íîé ëèòåðàòóðå [22–29].  îòíîøåíèè ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé — â íàñòîÿùåå âðåìÿ â Ðîññèéñêîé Ôåäåðàöèè îòñóòñòâóþò íîðìàòèâíî-ïðàâîâûå àêòû, êîòîðûå ðåãóëèðóþò ïðàâèëà ïðîâåäåíèÿ ôàðìàêîêèíåòè÷åñêèõ èññëåäîâàíèéin vivoäëÿ êîíêðåòíûõ ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé [1].

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    Ðèñ. 6.Ñðåäíèå çíà÷åíèÿ êîíöåíòðàöèè ïàðàòèðåîèäíîãî ãîðìîíà â ñûâîðîòêè êðîâè â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé [13] Ðèñ. 5.Èçìåíåíèå êîíöåíòðàöèè ïàðàòèðåîèäíîãî ãîðìîíà â ñûâîðîòêå êðîâè â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé
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    19. Jacono JJ, Robertson JM. The Effects of Estrogen, Progesterone, and Ionized Calcium on Seizures during the Menstrual Cycle of Epileptic Women. Epilepsia 1987; 28(5): 571–7. 20. Pitkin RM, Reynolds WA, Williams GA, Hargis GK.

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Deroisy R, Zartarian M, Meurmans L, Nelissenns N, Micheletti MC, Albert A, Reginster JY. Acute hormone intake of changes in serum calcium and parathyroid circulating levels induced by the oral five currently available calcium salts in healthy male volunteers. Clinical Rheumatology 1997, 16(3): 249–53. Available from: https:// goo.gl/93Cm40.
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    Ðåçóëüòàòû ïðîâåäåííîãî êëèíè÷åñêîãî èññëåäîâàíèÿ [12] ïîêàçàëè, ÷òî â çàâèñèìîñòè îò ñîëè êàëüöèÿ, êîòîðàÿ ñîäåðæèòñÿ â ËÏ, èç ïðåïàðàòîâ âûñâîáîæäàåòñÿ ðàçëè÷íîå êîëè÷åñòâî êàëüöèÿ, èçó÷àåìûå ïðåïàðàòû ðàçëè÷àþòñÿ ïî ðàñòâîðèìîñòè, à, ñëåäîâàòåëüíî, è ïî áèîäîñòóïíîñòè è ïî ôàðìàêîêèíåòè÷åñêèì ïàðàìåòðàì (Ñmaxè AUC) (òàáë. 3, ðèñ. 2).  äðóãîì êëèíè÷åñêîì èññëåäîâàíèè
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    ñ ó÷àñòèåì çäîðîâûõ äîáðîâîëüöåâ èçó÷àëèñü ËÏ ïÿòè ðàçëè÷íûõ ñîëåé êàëüöèÿ (êàëüöèÿ êàðáîíàò, êàëüöèÿ ãëþêîíàò, êàëüöèÿ öèòðàò, êàëüöèÿ ïèäîëàò, êàëüöèÿ ãèäðîêñèàïàòèòíûé êîìïëåêñ) â ñðàâíåíèè ñ ïëàöåáî.

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    Áûëî îòìå÷åíî, ÷òî ïðèìåíåíèå âñåõ èçó÷àåìûõ ËÏ âûçûâàëî çíà÷èòåëüíîå óâåëè÷åíèå êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè, îäíàêî ýòî óâåëè÷åíèå áûëî ñòàòèñòè÷åñêè ðàçëè÷íûì â çàâèñèìîñòè îò èçó÷àåìîé ñîëè êàëüöèÿ
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    . Òàêèì îáðàçîì, ïðè ïëàíèðîâàíèè ñðàâíèòåëüíûõ êëèíè÷åñêèõ èññëåäîâàíèé äëÿ èçó÷åíèÿ ôàðìàêîêèíåòèêè ËÏ, ñîäåðæàùèõ èîíû êàëüöèÿ, îñîáîå âíèìàíèå íåîáõîäèìî îáðàùàòü íà ñîëè êàëüöèÿ, êîòîðûå ñîäåðæàòñÿ â èçó÷àåìîì ïðåïàðàòå (òàáë. 1) [2].

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    Ðèñ. 2.Èçìåíåíèå êîíöåíòðàöèè îáùåãî êàëüöèÿ â ñûâîðîòêå êðîâè â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé [12] Ðèñ. 3.Ñðåäíèå çíà÷åíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé
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    Òàáëèöà 3 ÔÀÐÌÀÊÎÊÈÍÅÒÈ×ÅÑÊÈÅ ÏÀÐÀÌÅÒÐÛ ÊÀËÜÖÈß ×ÅÒÛÐÅÕ ÐÀÇËÈ×ÍÛÕ ÑÎËÅÉ [12] Ñîëü êàëüöèÿ (â òîì ÷èñëå ñìåøàííûå ñîëè) Êîíöåíòðàöèÿ êàëüöèÿ (Ñmax) AUC 0–8 ÷ (ììîëü/ë·÷) iPTH 0–8 ÷ (ïìîëü/ë·÷) Ðàñòâîðèìîñòü â âîäå/ÿáëî÷íîì ñîêå (21 °Ñ) Ìàêñèìàëüíàÿ ðàñòâîðèìîñòü Ca/100 ìë H2O // Ca/100 ìë â ÿáëî÷íîì ñîêå CLM (êàëüöèÿ ëàêòàò ìàëàò)18,1 %0,24±0,95–5,82±5,44115/110 ã/ë2082 ìã//1991 ìã CLC (êàëüöèÿ ëà

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    Êðîìå òîãî, ñíèæåíèå êîíöåíòðàöèè ÏÒà ïîñëå ïðèåìà ËÏ, ñîäåðæàùåãî êàëüöèé, ÿâëÿåòñÿ ïðîÿâëåíèåì áèîëîãè÷åñêè çíà÷èìîãî ýôôåêòà è øèðîêî èñïîëüçóåòñÿ çà ðóáåæîì â êà÷åñòâå êðèòåðèÿ ýôôåêòèâíîñòè ïðè ðåãèñòðàöèè ËÏ, ñîäåðæàùèõ êàëüöèé [16, 17] (ðèñ. 4).  êëèíè÷åñêèõ èññëåäîâàíèÿõ
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    , ïîìèìî îïðåäåëåíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè, èçó÷àëñÿ è óðîâåíü ÏÒà â ñûâîðîòêå êðîâè çäîðîâûõ äîáðîâîëüöåâ-ìóæ÷èí ïîñëå ïðèåìà ËÏ, ñîäåðæàùèõ êàëüöèé. Äëÿ ÏÒà â ñûâîðîòêå êðîâè îïðåäåëÿëèñü ñòàòèñòè÷åñêè çíà÷èìûå èçìåíåíèÿ ïàðàìåòðà â êàæäîé òî÷êå çàáîðà êðîâè ïî ñðàâíåíèþ ñ ôîíîâûìè çíà÷åíèÿìè êîíöåíòðàöèè [14], ïîñêîëüêó èçâåñòíî, ÷òî óðîâåíü ÏÒà ïîäâåðæåí öèðêàäíîìó ðèòì

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     õîäå èññëåäîâàíèé áûëî îòìå÷åíî èçìåíåíèå êîíöåíòðàöèè ÏÒà â ñûâîðîòêå êðîâè çäîðîâûõ äîáðîâîëüöåâ-ìóæ÷èí â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ËÏ ðàçëè÷íûõ ñîëåé êàëüöèÿ (òàáë. 3, ðèñ. 5) [12] è â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ËÏ ðàçëè÷íûõ ñîëåé êàëüöèÿ (òàáë. 4, ðèñ. 6)
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    , à èìåííî çíà÷èòåëüíîå ñíèæåíèå ÏÒÃ. Îäíàêî íåîáõîäèìî îáðàòèòü âíèìàíèå íà ñóùåñòâåííûå ðàçëè÷èÿ, êîòîðûå íàáëþäàþòñÿ â ñíèæåíèè çíà÷åíèÿ ÏÒà â çàâèñèìîñòè îò èçó÷àåìîé ñîëè êàëüöèÿ (òàáë. 3, 4 è ðèñ. 5, 6).

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    Îäíàêî íåîáõîäèìî îáðàòèòü âíèìàíèå íà ñóùåñòâåííûå ðàçëè÷èÿ, êîòîðûå íàáëþäàþòñÿ â ñíèæåíèè çíà÷åíèÿ ÏÒà â çàâèñèìîñòè îò èçó÷àåìîé ñîëè êàëüöèÿ (òàáë. 3, 4 è ðèñ. 5, 6). Òàáëèöà 4 ÑÐÅÄÍÅÅ ÇÍÀ×ÅÍÈÅ ÑÛÂÎÐÎÒÊÈ ÊÀËÜÖÈß (CALCIUM) È ÏÀÐÀÒÃÎÐÌÎÍÀ (PTH) Ó ÇÄÎÐÎÂÛÕ ÄÎÁÐÎÂÎËÜÖÅ (N= 18) ÄÎ È ÏÎÑËÅ ÏÐÈÌÅÍÅÍÈß ÈÑÑËÅÄÓÅÌÛÕ ÏÐÅÏÀÐÀÒÎÂ
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    CALCIUMPTH Äî ïðèìåíåíèÿ ïðåïàðàòà normal range (2,15–2,55) (ììîëü/ël) Ïîñëå ïðèìåíåíèÿ ïðåïàðàòà AUC (ììîëü/ë·ìèí) 0–360 Äî ïðèìåíåíèÿ ïðåïàðàòà normal range (10–65) (ïã/ìë) Ïîñëå ïðèìåíåíèÿ ïðåïàðàòà AUC (ïã/ìë·ìèí) 0–360 TREATMENTm±semm±sem Êàëüöèÿ êàðáîíàò OROCAL® 2,34±0,034934,8à±9,1418,55±1,8974705à±359,5 Êàëüöèÿ ãëþêîíàò SANDOCAL® 2,38±0,039936,9à±10,3119,22±2,2165193à,b±425,1 Êàëüöèÿ öèòð

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    39±1,6194769à±334,8 Êàëüöèÿ ïèäîëàò EFICAL® 2,33±0,036924,9à±10,8222,80±3,4255423à,b±694,1 Ãèäðîêñèàïàòèòíûé êîìïëåêñ OSSOPAN® 2,31±0,034922,4à±12,7720,90±2,6146070à,b±508,5 Ïëàöåáî VEHICLE 2,30±0,023893,8b±7,5520,78±2,26380,19,5b±829 Ïðèìå÷àíèå:a:p< 0,05 vs VEHICLE; b:p> 0.05 vs VEHICLE. Ðèñ. 4.Ôàðìàêîäèíàìèêà è ôàðìàêîêèíåòèêà: âñàñûâàíèå êàëüöèÿ è ÏÒà [15, 16] Ïîñêîëüêó â äàííûõ èññëåäîâàíèÿõ
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    ïðèíèìàëè ó÷àñòèå òîëüêî ìóæ÷èíû, ïîëó÷åííûå ðåçóëüòàòû òðóäíî ýêñòðàïîëèðîâàòü íà äðóãèå ïîïóëÿöèè, íàïðèìåð, íà æåíùèí â ïîñòìåíîïàóçå, òàê êàê èçâåñòíî, ÷òî ñûâîðîòî÷íûå êîíöåíòðàöèè îáùåãî êàëüöèÿ è ñîäåðæàíèå ÏÒà íàõîäÿòñÿ ïîä âëèÿíèåì ýñòðîãåíîâ [19–21].

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    êàëüöèÿ è ÏÒà [15, 16] Ïîñêîëüêó â äàííûõ èññëåäîâàíèÿõ [12, 13] ïðèíèìàëè ó÷àñòèå òîëüêî ìóæ÷èíû, ïîëó÷åííûå ðåçóëüòàòû òðóäíî ýêñòðàïîëèðîâàòü íà äðóãèå ïîïóëÿöèè, íàïðèìåð, íà æåíùèí â ïîñòìåíîïàóçå, òàê êàê èçâåñòíî, ÷òî ñûâîðîòî÷íûå êîíöåíòðàöèè îáùåãî êàëüöèÿ è ñîäåðæàíèå ÏÒà íàõîäÿòñÿ ïîä âëèÿíèåì ýñòðîãåíîâ [19–21]. Îäíàêî, ðåçóëüòàòû, ïîëó÷åííûå â äàííûõ êëèíè÷åñêèõ èññëåäîâàíèÿõ
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    , ñõîäíû ñ îïèñàííûìè â íàó÷íîé ëèòåðàòóðå [22–29].  îòíîøåíèè ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé — â íàñòîÿùåå âðåìÿ â Ðîññèéñêîé Ôåäåðàöèè îòñóòñòâóþò íîðìàòèâíî-ïðàâîâûå àêòû, êîòîðûå ðåãóëèðóþò ïðàâèëà ïðîâåäåíèÿ ôàðìàêîêèíåòè÷åñêèõ èññëåäîâàíèéin vivoäëÿ êîíêðåòíûõ ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé [1].

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    Journal of Clinical Endocrinology and Metabolism 1997; 82(1): 281–6. Ðèñ. 6.Ñðåäíèå çíà÷åíèÿ êîíöåíòðàöèè ïàðàòèðåîèäíîãî ãîðìîíà â ñûâîðîòêè êðîâè â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé
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    Ðèñ. 5.Èçìåíåíèå êîíöåíòðàöèè ïàðàòèðåîèäíîãî ãîðìîíà â ñûâîðîòêå êðîâè â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé [12] 19. Jacono JJ, Robertson JM. The Effects of Estrogen, Progesterone, and Ionized Calcium on Seizures during the Menstrual Cycle of Epileptic Women.

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Godfrey K. Statistics in practice: comparing the means of several groups. N Engl J Med. 1985; 313(23): 1450–6.
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    Äëÿ êàæäîãî èçó÷àåìîãî ïðåïàðàòà îïðåäåëÿëèñü ñòàòèñòè÷åñêè çíà÷èìûå èçìåíåíèÿ ïëîùàäè ïîä êðèâîé «êîíöåíòðàöèÿ êàëüöèÿ–âðåìÿ »(AUC) â êàæäîé òî÷êå çàáîðà êðîâè ïî ñðàâíåíèþ ñ ôîíîâûìè çíà÷åíèÿìè êîíöåíòðàöèè, ïðè èñïîëüçîâàíèè ïîïðàâêè Áîíôåðîíè äëÿ ìíîæåñòâåííûõ ñðàâíåíèé
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    .  õîäå èññëåäîâàíèÿ íàáëþäàëîñü èçìåíåíèå êîíöåíòðàöèè îáùåãî êàëüöèÿ â ñûâîðîòêå êðîâè â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé (òàáë. 4, ðèñ. 3). Áûëî îòìå÷åíî, ÷òî ïðèìåíåíèå âñåõ èçó÷àåìûõ ËÏ âûçûâàëî çíà÷èòåëüíîå óâåëè÷åíèå êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè, îäíàêî ýòî óâåëè÷åíèå áûëî ñòàòèñòè÷åñêè ðàçëè÷íûì â çàâèñèìîñòè îò èçó÷àåìîé ñîëè êàëüöèÿ [13].

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     êëèíè÷åñêèõ èññëåäîâàíèÿõ [12, 13], ïîìèìî îïðåäåëåíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè, èçó÷àëñÿ è óðîâåíü ÏÒà â ñûâîðîòêå êðîâè çäîðîâûõ äîáðîâîëüöåâ-ìóæ÷èí ïîñëå ïðèåìà ËÏ, ñîäåðæàùèõ êàëüöèé. Äëÿ ÏÒà â ñûâîðîòêå êðîâè îïðåäåëÿëèñü ñòàòèñòè÷åñêè çíà÷èìûå èçìåíåíèÿ ïàðàìåòðà â êàæäîé òî÷êå çàáîðà êðîâè ïî ñðàâíåíèþ ñ ôîíîâûìè çíà÷åíèÿìè êîíöåíòðàöèè
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    , ïîñêîëüêó èçâåñòíî, ÷òî óðîâåíü ÏÒà ïîäâåðæåí öèðêàäíîìó ðèòìó [18].  õîäå èññëåäîâàíèé áûëî îòìå÷åíî èçìåíåíèå êîíöåíòðàöèè ÏÒà â ñûâîðîòêå êðîâè çäîðîâûõ äîáðîâîëüöåâ-ìóæ÷èí â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ËÏ ðàçëè÷íûõ ñîëåé êàëüöèÿ (òàáë. 3, ðèñ. 5) [12] è â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ËÏ ðàçëè÷íûõ ñîëåé êàëüöèÿ (òàáë. 4, ðèñ. 6) [13], à èìåííî çíà÷èòåëüíîå ñíèæåíèå ÏÒÃ.

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Dissanayake S. Assessing the bioequivalence of analogues of endogenous substances («endogenous drugs»): considerations to optimize study design. Br J Clin Pharmacol. 2010; 69(3): 238–44.
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    Äëÿ êîìïëåêñíîé îöåíêè ôàðìàêîêèíåòèêè ËÏ, ñîäåðæàùèõ â ñâîåì ñîñòàâå ñîëè êàëüöèÿ, ïîìèìî îïðåäåëåíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè, íåîáõîäèìî ó÷èòûâàòü ñóùåñòâóþùèå ãîìåîñòàòè÷åñêèå ìåõàíèçìû, êîòîðûå ïîääåðæèâàþò óðîâåíü êàëüöèÿ â ïðåäåëàõ ôèçèîëîãè÷åñêîé íîðìû
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    . Òàê, ðàöèîíàëüíûì ÿâëÿåòñÿ èçó÷åíèå âûâåäåíèÿ êàëüöèÿ ñ ìî÷îé äëÿ îöåíêè ñîîòíîøåíèÿ êàëüöèÿ è êðåàòèíèíà, êîòîðîå äîëæíî ñîõðàíÿòüñÿ â ïðåäåëàõ ôèçèîëîãè÷åñêîé íîðìû [15]. Ðèñ. 2.Èçìåíåíèå êîíöåíòðàöèè îáùåãî êàëüöèÿ â ñûâîðîòêå êðîâè â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé [12] Ðèñ. 3.

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    â ñâîåì ñîñòàâå ñîëè êàëüöèÿ, ïîìèìî îïðåäåëåíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè, íåîáõîäèìî ó÷èòûâàòü ñóùåñòâóþùèå ãîìåîñòàòè÷åñêèå ìåõàíèçìû, êîòîðûå ïîääåðæèâàþò óðîâåíü êàëüöèÿ â ïðåäåëàõ ôèçèîëîãè÷åñêîé íîðìû [15]. Òàê, ðàöèîíàëüíûì ÿâëÿåòñÿ èçó÷åíèå âûâåäåíèÿ êàëüöèÿ ñ ìî÷îé äëÿ îöåíêè ñîîòíîøåíèÿ êàëüöèÿ è êðåàòèíèíà, êîòîðîå äîëæíî ñîõðàíÿòüñÿ â ïðåäåëàõ ôèçèîëîãè÷åñêîé íîðìû
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    . Ðèñ. 2.Èçìåíåíèå êîíöåíòðàöèè îáùåãî êàëüöèÿ â ñûâîðîòêå êðîâè â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé [12] Ðèñ. 3.Ñðåäíèå çíà÷åíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ïðåïàðàòîâ êàëüöèÿ ðàçëè÷íûõ ñîëåé [13] Òàáëèöà 3 ÔÀÐÌÀÊÎÊÈÍÅÒÈ×ÅÑÊÈÅ ÏÀÐÀÌÅÒÐÛ ÊÀËÜÖÈß ×ÅÒÛÐÅÕ ÐÀÇËÈ×ÍÛÕ ÑÎËÅÉ [12] Ñîëü êàëüöèÿ (â òîì ÷èñëå ñìåøàííûå ñîëè) Êîíöåíòðàöè

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    öèòðàò CACIT® 2,30±0,027935,6à±9,5318,39±1,6194769à±334,8 Êàëüöèÿ ïèäîëàò EFICAL® 2,33±0,036924,9à±10,8222,80±3,4255423à,b±694,1 Ãèäðîêñèàïàòèòíûé êîìïëåêñ OSSOPAN® 2,31±0,034922,4à±12,7720,90±2,6146070à,b±508,5 Ïëàöåáî VEHICLE 2,30±0,023893,8b±7,5520,78±2,26380,19,5b±829 Ïðèìå÷àíèå:a:p< 0,05 vs VEHICLE; b:p> 0.05 vs VEHICLE. Ðèñ. 4.Ôàðìàêîäèíàìèêà è ôàðìàêîêèíåòèêà: âñàñûâàíèå êàëüöèÿ è ÏÒÃ
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    Ïîñêîëüêó â äàííûõ èññëåäîâàíèÿõ [12, 13] ïðèíèìàëè ó÷àñòèå òîëüêî ìóæ÷èíû, ïîëó÷åííûå ðåçóëüòàòû òðóäíî ýêñòðàïîëèðîâàòü íà äðóãèå ïîïóëÿöèè, íàïðèìåð, íà æåíùèí â ïîñòìåíîïàóçå, òàê êàê èçâåñòíî, ÷òî ñûâîðîòî÷íûå êîíöåíòðàöèè îáùåãî êàëüöèÿ è ñîäåðæàíèå ÏÒà íàõîäÿòñÿ ïîä âëèÿíèåì ýñòðîãåíîâ [19–21].

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Marzo A. Master Universitario di II Livello Ricerca e Sviluppo PreClinico e Clinico del Farmaco Modulo 4. Sviluppo Clinico dei Farmaci Chieti, 14–15 novembre 2013.
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    Êðîìå òîãî, ñíèæåíèå êîíöåíòðàöèè ÏÒà ïîñëå ïðèåìà ËÏ, ñîäåðæàùåãî êàëüöèé, ÿâëÿåòñÿ ïðîÿâëåíèåì áèîëîãè÷åñêè çíà÷èìîãî ýôôåêòà è øèðîêî èñïîëüçóåòñÿ çà ðóáåæîì â êà÷åñòâå êðèòåðèÿ ýôôåêòèâíîñòè ïðè ðåãèñòðàöèè ËÏ, ñîäåðæàùèõ êàëüöèé
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    [16, 17]
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    (ðèñ. 4).  êëèíè÷åñêèõ èññëåäîâàíèÿõ [12, 13], ïîìèìî îïðåäåëåíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè, èçó÷àëñÿ è óðîâåíü ÏÒà â ñûâîðîòêå êðîâè çäîðîâûõ äîáðîâîëüöåâ-ìóæ÷èí ïîñëå ïðèåìà ËÏ, ñîäåðæàùèõ êàëüöèé.

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    öèòðàò CACIT® 2,30±0,027935,6à±9,5318,39±1,6194769à±334,8 Êàëüöèÿ ïèäîëàò EFICAL® 2,33±0,036924,9à±10,8222,80±3,4255423à,b±694,1 Ãèäðîêñèàïàòèòíûé êîìïëåêñ OSSOPAN® 2,31±0,034922,4à±12,7720,90±2,6146070à,b±508,5 Ïëàöåáî VEHICLE 2,30±0,023893,8b±7,5520,78±2,26380,19,5b±829 Ïðèìå÷àíèå:a:p< 0,05 vs VEHICLE; b:p> 0.05 vs VEHICLE. Ðèñ. 4.Ôàðìàêîäèíàìèêà è ôàðìàêîêèíåòèêà: âñàñûâàíèå êàëüöèÿ è ÏÒÃ
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    [15, 16]
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    Ïîñêîëüêó â äàííûõ èññëåäîâàíèÿõ [12, 13] ïðèíèìàëè ó÷àñòèå òîëüêî ìóæ÷èíû, ïîëó÷åííûå ðåçóëüòàòû òðóäíî ýêñòðàïîëèðîâàòü íà äðóãèå ïîïóëÿöèè, íàïðèìåð, íà æåíùèí â ïîñòìåíîïàóçå, òàê êàê èçâåñòíî, ÷òî ñûâîðîòî÷íûå êîíöåíòðàöèè îáùåãî êàëüöèÿ è ñîäåðæàíèå ÏÒà íàõîäÿòñÿ ïîä âëèÿíèåì ýñòðîãåíîâ [19–21].

17
Marzo A. Open questions on bioequivalence: some problems and some solutions. Pharmacol Res. 1999; 40(4): 357–68.
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    Êðîìå òîãî, ñíèæåíèå êîíöåíòðàöèè ÏÒà ïîñëå ïðèåìà ËÏ, ñîäåðæàùåãî êàëüöèé, ÿâëÿåòñÿ ïðîÿâëåíèåì áèîëîãè÷åñêè çíà÷èìîãî ýôôåêòà è øèðîêî èñïîëüçóåòñÿ çà ðóáåæîì â êà÷åñòâå êðèòåðèÿ ýôôåêòèâíîñòè ïðè ðåãèñòðàöèè ËÏ, ñîäåðæàùèõ êàëüöèé
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    [16, 17]
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    (ðèñ. 4).  êëèíè÷åñêèõ èññëåäîâàíèÿõ [12, 13], ïîìèìî îïðåäåëåíèÿ êîíöåíòðàöèè êàëüöèÿ â ñûâîðîòêå êðîâè, èçó÷àëñÿ è óðîâåíü ÏÒà â ñûâîðîòêå êðîâè çäîðîâûõ äîáðîâîëüöåâ-ìóæ÷èí ïîñëå ïðèåìà ËÏ, ñîäåðæàùèõ êàëüöèé.

18
El-Hajj Fuleihan G, Klerman EB, Brown EN, Choe Y, Brown EM, Czeisler CA. The Parathyroid Hormone Circadian Rhythm Is Truly Endogenous — A General Clinical Research Center Study. Journal of Clinical Endocrinology and Metabolism 1997; 82(1): 281–6.
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    Äëÿ ÏÒà â ñûâîðîòêå êðîâè îïðåäåëÿëèñü ñòàòèñòè÷åñêè çíà÷èìûå èçìåíåíèÿ ïàðàìåòðà â êàæäîé òî÷êå çàáîðà êðîâè ïî ñðàâíåíèþ ñ ôîíîâûìè çíà÷åíèÿìè êîíöåíòðàöèè [14], ïîñêîëüêó èçâåñòíî, ÷òî óðîâåíü ÏÒà ïîäâåðæåí öèðêàäíîìó ðèòìó
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    [18]
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    .  õîäå èññëåäîâàíèé áûëî îòìå÷åíî èçìåíåíèå êîíöåíòðàöèè ÏÒà â ñûâîðîòêå êðîâè çäîðîâûõ äîáðîâîëüöåâ-ìóæ÷èí â òå÷åíèå 8 ÷àñîâ ïîñëå ïðèåìà ËÏ ðàçëè÷íûõ ñîëåé êàëüöèÿ (òàáë. 3, ðèñ. 5) [12] è â òå÷åíèå 6 ÷àñîâ ïîñëå ïðèåìà ËÏ ðàçëè÷íûõ ñîëåé êàëüöèÿ (òàáë. 4, ðèñ. 6) [13], à èìåííî çíà÷èòåëüíîå ñíèæåíèå ÏÒÃ.

19
Jacono JJ, Robertson JM. The Effects of Estrogen, Progesterone, and Ionized Calcium on Seizures during the Menstrual Cycle of Epileptic Women. Epilepsia 1987; 28(5): 571–7.
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    Ðèñ. 4.Ôàðìàêîäèíàìèêà è ôàðìàêîêèíåòèêà: âñàñûâàíèå êàëüöèÿ è ÏÒà [15, 16] Ïîñêîëüêó â äàííûõ èññëåäîâàíèÿõ [12, 13] ïðèíèìàëè ó÷àñòèå òîëüêî ìóæ÷èíû, ïîëó÷åííûå ðåçóëüòàòû òðóäíî ýêñòðàïîëèðîâàòü íà äðóãèå ïîïóëÿöèè, íàïðèìåð, íà æåíùèí â ïîñòìåíîïàóçå, òàê êàê èçâåñòíî, ÷òî ñûâîðîòî÷íûå êîíöåíòðàöèè îáùåãî êàëüöèÿ è ñîäåðæàíèå ÏÒà íàõîäÿòñÿ ïîä âëèÿíèåì ýñòðîãåíîâ
    Exact
    [19–21]
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    . Îäíàêî, ðåçóëüòàòû, ïîëó÷åííûå â äàííûõ êëèíè÷åñêèõ èññëåäîâàíèÿõ [12, 13], ñõîäíû ñ îïèñàííûìè â íàó÷íîé ëèòåðàòóðå [22–29].  îòíîøåíèè ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé — â íàñòîÿùåå âðåìÿ â Ðîññèéñêîé Ôåäåðàöèè îòñóòñòâóþò íîðìàòèâíî-ïðàâîâûå àêòû, êîòîðûå ðåãóëèðóþò ïðàâèëà ïðîâåäåíèÿ ôàðìàêîêèíåòè÷åñêèõ èññëåäîâàíèéin vivoäëÿ êîíêðåòíûõ ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé [1].

22
Ekman M, Reizenstein R, Teigen SW, Ronneberg R. Comparative absorption of calcium from carbonate tablets, lactogluconate/carbonate effervescent tablet and chloride solution. Bone 1991; 12(2): 93–7.
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    [12, 13] ïðèíèìàëè ó÷àñòèå òîëüêî ìóæ÷èíû, ïîëó÷åííûå ðåçóëüòàòû òðóäíî ýêñòðàïîëèðîâàòü íà äðóãèå ïîïóëÿöèè, íàïðèìåð, íà æåíùèí â ïîñòìåíîïàóçå, òàê êàê èçâåñòíî, ÷òî ñûâîðîòî÷íûå êîíöåíòðàöèè îáùåãî êàëüöèÿ è ñîäåðæàíèå ÏÒà íàõîäÿòñÿ ïîä âëèÿíèåì ýñòðîãåíîâ [19–21]. Îäíàêî, ðåçóëüòàòû, ïîëó÷åííûå â äàííûõ êëèíè÷åñêèõ èññëåäîâàíèÿõ [12, 13], ñõîäíû ñ îïèñàííûìè â íàó÷íîé ëèòåðàòóðå
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    [22–29]
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    .  îòíîøåíèè ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé — â íàñòîÿùåå âðåìÿ â Ðîññèéñêîé Ôåäåðàöèè îòñóòñòâóþò íîðìàòèâíî-ïðàâîâûå àêòû, êîòîðûå ðåãóëèðóþò ïðàâèëà ïðîâåäåíèÿ ôàðìàêîêèíåòè÷åñêèõ èññëåäîâàíèéin vivoäëÿ êîíêðåòíûõ ËÏ — àíàëîãîâ ýíäîãåííûõ ñîåäèíåíèé [1].