Test system for the detection of binding antibodies to interferon beta-1a for clinical use

Test system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The...
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Autor*in:	E. A. Kuzminova [verfasserIn] T. Yu. Ostroukhova [verfasserIn] A. V. Grachev [verfasserIn] E. L. Morozova [verfasserIn]

Format:	E-Artikel
Sprache:	Russisch

Erschienen:	2018

Schlagwörter:	интерферон бета 1а иммуногенность твердофазный иммуноферментный анализ (ифа) связывающие антитела (сат) антитела к препарату рассеянный склероз биоаналитические методы исследования клинические исследования interferon beta-1a immunogenicity enzyme linked immunosorbent assay (elisa) binding antibodies (bab) anti-drug antibodies (adas) multiple sclerosis (ms) bioanalytical methods clinical studies

Übergeordnetes Werk:	In: Биопрепараты: Профилактика, диагностика, лечение - Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2018, 16(2018), 3, Seite 182-188
Übergeordnetes Werk:	volume:16 ; year:2018 ; number:3 ; pages:182-188

Links:	Link aufrufen Link aufrufen Journal toc Journal toc

Katalog-ID:	DOAJ004486757

Internformat


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520			\|a Test system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The applicability of the mentioned test system has been approved for the use in clinical studies for the evaluation of interferon beta-1a immunogenicity (pegylated and non-pegylated forms).
650		4	\|a интерферон бета 1а
650		4	\|a иммуногенность
650		4	\|a твердофазный иммуноферментный анализ (ифа)
650		4	\|a связывающие антитела (сат)
650		4	\|a антитела к препарату
650		4	\|a рассеянный склероз
650		4	\|a биоаналитические методы исследования
650		4	\|a клинические исследования
650		4	\|a interferon beta-1a
650		4	\|a immunogenicity
650		4	\|a enzyme linked immunosorbent assay (elisa)
650		4	\|a binding antibodies (bab)
650		4	\|a anti-drug antibodies (adas)
650		4	\|a multiple sclerosis (ms)
650		4	\|a bioanalytical methods
650		4	\|a clinical studies
653		0	\|a Biotechnology
653		0	\|a Medicine
653		0	\|a R
700	0		\|a T. Yu. Ostroukhova \|e verfasserin \|4 aut
700	0		\|a A. V. Grachev \|e verfasserin \|4 aut
700	0		\|a E. L. Morozova \|e verfasserin \|4 aut
773	0	8	\|i In \|t Биопрепараты: Профилактика, диагностика, лечение \|d Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2018 \|g 16(2018), 3, Seite 182-188 \|w (DE-627)1760620254 \|x 26191156 \|7 nnns
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856	4	2	\|u https://doaj.org/toc/2619-1156 \|y Journal toc \|z kostenfrei
912			\|a GBV_USEFLAG_A
912			\|a SYSFLAG_A
912			\|a GBV_DOAJ
912			\|a GBV_ILN_20
912			\|a GBV_ILN_22
912			\|a GBV_ILN_23
912			\|a GBV_ILN_24
912			\|a GBV_ILN_31
912			\|a GBV_ILN_39
912			\|a GBV_ILN_40
912			\|a GBV_ILN_60
912			\|a GBV_ILN_62
912			\|a GBV_ILN_63
912			\|a GBV_ILN_65
912			\|a GBV_ILN_69
912			\|a GBV_ILN_73
912			\|a GBV_ILN_74
912			\|a GBV_ILN_95
912			\|a GBV_ILN_105
912			\|a GBV_ILN_110
912			\|a GBV_ILN_151
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912			\|a GBV_ILN_170
912			\|a GBV_ILN_206
912			\|a GBV_ILN_213
912			\|a GBV_ILN_230
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912			\|a GBV_ILN_293
912			\|a GBV_ILN_602
912			\|a GBV_ILN_2014
912			\|a GBV_ILN_4012
912			\|a GBV_ILN_4037
912			\|a GBV_ILN_4112
912			\|a GBV_ILN_4125
912			\|a GBV_ILN_4126
912			\|a GBV_ILN_4249
912			\|a GBV_ILN_4305
912			\|a GBV_ILN_4306
912			\|a GBV_ILN_4307
912			\|a GBV_ILN_4313
912			\|a GBV_ILN_4322
912			\|a GBV_ILN_4323
912			\|a GBV_ILN_4324
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912			\|a GBV_ILN_4338
912			\|a GBV_ILN_4367
912			\|a GBV_ILN_4700
951			\|a AR
952			\|d 16 \|j 2018 \|e 3 \|h 182-188

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spelling	(DE-627)DOAJ004486757 (DE-599)DOAJd5d68f37f91240af8fccdb7b5e3909e5 DE-627 ger DE-627 rakwb rus TP248.13-248.65 E. A. Kuzminova verfasserin aut Test system for the detection of binding antibodies to interferon beta-1a for clinical use 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Test system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The applicability of the mentioned test system has been approved for the use in clinical studies for the evaluation of interferon beta-1a immunogenicity (pegylated and non-pegylated forms). интерферон бета 1а иммуногенность твердофазный иммуноферментный анализ (ифа) связывающие антитела (сат) антитела к препарату рассеянный склероз биоаналитические методы исследования клинические исследования interferon beta-1a immunogenicity enzyme linked immunosorbent assay (elisa) binding antibodies (bab) anti-drug antibodies (adas) multiple sclerosis (ms) bioanalytical methods clinical studies Biotechnology Medicine R T. Yu. Ostroukhova verfasserin aut A. V. Grachev verfasserin aut E. L. Morozova verfasserin aut In Биопрепараты: Профилактика, диагностика, лечение Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2018 16(2018), 3, Seite 182-188 (DE-627)1760620254 26191156 nnns volume:16 year:2018 number:3 pages:182-188 https://doaj.org/article/d5d68f37f91240af8fccdb7b5e3909e5 kostenfrei https://www.biopreparations.ru/jour/article/view/63 kostenfrei https://doaj.org/toc/2221-996X Journal toc kostenfrei https://doaj.org/toc/2619-1156 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 16 2018 3 182-188
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allfieldsGer	(DE-627)DOAJ004486757 (DE-599)DOAJd5d68f37f91240af8fccdb7b5e3909e5 DE-627 ger DE-627 rakwb rus TP248.13-248.65 E. A. Kuzminova verfasserin aut Test system for the detection of binding antibodies to interferon beta-1a for clinical use 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Test system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The applicability of the mentioned test system has been approved for the use in clinical studies for the evaluation of interferon beta-1a immunogenicity (pegylated and non-pegylated forms). интерферон бета 1а иммуногенность твердофазный иммуноферментный анализ (ифа) связывающие антитела (сат) антитела к препарату рассеянный склероз биоаналитические методы исследования клинические исследования interferon beta-1a immunogenicity enzyme linked immunosorbent assay (elisa) binding antibodies (bab) anti-drug antibodies (adas) multiple sclerosis (ms) bioanalytical methods clinical studies Biotechnology Medicine R T. Yu. Ostroukhova verfasserin aut A. V. Grachev verfasserin aut E. L. Morozova verfasserin aut In Биопрепараты: Профилактика, диагностика, лечение Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2018 16(2018), 3, Seite 182-188 (DE-627)1760620254 26191156 nnns volume:16 year:2018 number:3 pages:182-188 https://doaj.org/article/d5d68f37f91240af8fccdb7b5e3909e5 kostenfrei https://www.biopreparations.ru/jour/article/view/63 kostenfrei https://doaj.org/toc/2221-996X Journal toc kostenfrei https://doaj.org/toc/2619-1156 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 16 2018 3 182-188
allfieldsSound	(DE-627)DOAJ004486757 (DE-599)DOAJd5d68f37f91240af8fccdb7b5e3909e5 DE-627 ger DE-627 rakwb rus TP248.13-248.65 E. A. Kuzminova verfasserin aut Test system for the detection of binding antibodies to interferon beta-1a for clinical use 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Test system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The applicability of the mentioned test system has been approved for the use in clinical studies for the evaluation of interferon beta-1a immunogenicity (pegylated and non-pegylated forms). интерферон бета 1а иммуногенность твердофазный иммуноферментный анализ (ифа) связывающие антитела (сат) антитела к препарату рассеянный склероз биоаналитические методы исследования клинические исследования interferon beta-1a immunogenicity enzyme linked immunosorbent assay (elisa) binding antibodies (bab) anti-drug antibodies (adas) multiple sclerosis (ms) bioanalytical methods clinical studies Biotechnology Medicine R T. Yu. Ostroukhova verfasserin aut A. V. Grachev verfasserin aut E. L. Morozova verfasserin aut In Биопрепараты: Профилактика, диагностика, лечение Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2018 16(2018), 3, Seite 182-188 (DE-627)1760620254 26191156 nnns volume:16 year:2018 number:3 pages:182-188 https://doaj.org/article/d5d68f37f91240af8fccdb7b5e3909e5 kostenfrei https://www.biopreparations.ru/jour/article/view/63 kostenfrei https://doaj.org/toc/2221-996X Journal toc kostenfrei https://doaj.org/toc/2619-1156 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 16 2018 3 182-188
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author	E. A. Kuzminova
spellingShingle	E. A. Kuzminova misc TP248.13-248.65 misc интерферон бета 1а misc иммуногенность misc твердофазный иммуноферментный анализ (ифа) misc связывающие антитела (сат) misc антитела к препарату misc рассеянный склероз misc биоаналитические методы исследования misc клинические исследования misc interferon beta-1a misc immunogenicity misc enzyme linked immunosorbent assay (elisa) misc binding antibodies (bab) misc anti-drug antibodies (adas) misc multiple sclerosis (ms) misc bioanalytical methods misc clinical studies misc Biotechnology misc Medicine misc R Test system for the detection of binding antibodies to interferon beta-1a for clinical use
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topic_title	TP248.13-248.65 Test system for the detection of binding antibodies to interferon beta-1a for clinical use интерферон бета 1а иммуногенность твердофазный иммуноферментный анализ (ифа) связывающие антитела (сат) антитела к препарату рассеянный склероз биоаналитические методы исследования клинические исследования interferon beta-1a immunogenicity enzyme linked immunosorbent assay (elisa) binding antibodies (bab) anti-drug antibodies (adas) multiple sclerosis (ms) bioanalytical methods clinical studies
topic	misc TP248.13-248.65 misc интерферон бета 1а misc иммуногенность misc твердофазный иммуноферментный анализ (ифа) misc связывающие антитела (сат) misc антитела к препарату misc рассеянный склероз misc биоаналитические методы исследования misc клинические исследования misc interferon beta-1a misc immunogenicity misc enzyme linked immunosorbent assay (elisa) misc binding antibodies (bab) misc anti-drug antibodies (adas) misc multiple sclerosis (ms) misc bioanalytical methods misc clinical studies misc Biotechnology misc Medicine misc R
topic_unstemmed	misc TP248.13-248.65 misc интерферон бета 1а misc иммуногенность misc твердофазный иммуноферментный анализ (ифа) misc связывающие антитела (сат) misc антитела к препарату misc рассеянный склероз misc биоаналитические методы исследования misc клинические исследования misc interferon beta-1a misc immunogenicity misc enzyme linked immunosorbent assay (elisa) misc binding antibodies (bab) misc anti-drug antibodies (adas) misc multiple sclerosis (ms) misc bioanalytical methods misc clinical studies misc Biotechnology misc Medicine misc R
topic_browse	misc TP248.13-248.65 misc интерферон бета 1а misc иммуногенность misc твердофазный иммуноферментный анализ (ифа) misc связывающие антитела (сат) misc антитела к препарату misc рассеянный склероз misc биоаналитические методы исследования misc клинические исследования misc interferon beta-1a misc immunogenicity misc enzyme linked immunosorbent assay (elisa) misc binding antibodies (bab) misc anti-drug antibodies (adas) misc multiple sclerosis (ms) misc bioanalytical methods misc clinical studies misc Biotechnology misc Medicine misc R
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title	Test system for the detection of binding antibodies to interferon beta-1a for clinical use
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title_full	Test system for the detection of binding antibodies to interferon beta-1a for clinical use
author_sort	E. A. Kuzminova
journal	Биопрепараты: Профилактика, диагностика, лечение
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author_browse	E. A. Kuzminova T. Yu. Ostroukhova A. V. Grachev E. L. Morozova
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title_sort	test system for the detection of binding antibodies to interferon beta-1a for clinical use
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title_auth	Test system for the detection of binding antibodies to interferon beta-1a for clinical use
abstract	Test system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The applicability of the mentioned test system has been approved for the use in clinical studies for the evaluation of interferon beta-1a immunogenicity (pegylated and non-pegylated forms).
abstractGer	Test system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The applicability of the mentioned test system has been approved for the use in clinical studies for the evaluation of interferon beta-1a immunogenicity (pegylated and non-pegylated forms).
abstract_unstemmed	Test system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The applicability of the mentioned test system has been approved for the use in clinical studies for the evaluation of interferon beta-1a immunogenicity (pegylated and non-pegylated forms).
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title_short	Test system for the detection of binding antibodies to interferon beta-1a for clinical use
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Yu. Ostroukhova</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">A. V. Grachev</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">E. L. Morozova</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">In</subfield><subfield code="t">Биопрепараты: Профилактика, диагностика, лечение</subfield><subfield code="d">Ministry of Health of the Russian Federation. 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Test system for the detection of binding antibodies to interferon beta-1a for clinical use

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