Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics
These recommendations present the specifics of laboratory testing and examination of regulatory documents. The recommendations include information about the basic principles of presentation of the quality assessment methods. The paper demonstrates the following: a general presentation scheme of regu...
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OOO “Vashe Tsifrovoe Izdatelstvo”
2018-02-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/45 |
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doaj-ad7affd70e394ab396317aa5ced842922021-07-28T14:04:07ZrusOOO “Vashe Tsifrovoe Izdatelstvo”Ведомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-010381243Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristicsO. B. Ustinnikova0O. B. Runova1E. V. Velichko2Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationThese recommendations present the specifics of laboratory testing and examination of regulatory documents. The recommendations include information about the basic principles of presentation of the quality assessment methods. The paper demonstrates the following: a general presentation scheme of regulatory documents sections with a detailed description of subsections structure, the peculiarities of presentation of the methods for evaluation of physicochemical quality characteristics of immunobiologicals and the typical mistakes made in the process of drafting regulatory documents.https://www.vedomostincesmp.ru/jour/article/view/45иммунобиологические лекарственные препаратылабораторная экспертизафизико-химические показателинормативная документацияизложение методикimmunobiological medicineslaboratory testingphysicochemical quality characteristicsregulatory documentationpresentation techniques |
| collection |
DOAJ |
| language |
Russian |
| format |
Article |
| sources |
DOAJ |
| author |
O. B. Ustinnikova O. B. Runova E. V. Velichko |
| spellingShingle |
O. B. Ustinnikova O. B. Runova E. V. Velichko Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics Ведомости Научного центра экспертизы средств медицинского применения иммунобиологические лекарственные препараты лабораторная экспертиза физико-химические показатели нормативная документация изложение методик immunobiological medicines laboratory testing physicochemical quality characteristics regulatory documentation presentation techniques |
| author_facet |
O. B. Ustinnikova O. B. Runova E. V. Velichko |
| author_sort |
O. B. Ustinnikova |
| title |
Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics |
| title_short |
Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics |
| title_full |
Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics |
| title_fullStr |
Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics |
| title_full_unstemmed |
Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics |
| title_sort |
recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics |
| publisher |
OOO “Vashe Tsifrovoe Izdatelstvo” |
| series |
Ведомости Научного центра экспертизы средств медицинского применения |
| issn |
1991-2919 2619-1172 |
| publishDate |
2018-02-01 |
| description |
These recommendations present the specifics of laboratory testing and examination of regulatory documents. The recommendations include information about the basic principles of presentation of the quality assessment methods. The paper demonstrates the following: a general presentation scheme of regulatory documents sections with a detailed description of subsections structure, the peculiarities of presentation of the methods for evaluation of physicochemical quality characteristics of immunobiologicals and the typical mistakes made in the process of drafting regulatory documents. |
| topic |
иммунобиологические лекарственные препараты лабораторная экспертиза физико-химические показатели нормативная документация изложение методик immunobiological medicines laboratory testing physicochemical quality characteristics regulatory documentation presentation techniques |
| url |
https://www.vedomostincesmp.ru/jour/article/view/45 |
| work_keys_str_mv |
AT obustinnikova recommendationsfordraftingregulatorydocumentsonimmunobiologicalmedicinesparticularlythesectiononphysicochemicalqualitycharacteristics AT obrunova recommendationsfordraftingregulatorydocumentsonimmunobiologicalmedicinesparticularlythesectiononphysicochemicalqualitycharacteristics AT evvelichko recommendationsfordraftingregulatorydocumentsonimmunobiologicalmedicinesparticularlythesectiononphysicochemicalqualitycharacteristics |
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1721268627584319488 |