Scientific aspects of the development of the State Pharmacopoeia of Ukraine
The development of the State Pharmacopoeia of Ukraine (SPU) is based on the following principles: harmonization with the European Pharmacopoeia (EP); consideration of national specificity, self-sufficiency, National System of Pharmacopoeial Reference Standards (PhRS), feedback from users. For implem...
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Online Access: | https://www.vedomostincesmp.ru/jour/article/view/74 |
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doaj-3363a4d8a7a746e38fe1a2f06f05fb032021-07-28T14:04:07ZrusOOO “Vashe Tsifrovoe Izdatelstvo”Ведомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-0102192572Scientific aspects of the development of the State Pharmacopoeia of UkraineA. I. Gryzodub0Ukrainian Scientific Pharmacopoeial Center for Quality of MedicinesThe development of the State Pharmacopoeia of Ukraine (SPU) is based on the following principles: harmonization with the European Pharmacopoeia (EP); consideration of national specificity, self-sufficiency, National System of Pharmacopoeial Reference Standards (PhRS), feedback from users. For implementing the mentioned principles 4 main scientific areas of activity have been developed: proper elaboration of SPU texts, the National System of the PhRS, Proficiency Testing Scheme for medicines control laboratories (PTS), metrological support (in particular the validation of analytical procedures). The specificity of developing texts for SPU 1 (2001) and 2 editions (2016) have been analyzed for the following sections: general chapters, monographs for pharmaceutical substances, finished drug products, herbal medicinal products, compounded preparations, etc. The concept of further development of SPU has also been discussed.https://www.vedomostincesmp.ru/jour/article/view/74государственная фармакопея украинылекарственные средствафармакопейные стандартные образцыпрограммы профессионального тестирования лабораторийметрологическое обеспечениеобщие и частные фармакопейные статьиstate pharmacopoeia of ukrainemedicinespharmacopoeial reference standardsprofessional testing schemesmetrological supportgeneral chapters and specific monographs |
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DOAJ |
language |
Russian |
format |
Article |
sources |
DOAJ |
author |
A. I. Gryzodub |
spellingShingle |
A. I. Gryzodub Scientific aspects of the development of the State Pharmacopoeia of Ukraine Ведомости Научного центра экспертизы средств медицинского применения государственная фармакопея украины лекарственные средства фармакопейные стандартные образцы программы профессионального тестирования лабораторий метрологическое обеспечение общие и частные фармакопейные статьи state pharmacopoeia of ukraine medicines pharmacopoeial reference standards professional testing schemes metrological support general chapters and specific monographs |
author_facet |
A. I. Gryzodub |
author_sort |
A. I. Gryzodub |
title |
Scientific aspects of the development of the State Pharmacopoeia of Ukraine |
title_short |
Scientific aspects of the development of the State Pharmacopoeia of Ukraine |
title_full |
Scientific aspects of the development of the State Pharmacopoeia of Ukraine |
title_fullStr |
Scientific aspects of the development of the State Pharmacopoeia of Ukraine |
title_full_unstemmed |
Scientific aspects of the development of the State Pharmacopoeia of Ukraine |
title_sort |
scientific aspects of the development of the state pharmacopoeia of ukraine |
publisher |
OOO “Vashe Tsifrovoe Izdatelstvo” |
series |
Ведомости Научного центра экспертизы средств медицинского применения |
issn |
1991-2919 2619-1172 |
publishDate |
2018-02-01 |
description |
The development of the State Pharmacopoeia of Ukraine (SPU) is based on the following principles: harmonization with the European Pharmacopoeia (EP); consideration of national specificity, self-sufficiency, National System of Pharmacopoeial Reference Standards (PhRS), feedback from users. For implementing the mentioned principles 4 main scientific areas of activity have been developed: proper elaboration of SPU texts, the National System of the PhRS, Proficiency Testing Scheme for medicines control laboratories (PTS), metrological support (in particular the validation of analytical procedures). The specificity of developing texts for SPU 1 (2001) and 2 editions (2016) have been analyzed for the following sections: general chapters, monographs for pharmaceutical substances, finished drug products, herbal medicinal products, compounded preparations, etc. The concept of further development of SPU has also been discussed. |
topic |
государственная фармакопея украины лекарственные средства фармакопейные стандартные образцы программы профессионального тестирования лабораторий метрологическое обеспечение общие и частные фармакопейные статьи state pharmacopoeia of ukraine medicines pharmacopoeial reference standards professional testing schemes metrological support general chapters and specific monographs |
url |
https://www.vedomostincesmp.ru/jour/article/view/74 |
work_keys_str_mv |
AT aigryzodub scientificaspectsofthedevelopmentofthestatepharmacopoeiaofukraine |
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1721268569567657984 |