Scientific aspects of the development of the State Pharmacopoeia of Ukraine
| Autor: | A. I. Gryzodub |
|---|---|
| Jazyk: | ruština |
| Rok vydání: | 2018 |
| Předmět: |
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 Medicine (General) R5-920 |
| Zdroj: | Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 2, Pp 19-25 (2018) |
| Druh dokumentu: | article |
| ISSN: | 3034-3062 3034-3453 |
| Popis: | 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. |
| Databáze: | Directory of Open Access Journals |
| Externí odkaz: |
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