The development of the monographs for compoundED preparations for the state pharmacopoeia of Ukraine
At present, there are certain topical issues related to the development of the standards for preparation and quality control of compounded medicines, the elaboration of quality assurance system for compounded preparations under the state policy implementation principles. One of the appropriate solut...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | Russian |
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Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2018-02-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/85 |
| _version_ | 1826566775621287936 |
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| author | A. A. Zdoryk L. P. Savchenko V. A. Georgiyants A. I. Gryzodub |
| author_facet | A. A. Zdoryk L. P. Savchenko V. A. Georgiyants A. I. Gryzodub |
| author_sort | A. A. Zdoryk |
| collection | DOAJ |
| description | At present, there are certain topical issues related to the development of the standards for preparation and quality control of compounded medicines, the elaboration of quality assurance system for compounded preparations under the state policy implementation principles. One of the appropriate solutions is the introduction of general chapters and monographs to the State Pharmacopoeia. The structure of the Second Edition of the State Pharmacopoeia of Ukraine includes five general pharmacopoeia chapters for compounded preparations. The next work step is the development of the pharmacopoeia concept for the elaboration of pharmacopeia monographs for officinal prescriptions and their introduction to the national part of the pharmacopoeia. In order to fulfill the mentioned task, the approaches for assessing the quality of extemporaneous preparations should be approved, the quality control methods should be developed and validated, the validation of technological process should be performed, and the stability and the expiration dates should be examined. The algorithm and the stages of the elaboration of pharmacopeia monographs for compounded preparations are described in the article, the structure of monographs is proposed, the examples of monographs for intra pharmaceutical preparations and concentrated solutions are given. |
| first_indexed | 2024-03-07T19:18:12Z |
| format | Article |
| id | doaj.art-880487c6f677453d9ef49ae2e1f91f06 |
| institution | Directory Open Access Journal |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| last_indexed | 2025-03-14T10:57:01Z |
| publishDate | 2018-02-01 |
| publisher | Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) |
| record_format | Article |
| series | Регуляторные исследования и экспертиза лекарственных средств |
| spelling | doaj.art-880487c6f677453d9ef49ae2e1f91f062025-03-02T10:46:39ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-02-0103121583The development of the monographs for compoundED preparations for the state pharmacopoeia of UkraineA. A. Zdoryk0L. P. Savchenko1V. A. Georgiyants2A. I. Gryzodub3National University of PharmacyNational University of PharmacyNational University of PharmacyUkrainian Scientific Pharmacopoeial Center for Quality of MedicinesAt present, there are certain topical issues related to the development of the standards for preparation and quality control of compounded medicines, the elaboration of quality assurance system for compounded preparations under the state policy implementation principles. One of the appropriate solutions is the introduction of general chapters and monographs to the State Pharmacopoeia. The structure of the Second Edition of the State Pharmacopoeia of Ukraine includes five general pharmacopoeia chapters for compounded preparations. The next work step is the development of the pharmacopoeia concept for the elaboration of pharmacopeia monographs for officinal prescriptions and their introduction to the national part of the pharmacopoeia. In order to fulfill the mentioned task, the approaches for assessing the quality of extemporaneous preparations should be approved, the quality control methods should be developed and validated, the validation of technological process should be performed, and the stability and the expiration dates should be examined. The algorithm and the stages of the elaboration of pharmacopeia monographs for compounded preparations are described in the article, the structure of monographs is proposed, the examples of monographs for intra pharmaceutical preparations and concentrated solutions are given.https://www.vedomostincesmp.ru/jour/article/view/85лекарственные средства аптечного приготовлениястандартизацияпоказатели качествагосударственная фармакопея украинычастная фармакопейная статьяcompounded preparationsstandardizationspecificationsthe state pharmacopoeia of ukrainepharmacopeia monograph |
| spellingShingle | A. A. Zdoryk L. P. Savchenko V. A. Georgiyants A. I. Gryzodub The development of the monographs for compoundED preparations for the state pharmacopoeia of Ukraine Регуляторные исследования и экспертиза лекарственных средств лекарственные средства аптечного приготовления стандартизация показатели качества государственная фармакопея украины частная фармакопейная статья compounded preparations standardization specifications the state pharmacopoeia of ukraine pharmacopeia monograph |
| title | The development of the monographs for compoundED preparations for the state pharmacopoeia of Ukraine |
| title_full | The development of the monographs for compoundED preparations for the state pharmacopoeia of Ukraine |
| title_fullStr | The development of the monographs for compoundED preparations for the state pharmacopoeia of Ukraine |
| title_full_unstemmed | The development of the monographs for compoundED preparations for the state pharmacopoeia of Ukraine |
| title_short | The development of the monographs for compoundED preparations for the state pharmacopoeia of Ukraine |
| title_sort | development of the monographs for compounded preparations for the state pharmacopoeia of ukraine |
| topic | лекарственные средства аптечного приготовления стандартизация показатели качества государственная фармакопея украины частная фармакопейная статья compounded preparations standardization specifications the state pharmacopoeia of ukraine pharmacopeia monograph |
| url | https://www.vedomostincesmp.ru/jour/article/view/85 |
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