Considerations regarding demonstration of efficacy and safety of homeopathic medicines
The article analyses the regulatory and legal framework for medicines evaluation in the Russian Federation and abroad, as well as guidelines, scientific literature and practical experience to justify criteria for evaluation of efficacy and safety of homeopathic medicines. When selecting appropriate...
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| 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 |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/126 |
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| _version_ | 1849393922840723456 |
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| author | R. D. Syubaev N. M. Krutikova G. N. Engalycheva N. G. Olenina |
| author_facet | R. D. Syubaev N. M. Krutikova G. N. Engalycheva N. G. Olenina |
| author_sort | R. D. Syubaev |
| collection | DOAJ |
| description | The article analyses the regulatory and legal framework for medicines evaluation in the Russian Federation and abroad, as well as guidelines, scientific literature and practical experience to justify criteria for evaluation of efficacy and safety of homeopathic medicines. When selecting appropriate evaluation criteria the authors took into account specificity of homeopathic medicines composition and dosage form formulation, specific characteristics of pharmaceutical substances and therapeutic action, as well as known limitations on the use of standard test methods. The key criteria for homeopathic medicines evaluation are: compliance of the substance quality and the drug production technology with corresponding pharmacopoeial requirements, substantiation of the drug composition safety, and confirmation of the proposed efficacy and safety by the evidence-based pre-clinical and clinical programme. |
| format | Article |
| id | doaj-art-2a8adba5f274454599e5674707e3795a |
| institution | Kabale University |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| 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-2a8adba5f274454599e5674707e3795a2025-08-20T03:40:14ZrusFederal 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 средств3034-30623034-34532018-02-017298103124Considerations regarding demonstration of efficacy and safety of homeopathic medicinesR. D. Syubaev0N. M. Krutikova1G. N. Engalycheva2N. G. Olenina3Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe article analyses the regulatory and legal framework for medicines evaluation in the Russian Federation and abroad, as well as guidelines, scientific literature and practical experience to justify criteria for evaluation of efficacy and safety of homeopathic medicines. When selecting appropriate evaluation criteria the authors took into account specificity of homeopathic medicines composition and dosage form formulation, specific characteristics of pharmaceutical substances and therapeutic action, as well as known limitations on the use of standard test methods. The key criteria for homeopathic medicines evaluation are: compliance of the substance quality and the drug production technology with corresponding pharmacopoeial requirements, substantiation of the drug composition safety, and confirmation of the proposed efficacy and safety by the evidence-based pre-clinical and clinical programme.https://www.vedomostincesmp.ru/jour/article/view/126экспертиза лекарственных средствгомеопатические лекарственные препаратыэффективностьбезопасностькритерии оценкиmedicines quality evaluationhomeopathic medicinesefficacysafetyevaluation criteria |
| spellingShingle | R. D. Syubaev N. M. Krutikova G. N. Engalycheva N. G. Olenina Considerations regarding demonstration of efficacy and safety of homeopathic medicines Регуляторные исследования и экспертиза лекарственных средств экспертиза лекарственных средств гомеопатические лекарственные препараты эффективность безопасность критерии оценки medicines quality evaluation homeopathic medicines efficacy safety evaluation criteria |
| title | Considerations regarding demonstration of efficacy and safety of homeopathic medicines |
| title_full | Considerations regarding demonstration of efficacy and safety of homeopathic medicines |
| title_fullStr | Considerations regarding demonstration of efficacy and safety of homeopathic medicines |
| title_full_unstemmed | Considerations regarding demonstration of efficacy and safety of homeopathic medicines |
| title_short | Considerations regarding demonstration of efficacy and safety of homeopathic medicines |
| title_sort | considerations regarding demonstration of efficacy and safety of homeopathic medicines |
| topic | экспертиза лекарственных средств гомеопатические лекарственные препараты эффективность безопасность критерии оценки medicines quality evaluation homeopathic medicines efficacy safety evaluation criteria |
| url | https://www.vedomostincesmp.ru/jour/article/view/126 |
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