The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products / Ведомости Научного центра экспертизы средств медицинского применения
Not a member yet
395 research outputs found
Sort by
Колоночная хроматография в очистке образца генотоксичной примеси субстанции иматиниба мезилат
No full textThe article describes a simple method for purifying N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine for further use as a standard for quantitative determination of genotoxic impurities substance imatinib mesylate. Experimentally proved choice of sorbent used for purification of N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine. The advantage of column chromatography on neutral alumina prior to crystallization methods presented in the literature. Comparative chromatographic and spectral characteristics of N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine before and after purification. NMR spectroscopy evaluated quantitative content of the target substance in the purified sample.В статье показан простой способ очистки N-(5-амино-2-метилфенил)-4-(3-пиридил)-2-пиримидинамина для дальнейшего использования его в качестве стандарта при количественном определении генотоксичной примеси субстанции иматиниба мезилат. Экспериментально обоснован выбор сорбента, применяемого для очистки N-(5-амино-2-метилфенил)-4-(3-пиридил)-2-пиримидинамина. Показано преимущество колоночной хроматографии на нейтральном оксиде алюминия перед кристаллизационными методами, представленными в литературных источниках. Приведены сравнительные хроматографические и спектральные характеристики N-(5-амино-2-метилфенил)-4-(3-пиридил)-2-пиримидинамина до и после очистки. Методом ЯМР спектроскопии проведена оценка количественного содержания целевого вещества в очищенном образце
Критерии оценки когнитивных нарушений в клинических исследованиях
Get PDFNeuropsychological research methods are used to evaluate cognitive functions (CF). Tests used in clinical neuropsychology, in most cases, describe one or more aspects of cognitive domains that are theoretical «constructs» in which several cognitive processes are involved. Neuropsychological tests measure CFs regardless of the medical condition of the test subject. This allows for determination of even minor changes in CFs, including in clinical trials, which is of fundamental importance in studying the efficacy and safety of a given therapy. This article deals with specific aspects of using neuropsychological and screening testing of cognitive functions in individual domains on the basis of foreign experience. It discusses the criteria for selection and application of individual tools, their features, and choice of criteria for evaluating the results of testing in clinical studies in cases of CFs deterioration in various medical conditions accompanied by cognitive impairment. When planning clinical trials, it should also be taken into account that mixed anxiety-depressive disorders are likely to cause forgetfulness, and this calls for differential diagnosis and should be registered in clinical research protocols. The use of subscales and combinations of components of different tools are encouraged based on the objectives of the clinical study, and the tools of neuropsychological research and cognitive function assessment should be validated taking into account the specificity and sensitivity of the method, using statistical analysis methods for specific purposes and tasks. Such a multifaceted approach to the study of cognitive impairments will significantly increase the level of clinical trials conducted and, consequently, will make it possible to put up for sale efficacious and safe medicines for the treatment of cognitive impairment
ОСОБЕННОСТИ ЭКСПЕРТИЗЫ «ПОЛЬЗА/РИСК» ЛЕКАРСТВЕННЫХ РАСТИТЕЛЬНЫХ ПРЕПАРАТОВ: АНАЛИЗ РЕГИСТРАЦИОННЫХ ДОСЬЕ
Get PDFThe use of medicinal plants for therapeutic purposes (herbal medicine) is still popular nowadays. The aim of the present paper was to analyse registration dossiers for herbal medicines submitted for expert evaluation in accordance with the current national legal requirements for dossier compilation and methodological approaches to the examination of the benefit-risk ratio of herbal medicinal products. The article describes specific features of the preclinical and clinical sections of the common technical document for herbal medicinal products. The article also considers current national requirements for safety and efficacy evaluation of herbal medicinal products. It analyses specific aspects of preclinical (toxicological, pharmacokinetic and pharmacological) and clinical trials of medicines. Based on the results of the analysis the authors elucidate the main mistakes in the preparation of the necessary documents for registration dossiers for herbal medicinal products, namely: lack of complete information on the preclinical toxicological study of the product; inconsistencies in the product composition as specified in different documents; lack of statistical analysis of the results of studies; errors in draft patient information leaflets for herbal medicinal products. The materials presented in the article are high on the agenda and will help applicants properly compile registration dossiers for herbal medicinal products
Национальные особенности доклинических исследований и использования лабораторных животных в России: проблемы и перспективы
Get PDFThe analysis of the international experience in conducting preclinical studies and application of the principle of good laboratory practice was made. The issues associated with the use of laboratory animals for scientific purposes in Russia and abroad were discussed. The prospects of improvement of legislative base of the Russian Federation in the field of preclinical studies with the application of the principle of good laboratory practice and use of laboratory animals for scientific purposes were identified.Проведен анализ международного опыта организации проведения доклинических исследований и применения принципом надлежащей лабораторной практики. Обсуждены вопросы, связанные с использованием лабораторных животных в научных целях в РФ и за рубежом. Определены перспективы совершенствования законодательной базы РФ в области организации проведения доклинических исследований с применением принципом надлежащей лабораторной практики, а также использования лабораторных животных в научных целях
К вопросу оценки качества консервантов, используемых в современной практике производства иммунобиологических лекарственных препаратов
Get PDFThe analysis of national and foreign normative documents regulating modern requirements for preservative quality assessment has been performed. The need for elaboration of modern requirements for quality assessment and standardization of preservatives used in the production of immunobiological preparation in accordance with the good manufacturing and laboratory practice (GMP and GLP) has been justified. The conducted analysis has shown that the most common preservatives in immunobiological preparations are thiomersal, phenol and formaldehyde. The requirements for these preservatives have been elaborated and systematized. International and national assay methods and requirements for thiomersal, phenol, formaldehyde, have been characterized. The results of the studies have been used in elaboration of general chapters related to the assay of thiomersal, phenol and formaldehyde in immunobiological preparations. The projects of general chapters have been approved the minutes of the Board of the Ministry of Health of the Russian Federation on the State Pharmacopoeia and proposed for inclusion in the State Pharmacopoeia of the Russian Federation XIII edition. The constant increase in the range of immunobiological preparations shows the need for further research of preservatives as a part of their content, as well as for studying their properties, mechanism of action and combinations with other preservatives
Алгоритм действий при определении стерильности антибиотиков-карбапенемов
No full textThe article proposes a plan of action for assessing effectiveness and reliability of sterility testing in terms of neutralization of antimicrobial activity of residual amounts of antibiotics remaining on the membrane filters during the analysis. It was demonstrated that the proposed plan of action helps to select appropriate test conditions that rule out the possibility of obtaining false negative results for antibiotics with high biological activity that are capable of sticking to membrane filters. The article demonstrates the need for a stepwise experimental selection of test conditions using different test microorganisms in order to determine a combination of several methods for neutralization of residual amounts of antibiotics which helps to reduce costs, given that satisfactory results may be obtained at any stage depending on the nature of an antibiotic drug. The article explicitly substantiates all stages involved in determination of the completeness of membrane filters cleaning from residual amounts of antibiotics using the example of meropenem. Based on results of experiments test conditions were selected for meropenem products that ensured reliable results of sterility testing
Основные проблемы экспертизы качества фармацевтических субстанций (оценка количественного содержания)
No full textCommon topical issues of the quality assessment of pharmaceutical substances in terms of «Assay», are related to the compliance of actual test results to assay requirements as well as to the proper elaboration of normative documents (completeness, accuracy of the descriptions of analytical methods) and the appropriate test conditions validation with the materials in the scope of the mentioned regulatory documents. It was shown that an objective assessment of the quantitative content of an active ingredient in pharmaceutical substance of synthetic or mineral origin depends largely on the choice of the analytical method, use of the appropriate techniques considering the materials included in the monographs of the State Pharmacopoeia the Russian Federation and leading foreign pharmacopoeias.Общие проблемные вопросы, возникающие при экспертизе качества фармацевтических субстанций по показателю «Количественное определение», связаны с соответствием фактически полученных величин предусмотренным нормам количественного содержания, а также уровнем подготовки представленных нормативных документов (полнота, правильность изложения методик анализа) и соответствием условий проведения испытаний с валидационными материалами по данному разделу нормативной документации. Показано, что объективность оценки количественного содержания действующего вещества в фармацевтической субстанции синтетического или минерального происхождения во многом определяется выбором метода анализа, приведением соответствующих методик с учетом материалов, включенных в фармакопейные статьи Государственной фармакопеи Российской Федерации и монографии ведущих зарубежных фармакопей
Использование метода ЯМР-спектроскопии в фармакопейном анализе
No full textThe article illustrates the prospects of using nuclear magnetic resonance spectroscopy for complex, fast and reliable determination of key quality attributes of drug substances while performing pharmacopoeial analysis.Показана возможность применения метода спектроскопии мультиядерного магнитного резонанса для комплексного, экспрессного и надежного определения основных показателей качества лекарственных субстанций при проведении фармакопейного анализа