The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products / Ведомости Научного центра экспертизы средств медицинского применения
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Применение альтернативного метода определения влажности в лекарственных растительных препаратах
No full textThe article compares two methods of loss on drying determination in herbal medicinal products: drying using an infrared thermographic moisture analyzer and drying carried out in a drying cabinet. Data obtained with the moisture analyzer were shown to be sufficient for determination of loss on drying in herbal medicinal products of different morphological groups and were generally consistent with the data obtained by the traditional pharmacopoeial method - drying in a drying cabinet. The article demonstrates the feasibility of performing loss on drying test using an infrared thermographic moisture analyzer.Проведена сравнительная оценка двух методов определения влажности в лекарственных растительных препаратах: высушивания с использованием термографического инфракрасного анализатора влажности и высушивания в сушильном шкафу. Показано, что при использовании анализатора влажности получены данные, позволяющие определить влажность в лекарственных растительных препаратах разных морфологических групп; результаты в основном согласуются с данными, полученными традиционным фармакопейным методом - методом высушивания с использованием сушильного шкафа. Обоснована целесообразность определения влажности в лекарственном растительном сырье с использованием термографического инфракрасного влагомера
Оценка влияния автоматизации на вариабельность результатов теста «Растворение» на примере лекарственного препарата «Бетагистина гидрохлорид таблетки 16 мг»
No full textThe article analyses the results of dissolution testing of Betahistine hydrochloride 16 mg tablets using both manual and automatic sampling. The analysis showed that the data obtained with manual sampling are statistically identical to those obtained with automatic sampling in terms of average values and variance (with significance level α = 0,05), which confirms that the automation of the dissolution test does not affect the variability of test results.В статье приведен анализ результатов теста «Растворение» на оборудовании с ручным и автоматическим отбором проб для препарата «Бетагистина гидрохлорид таблетки 16 мг». По результатам подсчетов установлено, что данные, полученные при проведении теста на ручной системе, и данные, полученные при проведении теста на автоматической системе, статистически тождественны по среднему значению и дисперсии (на уровне значимости α = 0,05), тем самым доказывая, что автоматизация теста «Растворение» не влияет на вариабельность результатов испытания
АНАЛИЗ РЕЗУЛЬТАТОВ ИСПОЛЬЗОВАНИЯ АМИНО-, АМИДНЫХ И НИТРИЛЬНЫХ СОРБЕНТОВ В ЖИДКОСТНОЙ ХРОМАТОГРАФИИ ГИДРОФИЛЬНЫХ ВЗАИМОДЕЙСТВИЙ
Get PDFThe article summarises the results of studies of hydrophilic interaction liquid chromatography performed from 2013 until 2017. The analysis of results obtained during separation of a number of model mixtures of compounds having different nature helped to compare the characteristics of columns packed with amino, amide and nitrile sorbents. It was demonstrated that columns packed with amino sorbents could be used for the analysis of both hydrophilic compounds and some hydrophobic compounds containing acidic (4-hydroxybenzoic acid) and potentially acidic groups (nitro groups of nitro compounds; phenolic hydroxyl groups of butylhydroxyanisole isomers and parabens). It was discovered that chromatographic columns packed with nitrile and amide sorbents have common properties and can be used for the analysis of hydrophilic compounds (hydroxycarbamide) and platinum coordination compounds, but cannot be used for the analysis of butylhydroxyanisole isomers, esters of p-hydroxybenzoic acid and nitrate esters of isosorbide. The article offers hypotheses about possible mechanisms of interaction between test substances and sorbents. It was concluded that the increase in the acetonitrile content in mobile phases, which increases the retention time of the test substances and results in better resolution between their peaks, illustrates the mechanism of hydrophilic interaction liquid chromatography
Фармакоэкономика ВИЧ-инфекции
Get PDFEver since the first registrations of HIV-infections at the territory of the Russian Federation there was started a great process on arrangement and, subsequently, development of anti-HIV system. It should be noted, that increase of HIV screening and number of patients on antiretroviral treatment are the most important features of the system. Nevertheless, experts note the continuing growth of the size of infected population and, that is more important, the escape of HIV-epidemics from the groups with risk behaviors to the general population, therefore it is necessary to further increase the effectiveness of activities against HIV-spreading. In particular, it is necessary to use more rational (in the context of both the effectiveness, safety and cost) in present settings medical technologies. Pharmacoeconomic analysis is an appropriate instrument for these challenges. However pharmacoeconomic analysis within HIV-infection, like within all other disease areas, has some planning and conducting specialties. We formulated some key aspects of pharmacoeconomic analysis within HIV-infection: need for modelling; use of several criteria (virological, immunological, clinical and epidemiological); consideration of adherence to the therapy; consideration of complications costs; consideration of indirect costs
Формирование концепции «автоматизированного рабочего места эксперта»
Get PDFOne of the principle ways of improving the process of the expert evaluation of medicines is the optimization of expert evaluation timing and creation the system, preventing the occurrence of errors. For this purpose the experts of the Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation are working on establishment of the concept of creating the information system that would meet all the requirements. The main objectives of the measures taken are the optimization of expert evaluations processes management, automation of manual operations associated with working activities of an expert, specific recommendations for the implementation of collection and storage of primary data, both obtained from analytical instruments and introduced by experts. The authors have considered general principles of «automated expert workplace» concept, the challenge of information technologies elaboration in the sphere of drug development, evaluation and circulation. The role of information systems at each stage of drug life cycle has been defined. A number of optimum approaches to organizing automated expert workplace have been identified
РЕГУЛЯТОРНЫЕ И МЕТОДИЧЕСКИЕ АСПЕКТЫ ИЗУЧЕНИЯ АЛЛЕРГИЗИРУЮЩИХ СВОЙСТВ НОВЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ НА ЭТАПЕ ДОКЛИНИЧЕСКИХ ИССЛЕДОВАНИЙ
Get PDFThe assessment of allergic risk at the preclinical stage of drug development has been a debatable issue due to the integration of national requirements for medicines authorisation with those of the Eurasian Economic Union (EAEU). The article summarises mechanisms and factors involved in the development of drug hypersensitivity, as well as the main national and foreign regulatory requirements. It also cites the results of allergic risk assessment studies involving standard guinea pig tests, such as systemic anaphylactic reactions and active cutaneous anaphylaxis, for a number of medicines with the molecular weight of the active substance of more than 1000 Da and less than 1000 Da. Data analysis confirms that the number of positive reactions for high molecular weight compounds (>1000 Da) is significantly higher than the number of positive reactions for low molecular weight compounds (<1000 Da). There were some false-positive results detected. The results of foreign studies confirm the lack of correlation between the experimental data obtained in similar tests in guinea pigs and the clinical data. Thus, standard tests in guinea pigs cannot adequately predict the risk of immediate hypersensitivity reactions to new medicines in clinical practice. Negative or positive results should not be regarded as confirmation of potential absence or presence of anaphylactic reactions in clinical practice
Фармакогенетическое тестирование в оптимизации терапии сахарного диабета 2 типа препаратами сульфонилмочевины
No full textThe article analyses scientific literature on the use of pharmacogenetic testing to optimize sulfonylurea treatment of patients with type 2 diabetes. It describes characteristics of modern sulfonylurea drugs used in the treatment of type 2 diabetes, including their mode of action, and the frequency of associated hypoglycaemia events. The authors analysed the main pharmacokinetic parameters of sulfonylureas (bioavailability, protein binding, metabolites, elimination, etc.), and adverse reactions associated with these drugs. Based on integrated data on Cytochrome P450 isoenzymes role in sulfonylureas metabolism, and determination of the role played by polymorphism of the gene encoding this fragment, the authors demonstrated the usefulness of pharmacogenetic testing combined with phenotypic (losartan) testing in the treatment of patients with type 2 diabetes.Проведен анализ данных научной литературы по применению фармакогенетических исследований в оптимизации лечения пациентов с сахарным диабетом 2 типа препаратами сульфонилмочевины (ПСМ). Представлена характеристика современных гипогликемических ПСМ, используемых в терапии сахарного диабета 2 типа, включая описание механизма их действия, а также данные о частоте развития гипогликемий при этом заболевании. Проанализированы основные фармакокинетические показатели ПСМ (биодоступность, связь с белком, метаболиты, элиминация и др.), нежелательные реакции, вызванные данными препаратами. На основе систематизированных данных об участии изоферментов цитохрома Р450 в метаболизме ПСМ, выявлении роли полиморфизма гена, кодирующего данный фермент, продемонстрирована целесообразность проведения фармакогенетического тестирования при лечении пациентов с сахарным диабетом 2 типа ПСМ в комплексе с использованием методики фенотипирования (лозартанового теста)
Фармакоэкономика спастических форм детского церебрального паралича
Get PDFCerebral palsy (CP) is one of the most widespread and socially significant neurological diseases that affect both various aspects of physical and psychoverbal development of children since birth and stages of their personal development and adaptation in society. Over the last years there has been an increase in the number of children with disabilities in Russia, and it should be noted that CP ranks first among neurological disabilities in children. Given the lifetime course of this disease, CP acquires a huge medical and socioeconomic relevance. In particular, it is necessary to use the most efficient medical technologies (from the point of view of both efficacy, safety and costs). Pharmacoeconomic analysis is the most suitable tool for solving these tasks. However, when performing pharmacoeconomic analysis in the field of cerebral palsy, as well as in any other disease area, it is obligatory to take into account certain peculiarities at the planning and implementation stages. The authors of the article have identified specific features of pharmacoeconomic analysis methods based on assessment of health technologies related to cerebral palsy
Валидация фармацевтических информационных систем: общие положения
Get PDFNternational practices comprise integrated common approaches to validation of information systems, used in pharmaceutical industry by various organizations and that affect the results of their work. The purpose ofvalidation is to assure that the results, obtained with the help of an information system are reliable. Validated system ensures accurate results and reduces the risk of errors. The article describes basic principles of the validation of pharmaceutical information systems. The principles are constituted on the basis of international requirements of OMCL system and international standards of ISO system. The article provides the classification information systems used in pharmaceutical organizations. It also describes basic concepts of validation of information systems, such as version management, validation testing, change management, requirement consideration. Basic requirements for application of risk management system to creation of concept devoted to pharmaceutical information system validation are also provided.В международной практике созданы единые общие подходы к валидации информационных систем, которые используются в организациях фармацевтической отрасли и оказывают влияние на результат их работы. Целью валидации является обеспечение гарантий, что полученные при участии информационной системы результаты достоверны. Валидированная система обеспечивает точные результаты и снижает риск возникновения ошибок. Авторами изложены базовые принципы проведения валидации фармацевтических информационных систем. Принципы оформлены на основе международных требований системы OMCL и международных стандартов системы ISO. Представлена классификация применяемых в фармацевтических организациях информационных систем. Приведены основные понятия системы валидации информационных систем: управление версиями, валидационное тестирование, управление изменениями, учет требований. Приведены базовые требования к применению системы управления рисками для формирования концепции проведения валидации фармацевтических информационных систем
Основные требования к биологическим показателям при оценке качества лекарственных средств. Возможности валидации биологических методов контроля
No full textDrug quality evaluation and control involve extensive use of biological methods in addition to chemical, physico-chemical and microbiological ones in order to ensure drug identity, purity and safety. Basic requirements for biological testing criteria are stated in the State Pharmacopoeia of the Russian Federation, however some aspects of testing are not described in sufficient detail and depend on the nature of a medicine to be tested. The present article describes basic requirements for introducing «Bacterial endotoxins» and «Abnormal toxicity» parameters to normative documentation. It also outlines basic aspects of test conditions validation and determination of an adequate level of drug quality standards.В рамках экспертизы и контроля качества лекарственных средств наряду с химическими, физико-химическими, биохимическими и микробиологическими методами широко применяются биологические методы подтверждения подлинности, чистоты и безопасности лекарственных средств . Основные требования к выполнению испытаний по биологическим показателям утверждены Государственной фармакопеей Российской Федерации, однако некоторые аспекты выполнения тестирования описаны недостаточно и напрямую зависят от природы испытуемого лекарственного средства. В данной статье описаны основные требования к введению в нормативную документацию биологических показателей: «Бактериальные эндотоксины» и «Аномальная токсичность», а также приведены основные аспекты валидации условий испытания и выбора надежного уровня норм качества лекарственного средства