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
О допустимых значениях порога игнорирования примесей и отношения сигнал/шум при проверке чувствительности хроматографической системы
No full textThe article provides answers to urgent questions relating to the acceptable values of disregard limits for impurities and signal-to-noise ratio ( S / N ) when checking the sensitivity of the chromatographic system. It gives recommendations on the «typical» and maximum acceptable values of disregard limits for impurities. The article also demonstrates that the requirement of S / N ≥ 10 can be unnecessarily rigid in some cases: there could be found convincing arguments justifying a smaller S / N value for the sensitivity solution, for example, in cases when an identified impurity is determined by a specific procedure and the impurity peak appears before the peak of the main substance.Рассмотрены актуальные вопросы, связанные с допустимыми значениями порога игнорирования примесей и отношения сигнал/шум при проверке чувствительности хроматографической системы. Даны рекомендации, в том числе по «типичным» и максимально допустимым значениям порога игнорирования примесей. Показано, что требование, согласно которому отношение сигнал/шум должно быть не менее 10, в некоторых случаях является неоправданно жестким: могут иметься достаточно весомые доводы для обоснования меньшего значения отношения сигнал/шум для раствора для проверки чувствительности хроматографической системы, например, в случае идентифицированных примесей, определяемых по отдельной методике, когда пик примеси выходит до пика основного вещества
Научные аспекты разработки Государственной фармакопеи Украины
No full textThe 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.Разработка Государственной фармакопеи Украины основана на следующих принципах: гармонизация с Европейской фармакопеей, учет национальной специфики, самодостаточность, Национальная система фармакопейных стандартных образцов, обратная связь с пользователями. Для реализации этих принципов развиваются 4 основные научные направления: разработка собственно текстов Государственной фармакопеи Украины, Национальная система фармакопейных стандартных образцов, Программы профессионального тестирования лабораторий контроля качества лекарственных средств, метрологическое обеспечение (в частности, валидация аналитических методик). Рассмотрена специфика разработки текстов Государственной фармакопеи Украины I издания (2001 г.) и II издания (2016 г.): общих статей, монографий на субстанции, готовые лекарственные средства, лекарственное растительное сырье, экстемпоральные препараты и т.д. Обсуждается также концепция дальнейшего развития Государственной фармакопеи Украины
МЕТОДОЛОГИЧЕСКИЙ ПОДХОД К ПЛАНИРОВАНИЮ ЭКСПЕРИМЕНТА ПРИ ВЫБОРЕ КАЧЕСТВЕННЫХ РЕАКЦИЙ ДЛЯ ПОДТВЕРЖДЕНИЯ ПОДЛИННОСТИ КОМПОНЕНТОВ ЛЕКАРСТВЕННОГО СРЕДСТВА (НА ПРИМЕРЕ АСКОРБИНОВОЙ КИСЛОТЫ)
Get PDFИНФОРМАЦИОННАЯ СИСТЕМА ЭКСПЕРТНОЙ ОЦЕНКИ ПАРАМЕТРОВ ВЗАИМОЗАМЕНЯЕМОСТИ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ
Get PDFThe article dwells upon the development and implementation of a computerised information system for automation of expert work related to evaluation of medicines interchangeability parameters. The article analyses the results of application of a process-oriented approach to the development and implementation of an interchangeability evaluation algorithm in an expert institution. The article suggests step-by-step solutions for the development of an information system that will make it possible to automate standard operating procedures and help substantiate expert conclusions. The article provides basic legal and regulatory as well as scientific and technological information necessary for the creation of an information systems project for the development of a single intranet environment of an expert institution ensuring the automation of all key technological processes that rest upon single systematic approaches and principles. It was demonstrated that introduction of the designed information system in the institution ensures efficient implementation of standard operating procedures when assessing medicines interchangeability
Типовые инструкции по медицинскому применению взаимозаменяемых лекарственных препаратов: анализ современных документов, регулирующих их подготовку
No full textThe article presents a review of modern regulatory and legal framework and draft regulatory documents on circulation of interchangeable drugs with regard to standard instructions for medical use. The analysis included more than 70 documents. There are two slightly different notions in this field: a generic drug and an interchangeable drug. A generic drug is not necessarily an interchangeable drug. The interchangeability of a drug is determined during pre-marketing evaluation. Some differences concerning normative requirements to the content of standard instructions for interchangeable drugs have been observed when comparing the regulatory framework of Russia, CIS countries and the EU. It is necessary to look not only at bioequivalence as an equivalent of interchangeability, but also take into account characteristics of excipients, and therapeutic equivalence based on preclinical and clinical trial results. The analysis of differences in regulatory documents can form the basis for further harmonization of requirements to instructions for medical use of interchangeable drugs
НАДЛЕЖАЩАЯ ДИСТРИБЬЮТОРСКАЯ ПРАКТИКА: МОДЕРНИЗАЦИЯ СИСТЕМЫ КАЧЕСТВА ДИСТРИБЬЮЦИИ ЛЕКАРСТВЕННЫХ СРЕДСТВ В РОССИИ
Get PDFThe article describes the main stages of introduction of the Good Distribution Practice (GDP) in Russia following the adoption of new laws making it mandatory for wholesalers to comply with requirements for storage and transportation of medicinal products. The article compares the regulatory requirements of the European Union, Eurasian Economic Commission and the Russian Federation for GDP system development by entities involved in medicines circulation. It highlights the main activities that help a wholesaler create an efficient GDP system. The key role in the implementation of GDP principles is played by the director of the company and the employee in charge. The article analyses the risk-oriented approach that the Federal Service for Surveillance in Healthcare relies upon when supervising wholesalers of medicinal products. It was demonstrated that the compliance of a product with efficacy and safety criteria can only be assured if GDP standards are met
Возможности применения адаптивного дизайна в клинических исследованиях препаратов «next-in-class»
No full textThe article investigates the possibility of streamlining the methodology of clinical studies of next-in-class drugs by implementing an adaptive design. Next-in-class drugs are original drugs with known biological targets, similar in structure and mode of action to already existing well-established innovative products. The results of phase II-III clinical trials are illustrated by three investigational products of different pharmacological classes, including a DPP-4 inhibitor (Diabetes mellitus type 2), factor Xa inhibitor (VTE prevention in orthopedic surgery), and NNRTI (HIV). A two-stage «seamless» adaptive design was developed for the clinical trials. In all the three studies the non-inferiority hypothesis was tested versus the standards of care. The adaptive design in DPP-4 inhibitor study made it possible to assess the efficacy and safety of two consecutive treatment regiments (mono- and combination therapy). The optimal doses for factor Xa inhibitor and NNRTI were selected at Stage 1, and their efficacy and safety were tested at Stage 2. The non-inferiority vs. standards of care was successfully demonstrated for all investigational products. The introduction of the adaptive design resulted in the optimization of the clinical programs of the next-in-class drugs
ОПЫТ СОЗДАНИЯ ИНФОРМАЦИОННОЙ СИСТЕМЫ УПРАВЛЕНИЯ ДЕЯТЕЛЬНОСТЬЮ ИСПЫТАТЕЛЬНЫХ ЛАБОРАТОРИЙ ЭКСПЕРТНОГО УЧРЕЖДЕНИЯ В СФЕРЕ ОБРАЩЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ
Get PDFThis article describes the results of Laboratory Information Management System implementation in an expert institution dealing with medicines evaluation. The purpose of the study was to evaluate the feasibility of providing digital support to the laboratories of the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation and to assess the functionality of the information system in terms of coverage of functional capabilities of various classes of laboratory software. The implementation of laboratory automation systems is required by the current regulations and is in line with international approaches to organisation of the quality management. The information system implementation made it possible to computerize management of drug samples, distribution of assignments among responsible employees, storage and management of documents, and reporting of test results. It created opportunities for direct integration with laboratory equipment allowing for creation of analytical protocols without manual data transfer. The implemented solution meets all requirements and standards for the functional capabilities of laboratory information systems. A similar system could be used in chemical, pharmacological, medical and biochemical laboratories, its implementation will make it possible to meet both national and international standards. These innovations are part of the concept of CALS/PLM technologies integration into institutions management programmes
Внедрение эффективных систем управления качеством в организациях, проводящих доклинические и клинические исследования и осуществляющих фармаконадзор
No full textThe article analyses main quality assurance requirements for organizations that participate in preclinical and clinical trials and pharmacovigilance. It describes the key elements of the quality management system, provides practical advice on their implementation, and reviews the most common mistakes. The author draws attention to the necessity of implementing a holistic, risk-oriented process approach at all stages of drugs development, the importance of improving control over manufacture and circulation of investigational drugs, the need to make trial results available to general public and academic community and to apply the quality by design concept to preclinical and clinical trials in a similar way as it is now applied to drug manufacture.Представлены результаты анализа основных требований в области качества к организациям, участвующих в проведении доклинических и клинических исследований, фармаконадзоре. Описаны основные элементы системы менеджмента качества, даны практические рекомендации по их внедрению, проведен анализ часто встречающихся ошибок. Отмечена необходимость внедрения комплексного риск-ориентированного процессного подхода на всех этапах разработки лекарственных препаратов, усовершенствования процедуры по контролю за производством и обращением исследуемых препаратов, обеспечения доступности для общественности и научного сообщества результатов исследований, а также необходимость внедрения в область доклинических и клинических исследований лекарственных средств концепции «встроенного качества», широко применяющейся при производстве лекарственных препаратов