The integrated model of quality management system of laboratory studies of medicines (Review)

Introduction. The publication is devoted to the role of laboratory research in ensuring the quality of domestic medicines and is a review and analysis of regulatory documents and current publications on this topic. Text. A number of different types of laboratories are involved in Drug life cycle and ensuring their effectiveness and safety. Today there are a large number of regulations governing laboratory research. Common to all types of laboratories and regulatory documents is the need to organize an effective quality management system (QMS) for the drug life cycle laboratories. The aim of this review is to analyze approaches to regulating the quality of laboratory research of domestic drugs and to consider the most effective QMS model, which is fundamental for all types of laboratories in the life cycle of drugs. Conclusion. The laboratory research quality system serves as a basic tool for achieving the ultimate goal-the clinical value of drugs and is designed to ensure that risks for patients are minimized. At the same time, each stage of the drug life cycle provides a solution to a specific problem on the way to this goal, which must be taken into account when building a QMS in each type of laboratory. The range of regulatory documents and external assessment systems (accreditation, certification, inspection control, etc.) in the field of domestic laboratory research is quite diverse. In this regard, it is advisable for the laboratory to build a harmonious QMS based on priorities in accordance with the goals and objectives. The most effective method for building such a system is an integrated management system model. © Selezneva A. I., Smirnov V. A., Goryachkin V. V., Chadova N. N., Polyakov S. V., Shestakov V. N., Abramovich R. A., 2021

Modern Approaches to the Development of Standard Samples of Drugs

This review addresses the history of the creation of standard samples (SS) around the world and in Russia, along with studies of the current condition of the state system for standardization of medicinal products (MP) based on the use of SS. Standardization in the area of drugs is directed to guaranteeing the quality of the items standardized, which includes products (raw materials, other materials, ready MP, etc.), services, and processes. The continuing development of manufacturing technologies and the discovery of novel MP increases the need for standard samples, as drug quality control involves the use of complex, highly effective, specific, and precise physicochemical and biological analysis methods. © 2020, Springer Science+Business Media, LLC, part of Springer Nature

Статистический анализ использования антидепрессантов группы СИОЗС флуоксетина и флувоксамина при оказании стационарной помощи больным депрессивными расстройствами

Depression is a state of multifocal etiology, including genetic, biochemical, hormonal, psychological and social components and manifested in the suppression of mental disorders. More than 300 million people from all age groups suffer from it. It was revealed that women are more prone to depression than men. Depression makes a significant “contribution” to the global burden of disease - it is believed that by 2020 it will be the second cause of disability in the world after coronary heart disease.Депрессия - состояние мультифокальной этиологии, включающее генетическое, биохимические, гормональные, психологические и социальные компоненты и проявляющееся в подавлении психических расстройств. От нее страдает более 300 миллионов человек из всех возрастных групп. Выявлено, что женщины в большей мере подвержены депрессии, чем мужчины. Депрессия вносит значительный «вклад» в глобальное бремя болезней - считается, что к 2020 году она станет второй после ишемической болезни сердца причиной инвалидности в мире