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.

中文翻译：

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药物标准样品开发的现代方法

本综述介绍了世界各地和俄罗斯标准样品 (SS) 的创建历史，以及基于使用 SS 的国家药品标准化系统 (MP) 的现状研究。药品领域的标准化旨在保证标准化项目的质量，包括产品（原材料、其他材料、现成的 MP 等）、服务和流程。制造技术的不断发展和新型 MP 的发现增加了对标准样品的需求，因为药物质量控制涉及使用复杂、高效、特异性和精确的物理化学和生物分析方法。