Information and Methodological Center for Expertise, Stocktaking and Analysis of Circulation of Medical Products, Roszdravnadzor, Slavyanskay sq., 4-1, 109074, Moscow, Russia; N.N.Semenov Federal Research Center for Chemical Physics, Russian Academy of Sciences, Kosygin 4, 119991, Moscow, Russia.
Information and Methodological Center for Expertise, Stocktaking and Analysis of Circulation of Medical Products, Roszdravnadzor, Slavyanskay sq., 4-1, 109074, Moscow, Russia.
Talanta. 2019 Dec 1;205:120150. doi: 10.1016/j.talanta.2019.120150. Epub 2019 Jul 18.
A detailed step-by-step procedure for revealing counterfeit and substandard tablets is presented. Non-invasive NIR measurements are used for data collection. The entire complex multi-layer object as the "packaging -coating-core" system requires special treatment at all stages of model development and validation. The influence of each layer is studied. A procedure that covers data collection, construction of the model, as well as special internal and external validation is advocated here. A special set of objects called 'nearest of kin' (NoK) collection, which consists of generic medications nearest to the target objects, assists in reliable assessment of the model specificity. The whole procedure summarizes the results obtained for over a thousand different dosage forms of tablets. Two real-world examples of genuine and counterfeit medicines are considered. The first example presents uncoated tablets with high concentration of active ingredient and fairly simple set excipients. Its NoK collection consists of six different manufacturers. The second example presents coated tablets with low concentration of active ingredient and rather complex set of excipients. Its NoK collection is presented by seven different manufacturers.
呈现了一种揭示假药和劣药的详细步骤程序。采用非侵入式近红外（NIR）测量进行数据采集。整个复杂的多层对象作为“包装-涂层-核心”系统，在模型开发和验证的所有阶段都需要特殊处理。研究了每个层的影响。这里提倡涵盖数据收集、模型构建以及特殊内部和外部验证的程序。一组特殊的对象称为“近亲”（NoK）集合，由最接近目标对象的通用药物组成，有助于可靠评估模型的特异性。整个程序总结了一千多种不同剂型片剂的结果。考虑了两个真实世界的正品和假药的例子。第一个例子是高浓度活性成分和相当简单的辅料的未包衣片剂。它的 NoK 集合由六个不同的制造商组成。第二个例子是低浓度活性成分和复杂辅料的包衣片剂。它的 NoK 集合由七个不同的制造商组成。
