Репозиторий Университета

© 2019 Elsevier B.V. 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.

© 2019 Journal of Advanced Pharmaceutical Technology  &  Research Published by Wolters Kluwer - Medknow. Species, known as mixture herbal products, are compositions of several types of crushed, sometimes whole, medicinal plant materials with additives; they are a widely used dosage form in the Russian Federation. A large range of species are produced at the pharmaceutical companies. In pharmacopoeial analysis, the most popular and widely used method for the determination of flavonoids, suitable for the standardization of species, is the method of differential spectrophotometry, based on the complexation of flavonoids with aluminum chloride. In accordance with modern requirements for the drugs production, the validation of analytical methods is a prerequisite for the creation of pharmacopoeial monographs projects regulating the quality of pharmaceutical substances of plant origin. Therefore, it is necessary to validate analytical methods for their intended use in evaluating the drug quality. This article discusses/presents the main stages of development and validation (by parameters: accuracy, precision, specificity, linearity) of the methodology for determining total flavonoid content using original species 'Fitourol' as a model.

© 2018, Springer Science+Business Media, LLC, part of Springer Nature. Results from experiments conducted for the parameter Residual Organic Solvents during the course of developing a draft regulation for the drug substance of the innovative pharmacological agent thrombaptanib are reported. The structure of the compound is given. Its pharmacological action is described. A list of potential residual organic solvents was compiled by analyzing the synthetic scheme and manufacturing technology. A separate part of the work describes in detail a developed GC-MS procedure for determining residual organic solvents. Validation results of the procedure for Specificity, Linearity, Accuracy, Precision, and Reproducibility are presented. The validation protocol for the procedure at the time of the studies followed domestic guides for validation that were written based on existing international documents because there was no existing GPM for validation in the current edition of the SP RF. A test sample of thrombaptanib was analyzed using the developed procedure for Residual Organic Solvents. The developed procedure was included in the Residual Organic Solvents section of the draft regulation.

© 2018, Springer Science+Business Media, LLC, part of Springer Nature. Validation results for a spectrophotometric quantitative determination method for ormustine in a lyophilized dosage form are presented. The method is shown to be suitable for quantitative determination of ormustine with respect to parameters such as specificity, linearity, accuracy, repeatability, and intermediate precision.

© 2018 Ima-Press Publishing House. All Rights Reserved. Objective: to develop a Russian version of the modified Rankin Scale (mRS) and to assess its psychometric properties. Patients and methods: The investigation involved 50 patients (25 women, 25 men) over 18 years of age (mean age, 56 years) with an acute cerebrovascular accident diagnosis. During the validation procedure, the authors carried out the linguocultural ratification of mRS, prepared its Russian-language version, and then assessed its psychometric properties (reliability, sensitivity, validity). Results and discussion: Translation and linguistic adaptation of mRS was successfully completed. The results obtained in assessing the psychometric properties of the developed Russian version of the scale reflect its high reliability and the valid and reliable indicators of its sensitivity. A statistical study of constructive and content validity also determined the high significance of differences. Conclusion: The investigation has resulted in the official Russian version of mRS, which is recommended for use by neurologists and rehabilitation specialists in both daily clinical practice and in clinical trials.

© ABV-Press Publishing House. All rights reserved. Background. Objectivization of the characteristics of neuropathic pain is an important component of differential diagnosis in various diseases. Scales and questionnaires are topical diagnostic tools for assessing subjective symptoms for patients and health professionals. Objective to development and validation of the Russian version of the the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS). Materials and methods. The study included two stages: linguocultural ratification and assessment of the psychometric properties of the developed Russian version. Results. The study showed a high level of reliability, validity and sensitivity of the developed Russian-language version of the scale. Conclusion. By the results of the study, the official validated Russian-language version of the scale is presented and recommended for use in work with Russian-speaking patients.

© 2018 ABV-Press Publishing House. All rights reserved. International scales and questionnaires have become widespread in Russian neurology. Validation is a procedure of top priority necessary before applying this kind of diagnostic instrument in Russian-speaking population. In this article, validation of the Boston Carpal Tunnel Questionnaire (BCTQ) intended for patients with this disease is described. Use of validated Russian version would allow to objectively evaluate severity of clinical manifestations of carpal tunnel syndrome and follow patient dynamics. We present the official BCTQ version recommended for use in Russia, as well as data that showed high sensitivity and reliability of this instrument for clinical evaluation of carpal tunnel syndrome.