Detection of counterfeit and substandard tablets using non-invasive NIR and chemometrics - A conceptual framework for a big screening system
Rodionova O. Y., Titova A. V., Baly'klova K. S., Pomerantsev A. L.
Talanta
Vol.205, Num.120150
Опубликовано: 2019
Тип ресурса: Статья
DOI:10.1016/j.talanta.2019.120150
Аннотация:
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
Ключевые слова:
DD-SIMCA; Falsified and substandard medicines; Internal and external validation; NIR based approach; NoK-validation
Crime; Infrared devices; Manufacture; Conceptual frameworks; Counterfeit medicines; DD-SIMCA; Internal and external validation; NIR based approach; NoK-validation; Reliable assessment; Step by step procedure; Data acquisition; bisoprolol; counterfeit drug; furosemide; near infrared spectroscopy; standard; tablet; Bisoprolol; Cheminformatics; Counterfeit Drugs; Furosemide; Reference Standards; Spectroscopy, Near-Infrared; Tablets
Язык текста: Английский
ISSN: 1873-3573
Rodionova O. Y.
Titova A. V.
Baly'klova K. S. Kseniya Sergeevna 1986-
Pomerantsev A. L.
Родионова О. Y.
Титова А. В.
Балыклова К. С. Ксения Сергеевна 1986-
Померанцев А. Л.
Detection of counterfeit and substandard tablets using non-invasive NIR and chemometrics - A conceptual framework for a big screening system
Текст визуальный непосредственный
Talanta
Elsevier Science Publisher B.V.
Vol.205 Num.120150
2019
Статья
DD-SIMCA Falsified and substandard medicines Internal and external validation NIR based approach NoK-validation
Crime Infrared devices Manufacture Conceptual frameworks Counterfeit medicines DD-SIMCA Internal and external validation NIR based approach NoK-validation Reliable assessment Step by step procedure Data acquisition bisoprolol counterfeit drug furosemide near infrared spectroscopy standard tablet Bisoprolol Cheminformatics Counterfeit Drugs Furosemide Reference Standards Spectroscopy, Near-Infrared Tablets
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