clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИ10.37489/2588-0519-2020-1-80-99clinvest-484Research ArticleИССЛЕДОВАНИЯ БИОЭКВИВАЛЕНТНОСТИBIOEQUIVALENCE STUDIESВозможность прогнозирования результатов исследований биоэквивалентности на основе последовательного статистического анализа информативных факторовThe ability to predict the results of bioequivalence studies based on a consistent statistical analysis of informative factorshttps://orcid.org/0000-0002-2980-4518РомодановскийД. П.RomodanovskyDmitry P

к.м.н., главный эксперт управления №1 по эффективности и безопасности лекарственных средств Центра экспертизы и контроля готовых лекарственных средств, ФГБУ «Научный центр экспертизы средств медицинского применения»

CMS, Chief Expert of Division №1 on Medicinal Products’ Efficacy and Safety of Centre For Evaluation and Control of Medicinal Products. Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products»

d.romodanovsky@mail.ruhttps://orcid.org/0000-0002-0032-0341ХохловА. Л.KhokhlovAlexandr L

д.м.н., профессор, член-корр. РАН, зав. кафедрой клинической фармакологии, ФГБОУ ВО «Ярославский государственный медицинский университет»

DM, professor, corresponding member of RAS, Head of Department of Clinical Pharmacology of Federal State Budgetary Educational Institution of Higher Education «Yaroslavl State Medical University»

al460935@yandex.ruФГБУ «Научный центр экспертизы средств медицинского применения», МоскваРоссияFederal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products»Russian FederationФГБОУ ВО «Ярославский государственный медицинский университет», ЯрославльРоссияFederal State Budgetary Educational Institution of Higher Education «Yaroslavl State Medical University»Russian Federation202016052020018099Copyright © Ромодановский Д.П., Хохлов А.Л., 20202020Ромодановский Д.П., Хохлов А.Л.Romodanovsky D.P., Khokhlov A.L.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.clinvest.ru/jour/article/view/484Резюме

Резюме. Прогнозирование результатов исследования биоэквивалентности является актуальной и важной задачей при разработке протоколов клинических исследований биоэквивалентности. Цель работы: разработать алгоритм прогнозирования результатов биоэквивалентности на основе факторов, обладающих достаточной степенью информативности.

Материалы и методы

Материалы и методы: проведен анализ основных факторов, сопряженных с проведением исследований биоэквивалентности, на данных 290 исследований биоэквивалентности; охарактеризована информативность факторов и определены соответствующие балы (прогностические коэффициенты) каждой градации каждого фактора; разработана прогностическая таблица и алгоритм расчета прогноза; выполнен анализ чувствительности и специфичности разработанного прогностического алгоритма в сравнении с контрольной выборкой (данные 65 исследований биоэквивалентной из открытых источников). Статистическую обработку проводили с помощью программ SSPS Statistics v. 25. и Microsoft Office Excel 2016.

Результаты

Результаты: Описаны результаты выполненных анализов по определению информативных факторов различными методами оценки. Приведены уравнения для выполнения соответствующих расчетов. Показаны ключевые и наиболее информативные признаки, на основании которых создана прогностическая таблица и разработан алгоритм прогноза. Представлены результаты анализа чувствительности и специфичности алгоритма прогнозирования результатов исследований биоэквивалентности.

Заключение

Заключение: разработан алгоритм прогнозирования результатов биоэквивалентности на основе факторов, обладающих достаточной степенью информативности. Алгоритм показал высокие значения чувствительности и специфичности, а также низкий процент ошибок.

Predicting the results of bioequivalence studies is an urgent and important task in developing protocols for clinical studies of bioequivalence. Objective: to develop an algorithm for predicting bioequivalence results based on factors with a sufficient degree of informativeness. Materials and methods: the analysis of the main factors associated with conducting bioequivalence studies on the data of 290 bioequivalence studies; the informativeness of the factors is characterized and the corresponding points (prognostic factors) of each gradation of each factor are determined; a forecast table and forecast calculation algorithm have been developed; The sensitivity and specificity of the developed prognostic algorithm are compared with the control sample (data from 65 bioequivalent studies from open sources). Statistical processing was performed using SSPS Statistics v. 25 and Microsoft Office Excel 2016. Results: The results of the analysis performed to determine the informative factors by various assessment methods are described. Equations are given for performing the corresponding calculations. The key and most informative features are shown, on the basis of which a forecast table is created and a forecast algorithm is developed. The results of the analysis of the sensitivity and specificity of the algorithm for predicting the results of bioequivalence studies are presented. Conclusion: an algorithm and a calculator for predicting the results of bioequivalence based on factors with a sufficient degree of information content have been developed. The algorithm showed high values of sensitivity and specificity, as well as a low percentage of errors.

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The authors declare that there are no conflicts of interest present.