vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2022-12-2-205-213vedomostiregmed-430Research ArticleКЛИНИЧЕСКАЯ ФАРМАКОЛОГИЯCLINICAL PHARMACOLOGYКоличественная клиническая фармакология и пациент-ориентированные технологии здравоохранения: перспективы 2030Quantitative clinical pharmacology and patient-centered healthcare technologies: perspectives 2030https://orcid.org/0000-0002-0258-4092ПетровВ. И.PetrovV. I.

Петров Владимир Иванович, академик РАН, д-р мед. наук, профессор

пл. Павших Борцов, д. 1, Волгоград, 400131

Vladimir I. Petrov, Academician of RAS, Dr. Sci. (Med.), Professor

1, Pavshikh Bortsov Sq., Volgograd 400131

vipetrov@volgmed.ruhttps://orcid.org/0000-0002-7934-6586ТолкачевБ. Е.TolkachevB. E.

Толкачев Борис Евгеньевич, канд. мед. наук

пл. Павших Борцов, д. 1, Волгоград, 400131

Boris E. Tolkachev, Cand. Sci. (Med.)

1, Pavshikh Bortsov Sq., Volgograd 400131

boris.volgmed@mail.ruФедеральное государственное бюджетное учреждение «Волгоградский государственный медицинский университет» Министерства здравоохранения Российской Федерации; Государственное бюджетное учреждение «Волгоградский медицинский научный центр»РоссияVolgograd State Medical University; Volgograd Medical Scientific CentreRussian Federation202217052022122205213Copyright © Петров В.И., Толкачев Б.Е., 20222022Петров В.И., Толкачев Б.Е.Petrov V.I., Tolkachev B.E.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/430

Использование количественных (фармакостатистических) подходов при изучении зависимости между дозой лекарственного средства и фармакологическим ответом, а также для прогнозирования вариабельности параметров этой зависимости с учетом пациент-специфических характеристик (ковариат) является одним из наиболее перспективных направлений развития классической клинической фармакологии, называемом фармакометрика. Цель работы  — оценить значимость и перспективы развития количественной клинической фармакологии в условиях перехода системы здравоохранения на ценностно-обоснованную модель. Показано, что ключевыми предпосылками для развития фармакометрики явились разработка методологической математико-статистической базы, основанной на построении нелинейных смешанных регрессионных моделей, и становление парадигмы персонализированной медицины, нацеленной на разработку стратегий индивидуализированного назначения лекарственных препаратов. Обоснована необходимость использования сведений о зависимости «доза–эффект», полученных в результате надлежащим образом документированного поискового анализа информации, находящейся в существующих или вновь создаваемых базах данных. Дальнейшая интеграция фармакостатистического моделирования и технологий обработки данных реальной клинической практики, а также их включение в оценку клинико-экономической эффективности медицинских технологий позволят сократить время для принятия наиболее рациональных решений, способствуя тем самым переходу системы здравоохранения на ценностно-обоснованную модель.

One of the most promising trends in clinical pharmacology is pharmacometrics, a combination of pharmacology and statistics that implements quantitative approaches for characterising dose–response relationships and predicting the variability of these relationships attributable to patient-specific characteristics (covariates). The aim of the study was to evaluate the significance of quantitative clinical pharmacology and discuss opportunities for its development in the context of health systems moving towards the value-based care model. The study showed that two key prerequisites for pharmacometrics development were the advancements in mathematical and statistical methodology based upon non-linear mixed effects regression modelling and the emergence of a personalised medicine paradigm aimed at creation of strategies for individualised prescribing of medicinal products. The study demonstrated the necessity for using the dose–response relationship information obtained by exploratory analysis of data stored in existing and newly created bases. Further integration of pharmacostatistical modelling and real-world data processing technologies, as well as their incorporation into clinical and economic evaluation of health technologies, will streamline decision making and, thus, facilitate the transition of health systems to the value-based model.

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