safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/2312-7821-2025-535safetyrisk-535Research ArticleГЛАВНАЯ ТЕМА: ЭВОЛЮЦИЯ ФАРМАКОНАДЗОРА: ИНТЕГРАЦИЯ НОВЫХ ИСТОЧНИКОВ ДАННЫХ, ПОПУЛЯЦИОННЫХ ИCСЛЕДОВАНИЙ И ПРЕДИКТИВНЫХ ТЕХНОЛОГИЙMAIN TOPIC: EVOLUTION OF PHARMACOVIGILANCE: INTEGRATING NEW DATA SOURCES, POPULATION STUDIES AND PREDICTIVE TECHNOLOGIESОткрытые базы данных нежелательных реакций: применение для оценки безопасности разрабатываемых лекарственных средств (обзор)Open-Access Adverse Drug Reaction Databases: Applicability for Safety Assessment of the Developed Drugs (Review)https://orcid.org/0000-0001-7066-7925СавосинаП. И.SavosinaP. I.

Савосина Полина Игоревна

Погодинская ул., д. 10, стр. 8, Москва, 119121

Polina I. Savosina

10/8, Pogodinskaya St., Moscow 119121

polina.savosina@ibmc.msk.ruhttps://orcid.org/0000-0001-7937-2621ПоройковВ. В.PoroikovV. V.

Поройков Владимир Васильевич, академик РАН, профессор, д-р биол. наук, канд. физ.-мат. наук

Погодинская ул., д. 10, стр. 8, Москва, 119121

Vladimir V. Poroikov, Academician of the Russian Academy of Sciences, Professor, Dr. Sci. (Biol.), Cand. Sci. (Phys.-Math.)

10/8, Pogodinskaya St., Moscow 119121

vladimir.poroikov@ibmc.msk.ruhttps://orcid.org/0000-0001-9024-1331ДружиловскийД. С.DruzhilovskiyD. S.

Дружиловский Дмитрий Сергеевич, канд. биол. наук

Погодинская ул., д. 10, стр. 8, Москва, 119121

Dmitry S. Druzhilovskiy, Cand. Sci. (Biol.)

10/8, Pogodinskaya St., Moscow 119121

dmitry.druzhilovsky@ibmc.msk.ruФедеральное государственное бюджетное научное учреждение «Научно-исследовательский институт биомедицинской химии имени В.Н. Ореховича»РоссияInstitute of Biomedical ChemistryRussian Federation202631032026141619Copyright © Савосина П.И., Поройков В.В., Дружиловский Д.С., 20262026Савосина П.И., Поройков В.В., Дружиловский Д.С.Savosina P.I., Poroikov V.V., Druzhilovskiy D.S.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/535ВВЕДЕНИЕ

ВВЕДЕНИЕ. Важным этапом разработки лекарственных средств является оценка информации о безопасности уже зарегистрированных лекарственных препаратов (ЛП). Регуляторными органами и отдельными исследовательскими группами созданы и поддерживаются базы данных (БД) нежелательных реакций (НР) при применении ЛП. Сведения, агрегированные в таких БД, могут использоваться для создания справочных и обучающих наборов данных для экспериментальных и in silico исследований. Упростить выбор БД, релевантных для целей конкретного исследования, позволит предварительная оценка и систематизация представленной в них информации.

ЦЕЛЬ

ЦЕЛЬ. Оценка возможности применения открытых баз данных для исследования безопасности лекарственных средств.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Изучены 11 БД с открытым доступом, содержащих сведения о НР ЛП: FAERS, DAEN, MedEffect Canada, EudraVigilance, VigiBase, SIDER, MetaADEDB, ADReCS-Target, T-ARDIS, OnSIDES, WWAD. Различия БД обусловлены прежде всего используемыми источниками информации: спонтанные сообщения (FAERS, DAEN, MedEffect Canada, EudraVigilance, VigiBase), инструкции по медицинскому применению ЛП и официальные документы (SIDER, OnSIDES, WWAD), научные публикации (ADReCS-Target) и другие открытые веб-ресурсы (MetaADEDB, T-ARDIS). Все рассмотренные БД могут быть использованы для информационной поддержки и анализа профиля безопасности ЛП. При проведении доклинических исследований, в частности для создания используемых в in silico методах обучающих выборок, полезны SIDER, MetaADEDB, ADReCS-Target, OnSIDES и WWAD. Генерация гипотез о возможных механизмах возникновения НР, поиск новых направлений репозиционирования ЛП могут быть осуществлены с помощью ADReCS-Target, WWAD и T-ARDIS благодаря представленной в них дополнительной информации о фармацевтических субстанциях и молекулярных мишенях. Использование методов автоматизированного анализа текстов без тщательной последующей ручной проверки при построении БД, таких как ADReCS-Target, T-ARDIS, OnSIDES и MetaADEDB, ограничивает их применение для задач, требующих высокой степени достоверности анализируемой информации.

ВЫВОДЫ

ВЫВОДЫ. Рассмотренные БД НР могут служить ценным инструментом для решения широкого круга медико-биологических задач. При выборе БД, релевантной для конкретного исследования, необходимо учитывать принципы, лежащие в основе ее создания, поскольку различия в источниках и методах аннотирования могут влиять на достоверность результатов.

INTRODUCTION

INTRODUCTION. Evaluating safety data on already registered drugs is an important stage in medicine development. Databases (DBs) of adverse drug reactions (ADRs) have been created and maintained by regulatory authorities and individual research groups. The data aggregated in such DBs can help create reference and training datasets for experimental and in silico studies. A preliminary assessment and systematisation of information from these databases can facilitate the selection of DBs relevant to a specific study.

AIM

AIM. This study aimed to assess applicability of public ADR databases for safety studies of medicinal products.

DISCUSSION

DISCUSSION. Eleven public DBs that provide information on ADRs of approved drugs were studied: FAERS, DAEN, MedEffect Canada, EudraVigilance, VigiBase, SIDER, MetaADEDB, ADReCS-Target, T-ARDIS, OnSIDES, and WWAD. The differences between these databases are primarily due to the variety of sources they use: spontaneous reports (FAERS, DAEN, MEDEFFECT, EudraVigilance, VigiBase), patient information leaflets and other official documents (SIDER, OnSIDES, WWAD), scientific publications (ADReCS-Target), and other open-access web resources (MetaADEDB, T-ARDIS). All the reviewed databases can be used for informational support and analysis of drug safety profiles. SIDER, MetaADEDB, ADReCS-Target, OnSIDES, and WWAD are useful in preclinical studies, particularly while developing training sets for in silico methods. Hypotheses for possible ADR mechanisms and search for new drug repurposing vectors can be arranged using ADReCS-Target, WWAD, and T-ARDIS, since these DBs provide additional data on active pharmaceutical substances or target molecules. Using computer-aided methods without thorough hands-on search in the DBs such as ADReCS-Target, T-ARDIS, OnSIDES, and MetaADEDB, limits their applicability in tasks requiring accurately analysed information.

CONCLUSIONS

CONCLUSIONS. The DBs reviewed can serve as a valuable tool for addressing a wide range of biomedical issues. To select a DB relevant for a specific study, it is important to consider the underlying principles, since varying sources and annotation methods can affect the reliability of results.

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