Copyright: © 2026 by the authors. Licensee: Pirogov University.
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (CC BY).

OPINION

Legal, clinical, and ethical issues in bioequivalence research

About authors

Yaroslavl State Medical University, Yaroslavl, Russia

Correspondence should be addressed: Elena G. Lileeva
Revolutsionnaya St., 5, Yaroslavl, 150000, Russia; ur.xednay@6002aveelile

About paper

Author contribution: Speshilova SA — selection and analysis of literature, writing the text; Lileeva EG — scientific guidance, methodological support, final editing and approval of the text; Sinitsina OA — selection and analysis of literature, text editing.

Received: 2025-12-11 Accepted: 2026-02-14 Published online: 2026-02-26
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Table. Comparison of BE studies by year (according to the data of the Ministry of Health of Russia and Association of Clinical Research Organizations, 2021–2024) [4]