Interpretation of toxicological research data in establishing the no observed adverse effect level (NOAEL) for medicinal products

Interpretation of toxicological research data in establishing the no observed adverse effect level (NOAEL) for medicinal products

INTRODUCTION. Toxicological studies of new pharmaceuticals in laboratory animals represent an obligatory stage in drug risk assessment, designed to identify toxic effects, their potential reversibility, and dependence on dose and/or systemic exposure. The primary quantitative outcome of these studie...

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Main Authors: K. L. Kryshen, Ya. A. Gushchin, N. M. Faustova, S. V. Gushchina, Zh. Yu. Ustenko, A. E. Katelnikova, K. T. Sultanova, A. A. Matichin, V. A. Vavilova, Ya. G. Murazov, M. V. Miroshnikov, M. A. Kovaleva, D. V. Shubin, V. G. Makarov, M. N. Makarova
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2025-07-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
toxicological studies
laboratory animals
biological significance
adverse effects
noael (no observed adverse effect level)
weight-of-evidence principle
preclinical studies
Online Access:https://www.vedomostincesmp.ru/jour/article/view/732
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