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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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主要な著者: 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
フォーマット: Artigo
言語:Russo
出版事項: 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
シリーズ:Регуляторные исследования и экспертиза лекарственных средств
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オンライン・アクセス:https://www.vedomostincesmp.ru/jour/article/view/732
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