Preclinical safety studies of medicines in the Eurasian economic union

Preclinical safety studies of medicines in the Eurasian economic union

This article analyzes the regulatory, scientific, and methodological documents of the Eurasian Economic Union (EAEU) and the Russian Federation devoted to conducting preclinical studies on the safety of medicines. Areas for which it is advisable to develop special EAEU guidelines for conducting prec...

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Bibliographic Details
Main Authors: G. N. Engalycheva, R. D. Syubaev, A. D. Durnev
Format: Article
Language:Russian
Published: LLC “Publisher OKI” 2025-05-01
Series:Фармакокинетика и Фармакодинамика
Subjects:
medicines
preclinical studies
acute toxicity
repeated administration toxicity
pharmacological safety
toxicokinetic studies
genotoxicity
local tolerability
carcinogenicity
reproductive and ontogenetic toxicity
immunotoxicity
phototoxicity
drug dependence
safety assessment
Online Access:https://www.pharmacokinetica.ru/jour/article/view/445
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Summary:This article analyzes the regulatory, scientific, and methodological documents of the Eurasian Economic Union (EAEU) and the Russian Federation devoted to conducting preclinical studies on the safety of medicines. Areas for which it is advisable to develop special EAEU guidelines for conducting preclinical safety studies have been identified. Based on an analysis of the international regulatory and methodological framework, elements of foreign experience in preclinical assessment of the safety of medicines for transfer to the practice of the Union are proposed.
ISSN:2587-7836
2686-8830

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