深呼吸：基于证据的呼吸安全评估方法

IF 1.3 4区医学 Q4 PHARMACOLOGY & PHARMACY

Journal of pharmacological and toxicological methods Pub Date : 2025-05-02 DOI:10.1016/j.vascn.2025.107744

John J. Kremer , Matt Bridgland-Taylor , Matt Clark , Mike G. Rolf , Martin Traebert , Gregory S. Friedrichs

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引用次数: 0

摘要

应进行非临床呼吸检测的必要性和实施的现代化，以增强其对临床结果的转化影响，优化动物和开发成本，并最终加强监管相关性。本文阐述了为什么国际协调会议（ICH） S7A授权的呼吸检测应该更新，为预期风险最小的推定治疗方法提供了一种潜在的简化方法，并建议对呼吸安全危害进行更严格的补充调查。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Taking a deep breath: Evidence-based approaches to respiratory safety assessment

Modernization of the necessity and conduct of nonclinical respiratory assays should be undertaken to enhance their translational impact for clinical outcomes, optimize animal and development costs, and ultimately strengthen regulatory relevance. This manuscript offers a perspective on why the International Conference on Harmonization (ICH) S7A mandated respiratory assay should be updated, offering a potential streamlined approach for putative therapeutics with minimal expected risks, and recommendations on more rigorous, supplemental investigations of respiratory safety hazards.

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来源期刊

Journal of pharmacological and toxicological methods PHARMACOLOGY & PHARMACY-TOXICOLOGY

CiteScore

3.60

自引率

10.50%

发文量

审稿时长

26 days

期刊介绍： Journal of Pharmacological and Toxicological Methods publishes original articles on current methods of investigation used in pharmacology and toxicology. Pharmacology and toxicology are defined in the broadest sense, referring to actions of drugs and chemicals on all living systems. With its international editorial board and noted contributors, Journal of Pharmacological and Toxicological Methods is the leading journal devoted exclusively to experimental procedures used by pharmacologists and toxicologists.