安全药理学:作为一门学科实现了四分之一个世纪的里程碑

IF 1.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY
Michael K. Pugsley , Brett R. Winters , Stephen D. Tichenor , Simon Authier , Yevgeniya E. Koshman , Krystle G. Correll , Michael J. Curtis
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引用次数: 0

摘要

这篇社论是《药理学和毒理学方法杂志》(JPTM)关于这些方法在安全药理学(SP)中的应用的年度主题问题的序言。突出显示的内容来自于在美国加利福尼亚州圣地亚哥举行的2024年安全药理学学会(SPS)会议。会议展示了122张海报,其中许多被复制为JPTM上发表的摘要。这些手稿主要反映了核心电池安全性评估和数据分析方法的更新,包括SP内的新研究领域。几项调查的结果,包括SPS的最新薪酬调查,ACT、SPS和STP关于神经毒性的当前行业实践,以及EFPIA、JPMA和PhRMA关于需要重新审视ICH S7A安全性和二级药理学指南的结果,提供了及时的更新。其他手稿包括使用MEA阵列的钠通道阻断体外评估方法,以及使用不同测试程序比较阳性对照药物对hERG通道电流的体外影响。体内心血管手稿包括手术遥测植入方法的概述,自动血液采样方法在SP研究中的应用,常见QTc数据收集方法的性能特征评估,以及用于SP研究的临床使用的可穿戴ECG设备的评估。本文还概述了呼吸性SP的影响,并对在重复给药的非啮齿动物毒理学研究中获取CV数据的方法学方法进行了全面的回顾和比较。连续21年的SP方法主题议题,体现了方法评价的重要性以及SP对方法评价过程的贡献。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety Pharmacology: Achieving a quarter century milestone as a scientific discipline
This editorial prefaces the annual themed issue on those methods with application to safety pharmacology (SP) in the Journal of Pharmacological and Toxicological Methods (JPTM). Highlighted content is derived from the 2024 Safety Pharmacology Society (SPS) meeting held in San Diego, CA, USA. The meeting showcased 122 posters, many of which are reproduced as abstracts published in JPTM. The manuscripts predominantly reflect updates to core battery safety evaluation and data analysis methods and include areas of novel investigation within SP. The results from several surveys including an updated salary survey by the SPS, current industry practices on neurotoxicity by the ACT, SPS and STP and results on the need to revisit the ICH S7A guidance on safety and secondary pharmacology by EFPIA, JPMA, and PhRMA provide timely updates. Other manuscripts include in vitro assessment methods for sodium channel block using MEA arrays, and a comparison of the in vitro effects of positive control drugs on the hERG channel current using different testing procedures. In vivo cardiovascular manuscripts include an overview of surgical telemetry implantation methods, utility of automated blood sampling methods in SP studies, evaluation of the performance characteristics for common QTc data collection methods, and an evaluation of a clinically used wearable ECG device for use in SP studies. There is also an overview of the impact of respiratory SP and a comprehensive review and comparison of current practices regarding methodological approaches used to acquire CV data in repeat-dose non-rodent toxicology studies. The 21 years of consecutive themed issues on SP methods attends to the importance of methods evaluation and the contribution of SP to the process of methods evaluation.
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来源期刊
Journal of pharmacological and toxicological methods
Journal of pharmacological and toxicological methods PHARMACOLOGY & PHARMACY-TOXICOLOGY
CiteScore
3.60
自引率
10.50%
发文量
56
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.
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