Safety pharmacology 2023 and implementation of the ICH E14/S7B Q&A guidance document

IF 1.3 4区 医学 Q4 PHARMACOLOGY & PHARMACY Journal of pharmacological and toxicological methods Pub Date : 2023-09-01 DOI:10.1016/j.vascn.2023.107300
Michael K. Pugsley , Yevgeniya E. Koshman , C. Michael Foley , Brett R. Winters , Simon Authier , Michael J. Curtis
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Abstract

This editorial prefaces the annual themed issue on safety pharmacology (SP) methods published since 2004 in the Journal of Pharmacological and Toxicological Methods (JPTM). We highlight here the content derived from the recent 2022 Safety Pharmacology Society (SPS) and Canadian Society of Pharmacology and Therapeutics (CSPT) joint meeting held in Montreal, Quebec, Canada. The meeting also generated 179 abstracts (reproduced in the current volume of JPTM). As in previous years the manuscripts reflect various areas of innovation in SP including a comparison of the sensitivity of cross-over and parallel study designs for QTc assessment, use of human-induced pluripotent stem cell (hi-PSC) neuronal cell preparations for use in neuropharmacological safety screening, and hiPSC derived cardiac myocytes in assessing inotropic adversity. With respect to the latter, we anticipate the emergence of a large data set of positive and negative controls that will test whether the imperative to miniaturize, humanize and create a high throughput process is offset by any loss of precision and accuracy.

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安全药理学2023和ICH E14/S7B问答指导文件的实施。
这篇社论是自2004年以来在药理学和毒理学方法杂志(JPTM)上发表的关于安全药理学(SP)方法的年度主题问题的序言。我们在这里强调的内容来源于最近在加拿大魁北克省蒙特利尔举行的2022年安全药理学学会(SPS)和加拿大药理学和治疗学学会(CSPT)联合会议。会议还产生了179个摘要(转载于JPTM的当前卷)。与前几年一样,手稿反映了SP的各个创新领域,包括QTc评估的交叉和平行研究设计的敏感性比较,用于神经药理学安全性筛选的人类诱导多能干细胞(hi-PSC)神经细胞制剂的使用,以及用于评估肌力逆境的hiPSC衍生心肌细胞。对于后者,我们预计将出现大量的积极和消极控制数据集,这些数据集将测试小型化、人性化和创建高吞吐量流程的必要性是否会被精度和准确性的任何损失所抵消。
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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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