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安全药理学协会战略计划概述。

An overview of the safety pharmacology society strategic plan.

作者信息

Pugsley M K, Authier S, Koerner J E, Redfern W S, Markgraf C G, Brabham T, Correll K, Soloviev M V, Botchway A, Engwall M, Traebert M, Valentin J-P, Mow T J, Greiter-Wilke A, Leishman D J, Vargas H M

机构信息

Purdue Pharma L.P., Stamford, CT 06901, USA.

CiToxLAB North America, Laval, QC, Canada.

出版信息

J Pharmacol Toxicol Methods. 2018 Sep-Oct;93:35-45. doi: 10.1016/j.vascn.2018.01.001. Epub 2018 Jan 9.

Abstract

Safety Pharmacology studies are conducted to characterize the confidence by which biologically active new chemical entities (NCE) may be anticipated as safe. Non-clinical safety pharmacology studies aim to detect and characterize potentially undesirable pharmacodynamic activities using an array of in silico, in vitro and in vivo animal models. While a broad spectrum of methodological innovation and advancement of the science occurs within the Safety Pharmacology Society, the society also focuses on partnerships with health authorities and technology providers and facilitates interaction with organizations of common interest such as pharmacology, physiology, neuroscience, cardiology and toxicology. Education remains a primary emphasis for the society through content derived from regional and annual meetings, webinars and publication of its works it seeks to inform the general scientific and regulatory community. In considering the future of safety pharmacology the society has developed a strategy to successfully navigate forward and not be mired in stagnation of the discipline. Strategy can be defined in numerous ways but generally involves establishing and setting goals, determining what actions are needed to achieve those goals, and mobilizing resources within the society to accomplish the actions. The discipline remains in rapid evolution and its coverage is certain to expand to provide better guidance for more systems in the next few years. This overview from the Safety Pharmacology Society will outline the strategic plan from 2016 to 2018 and beyond and provide insight into the future of the discipline which builds upon a previous strategic plan established in 2009.

摘要

进行安全药理学研究是为了确定具有生物活性的新化学实体(NCE)有望安全的可信度。非临床安全药理学研究旨在使用一系列计算机模拟、体外和体内动物模型来检测和表征潜在的不良药效学活性。虽然安全药理学协会内部出现了广泛的方法创新和科学进步,但该协会还注重与卫生当局和技术提供商建立伙伴关系,并促进与药理学、生理学、神经科学、心脏病学和毒理学等共同感兴趣的组织进行互动。通过区域会议、年度会议、网络研讨会以及其作品的出版所产生的内容,教育仍然是该协会的主要重点,它力求为广大科学和监管界提供信息。在考虑安全药理学的未来时,该协会制定了一项战略,以成功向前发展,而不会陷入该学科的停滞状态。战略可以用多种方式来定义,但通常包括设定目标、确定实现这些目标所需的行动,以及调动协会内部的资源来完成这些行动。该学科仍在快速发展,其覆盖范围肯定会在未来几年内扩大,以便为更多系统提供更好的指导。安全药理学协会的这篇综述将概述2016年至2018年及以后的战略计划,并深入探讨该学科的未来,这是在2009年制定的先前战略计划的基础上进行的。

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