Bass Alan S, Vargas Hugo M, Valentin Jean-Pierre, Kinter Lewis B, Hammond Tim, Wallis Rob, Siegl Peter K S, Yamamoto Keiji
Global Discovery Sciences Support, Discovery & Preclinical Sciences, Merck Research Laboratories, 33 Avenue Louis Pasteur, MS: BMB 6-101, Boston, MA 02115, USA.
J Pharmacol Toxicol Methods. 2011 Jul-Aug;64(1):7-15. doi: 10.1016/j.vascn.2011.05.006. Epub 2011 Jun 12.
In recognition of the tenth anniversary of the Safety Pharmacology Society (SPS), this review summarizes the significant events of the past 10years that have led to the birth, growth and evolution the SPS and presents a roadmap to the immediate-, intermediate- and long-term future of the SPS. The review discusses (i) the rationale for an optimal non-clinical Safety Pharmacology testing, (ii) the evolution of Safety Pharmacology over the last decade, (iii) its impact on drug discovery and development, (iv) the merits of adopting an integrated risk assessment approach, (v) the translation of non-clinical findings to humans and finally (vi) the future challenges and opportunities facing this discipline. Such challenges include the emergence of new molecular targets and new approaches to treat diseases, the rapid development of science and technologies, the growing regulatory concerns and associated number of guidance documents, and the need to train and educate the next generation of safety pharmacologist.
为纪念安全药理学协会(SPS)成立十周年,本综述总结了过去十年中导致SPS诞生、发展和演变的重大事件,并为SPS的近期、中期和长期未来提供了路线图。该综述讨论了:(i)进行最佳非临床安全药理学测试的基本原理;(ii)过去十年安全药理学的发展;(iii)其对药物发现和开发的影响;(iv)采用综合风险评估方法的优点;(v)非临床研究结果向人体的转化;最后(vi)该学科面临的未来挑战和机遇。这些挑战包括新分子靶点和疾病治疗新方法的出现、科学技术的快速发展、监管关注度的不断提高以及相关指导文件数量的增加,以及培养下一代安全药理学家的需求。