Safety pharmacology in 2010 and beyond: Survey of significant events of the past 10 years and a roadmap to the immediate-, intermediate- and long-term future in recognition of the tenth anniversary of the Safety Pharmacology Society

被引:8
作者
Bass, Alan S. [1 ]
Vargas, Hugo M. [2 ]
Valentin, Jean-Pierre [3 ]
Kinter, Lewis B. [4 ]
Hammond, Tim [3 ]
Wallis, Rob [7 ]
Siegl, Peter K. S. [5 ]
Yamamoto, Keiji [6 ]
机构
[1] Merck Res Labs, Discovery & Preclin Sci, Global Discovery Sci Support, Boston, MA 02115 USA
[2] Amgen Inc, Toxicol Sci, Safety & Exploratory Pharmacol, Thousand Oaks, CA 91362 USA
[3] Safety Assessment UK, Macclesfield SK10 4TG, Cheshire, England
[4] AstraZeneca, Global Safety Assessment, Wilmington, DE USA
[5] Siegl Pharma Consulting LLC, Blue Bell, PA 19422 USA
[6] Takeda Pharmaceut Co Ltd, Drug Safety Res Labs, Kanagawa 2518555, Japan
[7] Drug Safety Res & Dev, Groton, CT 06340 USA
关键词
Safety Pharmacology; Safety Pharmacology Society; ICH S7A & S7B; Cardiovascular; Respiratory; Central Nervous System; QT INTERVAL PROLONGATION; NONCLINICAL REPOLARIZATION ASSAYS; PREDICTIVE-VALUE; DRUG DISCOVERY; PHARMACEUTICAL-INDUSTRY; SEIZURE LIABILITY; VALIDATION; ZEBRAFISH; PRODACT; ELECTROPHYSIOLOGY;
D O I
10.1016/j.vascn.2011.05.006
中图分类号
R9 [药学];
学科分类号
100702 [药剂学];
摘要
In recognition of the tenth anniversary of the Safety Pharmacology Society (SPS), this review summarizes the significant events of the past 10 years 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. (C) 2011 Elsevier Inc. All rights reserved.
引用
收藏
页码:7 / 15
页数:9
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