Pugsley Michael K
Pharmacology, Forest Research Institute, Harborview Financial Center, Jersey City, NJ 07311, USA.
Proc West Pharmacol Soc. 2004;47:18-22.
Safety Pharmacology is an integrated discipline that has evolved from the distinct fields of pharmacology, physiology and toxicology. Studies conducted under the guidance of 'Safety Pharmacology' are used to further the discovery, but more importantly, characterize the development of 'safe' biologically active new chemical entities (NCE). Safety Pharmacology studies identify, monitor and characterize potentially undesirable pharmacodynamic activities in non- or pre-clinical studies. This cursory review will highlight the history of Safety Pharmacology and overview the general recommendations of testing strategies used for preclinical core battery studies that are required according to the ICH regulatory S7A and S7B guidelines.
安全药理学是一门从药理学、生理学和毒理学等不同领域发展而来的综合学科。在“安全药理学”指导下开展的研究用于推动新化学实体(NCE)的发现,但更重要的是,对“安全”生物活性新化学实体的研发进行特性描述。安全药理学研究在非临床或临床前研究中识别、监测并描述潜在的不良药效学活性。本简要综述将重点介绍安全药理学的历史,并概述根据国际人用药品注册技术协调会(ICH)监管S7A和S7B指南进行临床前核心组合研究所需的测试策略的一般建议。