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这次会议于1989年9月在渥太华举行,由加拿大国家卫生部主办。会议认为,药物安全性应当受到全社会的高度重视;药物安全性不仅包括药物毒副作用,还应包括药物滥用。专家们指出,即使一个安全药物,滥用也可能出现危险,例如哌醋甲酯和镇痛新的复方,已在有些国家成了海洛因的代用品;药物安全性研究应包括从药品设汁到售后监督的各个阶段,会上报告的内容有:1.药物开发 (1)安全性设计;(2)药品开发中安全性因素。2.毒理学评价 (1)体外模型;(2)动物模型;(3)药品滥用倾向的估计;(4)生物技术制品的安全性评价。3.治疗学范畴 (1)胎儿和儿童安全问题;(2)
The meeting was held in Ottawa in September 1989 and hosted by the Canadian Ministry of Health. The meeting held that drug safety should be highly regarded by society as a whole. Drug safety should include not only drug side effects but also substance abuse. Experts point out that even a safe drug can be at risk of abuse, such as methylphenidate and a new analgesic compound that has become a substitute for heroin in some countries; and drug safety studies should cover everything from drug design to after-sales The various stages of supervision, the report at the meeting are: 1. Drug development (1) safety design; (2) drug development safety factors. 2. TOXICOLOGICAL EVALUATION (1) in vitro models; (2) animal models; (3) estimation of drug abuse tendencies; and (4) safety evaluation of biotechnological products. 3. Therapeutic Areas (1) Fetal and Child Safety Issues; (2)