Quigley M A, White K L, McGraw B F
Acta Pharmacol Toxicol (Copenh). 1985;57 Suppl 2:61-73. doi: 10.1111/j.1600-0773.1985.tb03576.x.
The safety of medicinal agents being introduced into the marketplace is of growing concern to consumers, health care providers, and regulatory agencies. Although there are ever increasing efforts to improve techniques for testing drugs, and for anticipating and confirming possible adverse effects, arrangements for monitoring and detecting adverse drug reactions are far from satisfactory. Some factors which need to be understood in order to appropriately interpret data include: maturation processes; pretesting affects, measuring instruments affects; selection bias; and the affects of differential experimental mortality. A safety profile has been presented for the calcium entry blocker diltiazem hydrochloride. Efforts were made to focus attention upon the source of safety information as it relates to the quality of the report. The data presented suggests that diltiazem hydrochloride has a low incidence of adverse experiences.
进入市场的药物安全性越来越受到消费者、医疗保健提供者和监管机构的关注。尽管人们不断努力改进药物测试技术以及预测和确认可能的不良反应，但监测和检测药物不良反应的安排仍远不能令人满意。为了正确解释数据，需要了解一些因素，包括：成熟过程；预测试影响、测量仪器影响；选择偏倚；以及不同实验死亡率的影响。已给出了钙通道阻滞剂盐酸地尔硫䓬的安全性概况。已努力将注意力集中在与报告质量相关的安全信息来源上。所呈现的数据表明盐酸地尔硫䓬不良反应的发生率较低。
