新药的安全性评估必须以全面的、完整的副作用资料,特别是所有临床试验数据为基础。安全性的评估是一种间接分析,虽然这种分析没有药物有效性的分析来得明确,但应认识到,安全性评估是一种新观念。我们期望能采用这种方法评估新药,并将研究着重点放在个体临床研究上,特别是对照性 The safety assessment of a new drug must be based on comprehensive and complete data on side effects, in particular on all clinical trial data. An assessment of safety is an indirect analysis. Although this analysis is not clear in the analysis of drug availability, it should be recognized that safety assessment is a new concept. We expect to use this method to evaluate new drugs and focus our research on individual clinical research, especially with regard to control