术语学习：安全性
Safety
无限火力盖伦构建和谐社区安全性
英英解释：Practical certainty that adver effects will not result from exposure to an agent under defined circumstances. (Ref. 2)
中文解释：特定环境下，接触物质不会发生不良反应的实际确定性。
原始出处：ICH Q3D
Safety & Tolerability
安全性和耐受性
英英解释：The safety of a medical product concerns the medical risk to the subject, usually assd in a clinical trial by laboratory tests (including clinical chemistry and haematology),
vital signs,clinical adver events (dias, signs and symptoms), and other special safety tests (e.g. ECGs, ophthalmology). The tolerability of the medical product reprents the degree to which overt adver effects can be tolerated by the subject.
中文解释：医药产品对医疗对象产生的医疗风险。通常通过实验室临床试验（包括临床化学和血液病学），生命体征，临床不良事件（疾病，体征和症状）和其他特定的安全试验（如心电图，眼科学）进行评估。医疗产品的耐受性表示医疗对象对明显不良反应的耐受程度。
原始出处：ICH E9
Safety Asssment
粘豆包的做法安全性评估
英英解释：An approach that focus on the scientific understanding and measurement of chemical hazards as well as chemical exposures, and ultimately the risks associated with them. This term is often (and in this guideline) ud synonymously with risk asssment.
(Ref. 2)
中文解释：对化学有害物和化学接触，及相关最终风险的科学认识和评估的方法。这个术语通常用作风险评估的同义词。（Ref.2）
原始出处：ICH Q3D
Safety concern
魔方新手入门安全性
英英解释：An important identified risk, important potential risk, or important missing information.
中文解释：指重大可识别风险，重大潜在风险，或缺失的重要信息
原始出处：ICH Q3D, ICH Q9
Safety Factor
春节是几月几日安全系数
英英解释：A composite (reductive) factor applied by the risk asssment experts to the NOAEL or other reference point,such as the benchmark do or benchmark do lower confidence limit, to derive a reference do that is considered safe or without appreciable risk, such as an acceptable daily intake or tolerable daily intake (the NOAEL or other reference point is divided by the safety factor to calculate the reference do). The value of the safety factor depends on the nature of the toxic effect, the size and type of population to be protected, and the quality of the toxicological information available. See related terms: Asssment factor, Uncertainty factor.(Ref. 2)
中文解释：风险评估专家用于NOAEL 或其他参考点（如基准剂量或基准剂量置信下限）的一个组合（简约）系数，以获得一个被认为安全或无明显风险的参考剂量，如可接受日摄入量或每日耐受摄入量（NOAEL 或其他被安全系数划分以计算参考剂量的参考点）。安全系数数值取决于毒性作用的性质，被保护的人口的规模和类型，及可用的毒理学资料的质量。见相关术语：风险系数，不确定系数。
家长委员会
环保检查原始出处：ICH Q3D
Safety Message
安全性信息
立定三级跳
英英解释：A safety message is an EDI message including the information provided for one/more Individual Ca Safety Reports contained in one safety file exchanged between one nder and one receiver in one message transaction.[EMA]
中文解释：安全性信息是EDI 消息，包括在信息传输中一个发送者和一个接收者之间交换的安全性文件中的一个/多个个例安全性报告中提供的信息个例。[EMA]
原始出处：ICH E2B(R3)
来源：电子版参阅“国际药品注册网—术语学习”
