蒲公英双语课堂丨安全性和耐受性

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您可以边看文字和视频，双重记忆保障、学习更牢固。 您也可以放松双眼，让给耳朵享受美妙、纯正的中英文听力。 安全性和耐受性   Safety & Tolerability  [Source 来源: ICH] ICH E9 The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and haematology) , vital signs, clinical adverse events (diseases, signs and symptoms) , and other special safety tests (e.g. ECGs, ophthalmology) . The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject. 医疗产品的安全性是指受试者的医学风险，通常在临床试验中由实验室检查 (包括临床生化和血液学) 、生命体征、临床不良事件 (疾病、体征和症状) ，以及其它特殊的安全性检查 (如心电图、眼科检查) 等来评价。医疗产品的耐受性是指受试者能耐受 ………………………………