吴桂芝adr基本概念wgz617.pptxVIP

药品不良反应Adverse (Drug) Reaction, ADR指合格药品在正常用法用量下出现的与用药目的无关的或意外的有害反应。 A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological functions. ——WHO Technical Report No. 498 (1972)药品不良反应Adverse (Drug) Reaction, ADRexcludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors副作用 (Side Effect)是指药品按正常用法用量使用时所出现的与药品的药理学活性相关，但与用药目的无关的作用。Any unintended effect of a pharmaceutical product occurring at normal dosage which is related to the pha