药物监视-财团法人医药品查验中心.PDF

梁 2 念 了 索療療切 年來 理(risk management) (risk assessment) (risk communication) 益 (benefit assessment) 3 類 來 益降 來 兩年 理 (Food and Drug Administration) 立 (Office of Drug Safety) 理 了療 3 臨 (highly selected) 數 不(兩) 不良(Important Adverse Drug Reactions) 臨 識 來2 Timothy Brewer MD 例暴露 (drug exposures)更 1 不良2 不良 良 (Good Pharmacovigilance Practices) 4 (Pharmacovigilance) (WHO) 不良 (detection) (assessment) 了 (understanding)(prevention) 不良 流行 Annex 了(pharmacovigilance methods) 來識 (signal detection) (pharmacovigilance methods) :( ) (passive surveillance) ( ) (active 1 surveillance) () (comparative observational studies) () 臨 (targeted clinical investigations) ( ) (descriptive studies) 說 ()(passive surveillance) () (spontaneous report) ()累 (case series) () (intensified reporting)() (stimulated reporting in the early post-marketing phase) 識 不良 不良療 例 見 不良不易臨 識 例不 不良臨 狀 料不率 例率行 療年 來(systematic methods)來識 例率 Bayesian techniques 識 來 Data mining techniques 累 累 不良 立說 (generating hypotheses)暴露 不良 更不良療 例(anaphylaxis) 不 (aplastic