An Overview on the Third Annual Pharmacovigilance Forum

I. Magyar
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引用次数: 8

Abstract

Pharmacovigilance is the fourth steps (the last phase) in clinical development of the drugs –after the drug is marketed. New prescription drugs are only marketed after carefully controlled clinical trials have shown them to be safe and effective. Farmacovigilance is the postmarketing surveillance and study of ADRs, with the ultimate goal of preventing or minimizing their occurrence. It is a continuous process that involve both health authorities and pharmaceutical industry. It is a necessary interface between therapeutics and clinical epidemiology. The costs (billions of dollars annually) includes collection, compilation, quality control, and analysis of the spontaneus reports. Although it is the ′′poor relative′′ of pharmacology and the ′′bogeyman′′ of the sellers of new drugs, pharmacovigilance is, neverthless, very important component for the rational use of drugs [1-3].
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第三届年度药物警戒论坛综述
药物警戒是药物上市后临床开发的第四步(最后一个阶段)。新的处方药只有在经过严格控制的临床试验证明其安全有效后才会上市。药物警戒是对药品不良反应的上市后监测和研究,其最终目标是预防或尽量减少其发生。这是一个涉及卫生当局和制药工业的持续过程。它是治疗学和临床流行病学之间的必要接口。成本(每年数十亿美元)包括收集、汇编、质量控制和分析自发报告。虽然是药理学的“穷亲戚”,是新药销售商的“妖怪”,但药物警戒却是合理用药的重要组成部分[1-3]。
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