第一章 药品安全性评价指南  

Chapter 1 Guideline for Drug Safety Evaluation

作　　者：赵紫楠[1] 金鹏飞[1] 张亚同[1] 郭代红[2] 胡欣[1] ZHAO Zinan;JIN Pengfei;ZHANG Yatong;GUO Daihong;HU Xin(Department of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China;Department of Pharmacy,Medical Supplies Center,PLA General Hospital,Beijing 100853,China)

机构地区：[1]北京医院药学部国家老年医学中心中国医学科学院老年医学研究院北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730 [2]解放军总医院医疗保障中心药剂科,北京100853

出　　处：《临床药物治疗杂志》2024年第S1期5-8,67,共5页Clinical Medication Journal

摘　　要：药品安全性具有至关重要的意义,其直接关系到患者的健康和生命安全,确保药品在治疗疾病的同时尽可能减少不良反应和潜在风险,是保障公众用药安全有效的核心要素。安全性评价是衡量药品安全性的重要手段,包括对药品上市前的毒理学研究、临床试验阶段的监测,以及上市后的主动、被动监测和风险管理等。通过安全性评价,可以及时发现药品可能存在的安全隐患,如不良反应、药物相互作用等,并采取相应措施加以防范和解决。本章通过全面介绍药品安全性评价维度及对应内容、方法,旨在为开展合理的药品安全性评价提供参考。Drug safety is of crucial significance as it is directly related to the health and safety of patients.Minimizing adverse reactions and potential risks when using drugs to treat diseases is the core element to guarantee the medication safety and effectiveness in the public.Safety evaluation is an important means to measure the safety of drugs,including toxicological studies before the drug is marketed,safety monitoring during the clinical trial stage,as well as active and passive monitoring and risk management after the drug is launched.Through safety evaluation,potential safety hazards of drugs,such as adverse reactions and drug interactions,can be detected in a timely manner,and corresponding measures can be taken to prevent and resolve the hazards.This chapter aims to provide a reference for conducting scientific drug safety evaluations by comprehensively introducing the dimensions of drug safety evaluation and the corresponding contents and methods.

关 键 词：安全性 不良事件 不良反应 风险管理 

分 类 号：R95[医药卫生—药学]