摘要
药品质量是决定药品有效性和安全性的基础,关系到患者的治疗结局和生命健康,具有非常重要的意义.药品质量评价的主要目的是了解某种药品的总体质量状况或者比较不同厂家同一通用名药品的质量,从而为医疗机构进行新药遴选或处方集更新及政府决策提供参考.药品质量的评价方式有3种:文献回顾、开展实验室研究、文献回顾联合实验室研究.本章从药品质量层次、药品质量标准、药品上市后质量检查和评价、特定类别或剂型的药物需重点关注的评价项目、说明书、标签及包装等维度介绍了药品质量评价的内容及方法,并提出了药品质量评价技术路线,旨在为开展化学药品和生物制品的质量评价提供参考.
Abstract
The quality of drugs is the basis of their efficacy and safety,thus is closely related to the therapeutic outcome and life and health of patients,having especially important clinical significance.The purpose of drug quality evaluation is mainly to learn the general quality situation of a certain drug or compare the qualities of drugs with the same genetic name manufactured by different companies,thus to provide reference for medical institutions to select pharmaceutical products or update formulary and also for relevant authorities to make decisions.There are three methods to conduct drug quality evaluation:literature review,laboratory experiment,and the combination of literature review and laboratory experiment.This chapter introduces the contents and methods of drug quality evaluation from the perspectives of quality level,quality standard,post-marketing quality supervision and assessment,key evaluation items for drugs of specific classes or dosage forms,package insert,labeling,package,etc.,and proposes the technical route of drug quality evaluation,aiming to provide some ideas for professionals to conduct quality evaluation of chemical drugs and biological products.
NETL
NSTL
万方数据