当前"以患者为中心"的药物研发(patient focused drug development,PFDD)理念被制药行业和各国监管机构广泛接纳并应用到临床研发的各个阶段,且逐渐扩展到药学研发中.在此基础上,"以患者为中心的质量标准"(patient-centric specifications,PCS)应运而生.PCS是一种基于科学和风险的质量标准制定办法,侧重于质量属性对患者安全性和有效性影响的风险评估,确定与临床相关的可接受范围,从而为患者提供符合预期的药品,尽可能提高患者的临床获益.PCS建立在大量的知识经验积累和全生命周期管理基础之上.本文将围绕对质量标准的理解,探讨PCS在治疗类生物制品中的应用.
Establishing patient-centric specifications for therapeutic biological products
Currently,the concept of"patient focused drug development(PFDD)"has been widely accepted by the pharmaceutical industry and regulatory agencies in various countries and applied in each stages of clinical research and development,which was further extended to pharmaceutical research and development gradually.On this basis,patient-centric specifications(PCS)has emerged,which is a science-and risk-based approach to specifications setting.It focuses on risk assessment of the impact of quality attributes on patient safety and efficacy,and determines clinically relevant acceptable ranges in order to provide the patients with expected medicines that maximize clinical benefit.PCS was built on the basis of extensive knowledge and experience,as well as the whole life cycle management.This article focuses on the understanding of specifications and discusses the application of"patient-centric specifications"in therapeutic biological products.
patient focused drug developmentpatient-centric specificationscritical quality attributelife-cycle managementtherapeutic biological products
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