Establishing patient-centric specifications for therapeutic biological products
LI Yi-jun
WEI Kai-kun
Abstract：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.
Keywords：patient focused drug developmentpatient-centric specificationscritical quality attributelife-cycle managementtherapeutic biological products
Publication Date：2024-12-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 2438-2445 )