生物标志物在药品生命周期中的应用与展望

生物标志物(biomarker)是一种能客观测量并评价正常生物过程、病理过程或对药物干预反应的指示物,可有效提高新药研究开发决策,指导候选药物早期临床试验,降低新药研发失败的风险,其在药品生命周期中的重要作用已引起业内普遍关注。欧美等国家和地区相继出台关于生物标志物研究开发和资格鉴定程序的指南,鼓励医药企业将生物标志物作为创新药物发现的工具,在药品上市后通过生物标志物监控其安全性和有效性。本文针对我国药品生命周期特点,对生物标志物在药物基础研究、先导化合物/创新药物的设计与发现、临床前药物开发、临床研究、新药研究及上市后再评价等药品生命周期各个环节中作用情况进行综述,并对其应用前景进行展望。

Identification and application of biomarkers in life cycle of drugs

Biomarkers are defined as a characteristic that is objectively measured and evaluated as an indicator of normal biological processes,pathogenic processes,or pharmacological responses to a therapeutic intervention.Biomarkers can help the decision-making process for new drug research and development,provide guidance for the early clinical development of candidate drugs and reduce the risk of failure.Therefore,as a key factor in the development of new drugs,the discovery and research on biomarkers has increased the interest of the pharmaceutical industry and regulatory agencies.Guidelines on the development and use of biomarkers have been issued by drug regulatory agencies including the EMA,FDA and ICH.Biomarkers are encouraged to be used to facilitate drug development by these relevant regulatory agencies,and also to be used to monitor the safety and efficacy of drugs in post-marketing drug surveillance.The application of biomarkers is encouraged at different stages of a drug’s life cycle,including at the stage of basic science research and target identification,prototype design or discovery,preclinical development,clinical development,FDA filling/approval and launch,as well as post-marketing was reviewed.The identification,development,and application of biomarkers in pharmaceutical research is discussed.