摘要
生物标志物通常是指能被客观测量和评价,反映生理或病理过程,以及对药物暴露或治疗干预措施产生生物学效应的指标。随着对肿瘤发生发展的病理生理机制研究的不断深入,越来越多与肿瘤进展和复发相关的生物标志物被相继发现,并在肿瘤早期诊断、筛选人群、剂量优化、指导用药、疗效评估和预测预后等方面发挥重要作用,有效提高了肿瘤药物研发的成功率。因此,寻找和发现有价值的生物标志物已经成为目前抗肿瘤药物研发的热点。本文系统阐述生物标志物定义,功能分类,重点说明生物标志物在抗肿瘤药物研发中的应用,明确基于生物标志物的临床研发中需重点关注的科学问题,以期为药物研发的相关人员提供参考。
Biomarkers typically refer to indicators that can be objectively measured and evaluated,reflecting physiological or pathological processes,and having biological effects on drug exposure or therapeutic interventions.With the development of the research on the pathophysiological mechanism of tumor,more and more biomarkers have been discovered,which related to tumor progression and recurrence.They play an important role in early tumor diagnosis,screening populations,dose optimization,guiding medication,efficacy evaluation,prognosis,and prediction,that effectively improve the success rate of tumor drug development.Searching and discovering valuable biomarkers has become a hot spot in the research and development of anti-cancer drugs.This article systematically expounds the definition,and classification of biomarkers,focuses on the application of biomarkers in the research and development of anti-cancer drugs,and defines the scientific issues that need to be paid attention to in clinical research and development based on biomarkers,to provide reference for the industry.
作者
宋媛媛
夏琳
郝瑞敏
齐玥丽
杨志敏
SONG Yuan-yuan;XIA Lin;HAO Rui-min;QI Yue-li;YANG Zhi-min(Center for Drug Evaluation,China National Medical Products Administration,Beijing 100022,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2022年第21期2652-2656,共5页
The Chinese Journal of Clinical Pharmacology
关键词
生物标志物
抗肿瘤药物
临床研发
biomarkers
anti-cancer drug
clinical research and development
