生物标志物在生物药临床研究中的应用及生物分析策略

doi:10.12092/j.issn.1009-2501.2020.01.004

摘要/Abstract

摘要： 中国生物药研发进入快车道，新药研发费用不断攀升，但并没有提高药物上市的成功率，因此亟需对药物研发模式进行转变。为了提高药物研发成功率，以生物标志物为核心的转化医学新药研发模式被普遍接受。本文综述了以生物标志物为核心的转化医学新药研发思路，生物标志物在生物药临床研究中的应用，生物标志物生物分析策略，生物标志物在生物药临床研究中的机遇与挑战。通过对标国际，寻找中国优势，从生物标志物为立足点的转化医学研发模式寻找机遇，中国可以尽早做成具有全球影响力的创新药。

关键词: 生物药, 生物标志物, 临床研究, 转化医学, 生物分析

Abstract: China's biologic drug research and development is on a fast track lane. The rising cost of new drug development has not improved the success rate of drug launch, and a shift in the model of drug development is urgently needed. In order to improve the success rate, a biomarker strategy of the new drug development model has been proposed and is generally accepted. This paper reviews the research and development of new translational medicine drugs with biomarkers as the core, the application of biomarkers in the clinical study of biological drugs, biomarker biological analysis strategies, and the opportunities and challenges of biomarkers in the clinical study of biological drugs. By comparing international standards, seeking China's advantages and seeking opportunities from the research and development model of translational medicine based on biomarkers, China can make innovative drugs with global influence in the near term.

Key words: biological drugs, biomarkers, clinical research, translational medicine, bioanalysis

中图分类号:

R915

车津晶. 生物标志物在生物药临床研究中的应用及生物分析策略[J]. 中国临床药理学与治疗学, 2020, 25(1): 22-31.

CHE Jinjing. Application of biomarkers in clinical development of biologics and bioanalytical strategies[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(1): 22-31.

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