Biomarker-based drug safety assessment in the age of systems pharmacology: from foundational to regulatory science

被引：23
|
作者：
Zhang, Chen [1 ]
Hong, Huixiao [2 ]
Mendrick, Donna L. [2 ]
Tang, Yun [1 ]
Cheng, Feixiong [1 ,3 ]
机构：
[1] E China Univ Sci & Technol, Sch Pharm, Shanghai Key Lab New Drug Design, Shanghai 200237, Peoples R China
[2] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA
[3] Sichuan Univ, West China Med Sch, West China Hosp, State Key Lab Biotherapy,Collaborat Innovat Ctr, Chengdu 610041, Peoples R China
来源：
BIOMARKERS IN MEDICINE | 2015年 / 9卷 / 11期
基金：
中国国家自然科学基金;
关键词：
biomarker; drug safety assessment; regulatory science; systems biology; systems pharmacology; IN-SILICO PREDICTION; GENOME-WIDE ASSOCIATION; INDUCED LIVER-INJURY; ENVIRONMENTAL TOXICITY; TARGET IDENTIFICATION; INTERACTION DATABASE; CHEMICAL BIOLOGY; INTEGRATION; DISEASE; MODELS;
D O I：
10.2217/bmm.15.81
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
Improved biomarker-based assessment of drug safety is needed in drug discovery and development as well as regulatory evaluation. However, identifying drug safety-related biomarkers such as genes, proteins, miRNA and single-nucleotide polymorphisms remains a big challenge. The advances of 'omics' and computational technologies such as genomics, transcriptomics, metabolomics, proteomics, systems biology, network biology and systems pharmacology enable us to explore drug actions at the organ and organismal levels. Computational and experimental systems pharmacology approaches could be utilized to facilitate biomarker-based drug safety assessment for drug discovery and development and to inform better regulatory decisions. In this article, we review the current status and advances of systems pharmacology approaches for the development of predictive models to identify biomarkers for drug safety assessment.
引用
收藏
页码：1241 / 1252
页数：12
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