Biomarker-based drug safety assessment in the age of systems pharmacology: from foundational to regulatory science.
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.
Shanghai Key Laboratory of New Drug Design, School of Pharmacy, East China University of Science & Technology, 130 Meilong Road, Shanghai 200237, China.
Chen
C
Zhang
National Center for Toxicological Research, US Food & Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA.
Huixiao
H
Hong
National Center for Toxicological Research, US Food & Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA.
Donna L
DL
Mendrick
Shanghai Key Laboratory of New Drug Design, School of Pharmacy, East China University of Science & Technology, 130 Meilong Road, Shanghai 200237, China.
Yun
Y
Tang
Shanghai Key Laboratory of New Drug Design, School of Pharmacy, East China University of Science & Technology, 130 Meilong Road, Shanghai 200237, China.|State Key Laboratory of Biotherapy/Collaborative Innovation Center for Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu 610041, Sichuan, China.
Feixiong
F
Cheng
D000818:Animals; D054316:Biomarkers, Pharmacological / Q000378:metabolism*; D006801:Humans; D004364:Pharmaceutical Preparations; D010600:Pharmacology / Q000379:methods*; D012449:Safety; D012926:Social Control, Formal; D049490:Systems Biology / Q000379:methods*
D054316:Biomarkers, Pharmacological; D004364:Pharmaceutical Preparations
biomarker; drug safety assessment; regulatory science; systems biology; systems pharmacology