Biomarkers navigate drug development: Pharmacology, effectiveness and safety

Abstract

Recent decades have witnessed a paradigm shift from traditional therapy to precision medicine, which was substantially facilitated by implementing biomarker strategy. Taking the advantages of contemporary biological sciences and advanced technology, novel biomarkers are increasingly identified and validated in numerous aspects of pharmaceutical development, thus leading to the success of emerging medications for unmet clinical needs. Herein, this article presents a comprehensive update on evolving trends of biomarkers in the field, covering the applied pharmacology, therapeutic guidance/monitoring, patient stratification, toxicity detection, among others. In this light, it tends not only to improve the efficiency of drug development and the outcome of medical care, but also to optimize the entire life cycle assessment of pharmaceutical products.

Keywords

• Biomarker
• Drug development
• Clinical trial design