Abstract

In the context of nonclinical drug development, a biomarker may be defined as any specific parameter that is objectively measured and evaluated as an indicator of normal biological processes, pathologic processes, or pharmacologic responses to a drug or test article, which helps to diagnose/monitor a disease and/or outcome of therapeutic intervention. The use of biomarkers in nonclinical drug development covers a broad range of disciplines, modalities, and development stages ranging from identification and assessment of drug targets to issue resolution during the clinical trial of investigative drugs. Biomarkers became more applicable in drug development after the complete sequencing of the human genome and the expansion of omics technologies that followed. The use of traditional and contemporary biomarkers has been presented in the major organ systems, including hepatobiliary, renal, cardiac, muscular, reproductive, nervous, and immune systems. Understanding the comparative physiology and dynamics of each biomarker is vital to its contextual application.

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