Chapter 1 Introduction

Sadana, Ajit; Sadana, Neeti

Abstract A biomarker may refer to a protein whose concentration refers to the severity or presence of some disease state. These biomarkers may be detectable and measurable by a variety of methods including physical examination, laboratory assays, and medical imaging. College Hill indicates that “Biomarkers are valued tools used across the biological spectrum from research to diagnostics, as indicators of normal or disease processes to assess pharmacological responses.” Biomarker (biological marker) is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic response to a therapeutic intervention. Biomarkers are proposed to measure the delivery of drugs to their intended targets, and to understand and predict pathophysiology, and how it is altered by therapy, through monitoring variables known to have chemical relevance. The intent is to use biomarkers for their predictive power to select compounds and design dosing regimens for meeting the pharmacokinetic criteria for a new drug.