Development and Validation of Ligand-Binding Assays for Biomarkers

Development and Validation of Ligand-Binding Assays for Biomarkers 

Ligand Binding Assays Development, Validation, and Implementation in the Drug Development Arena. Edited by Masood N. Khan and John W.A. Findlay Copyright 2010 John Wiley Sons, Inc. 

1 New Approaches to Drug Discovery and Development Necessitate New Bioanalytical Approaches 

Many of the bioanalytical principles applied to drug development in the past arose from the diagnostics industry and clinical laboratory sciences. The application of biomarker assays and data in drug development often differs markedly from those approaches, particularly in the case of novel biomarker assays. It is important, therefore, to clarify definitions and use of terms. 

A biomarker is defined as a characteristic that is objectively measured and evaluated as an indicator of normal biological or pathological processes, or pharmacological response to a therapeutic intervention [3]. A clinical end point quantifies a characteristic of a patient s condition (e.g., how they feel or function, or the survival rate of a population) and is used to determine the outcome of a clinical trial. A surrogate end point predicts the safety and efficacy of a drug based on subjective and quantitative data and can be used as a substitute for the clinical end point. 

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DEVELOPMENT AND VALIDATION OF LIGAND BINDING ASSAYS FOR BIOMARKERS... 

This chapter describes the challenges and practical approaches to ligand-binding assays for biomarker quantification. The main points include (1) defining the purpose of the bioanalytical method application, (2) assay development using the appropriate reagents, (3) assay qualification and validation meeting the intended purpose of an assay, and (4) statistical treatments and interpretation. 

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