This book focuses on proteomics biomarker discovery and validation procedures from the clinical perspective. It provides an overview of current technology and the challenges encountered throughout the process. This covers all key stages, from biomarker discovery and validation, through to registration with the European and US regulatory authorities (EMEA and FDA). All the important elements (such as patient selection, sample handling, data processing, and statistical analysis) are described in detail and the reader is introduced to each topic with well described examples or guidelines for best practice. Case studies are also included to demonstrate clinical applications. Individual chapters explain the best performing techniques for profiling complex body fluids and biomarker discovery. This includes the application of different LC-MS profiling platforms and affinity array for screening complex body fluids. Future developments needed to improve the success rate of translating biomarker discovery into useful clinical tests are also discussed. Common pitfalls and success stories are described as are the limitations of the various technologies involved. Broad and interdisciplinary in approach, this book provides an excellent source of information for industrial and academic researchers.

Peter Horvatovich and Rainer Bischoff have worked at the University of Groningen Faculty of Mathematics and Natural Science for more than five years. Rainer Bischoff is professor in analytical biochemistry and has been studying protein analysis and proteomics for over 20 years. He obtained his PhD at the University of G÷ttingen before undertaking postdoctoral research at Purdue University in the USA. He also worked as a group and project leader at Transgene S. A. in Strasburg and a section manager at AstraZeneca R&D in Lund. Peter Horvatovich is an Assistant Professor. He has studied proteomics related bioinformatics for more than eight years and has an analytical chemistry background. Dr Horvatovich received his PhD at the University of Strasbourg for work related to the detection of irradiated food. He then worked at Sanofi-Synthelabo in Budapest and as a postdoctoral researcher at the Bundesinstitute für Risikobewertung in Berlin before moving to the University of Groningen.

Introduction to biomarker discovery and validation; Clinical context of proteomics biomarker discovery and validation, authority regulations; Biomarker discovery: Patient selection; Biomarker discovery: Experimental design and biobanking; Biomarker discovery: body fluids; Biomarker discovery: tissues; Biomarker discovery: mass spectrometry based profiling platforms; Biomarker discovery: array based profiling platforms; Biomarker discovery: data preprocessing for LC-MS data; Biomarker discovery: data preprocessing for Maldi imaging, and 2D electrophoresis and protein arrays data; Biomarker discovery: statistical analysis and validation; Biomarker validation: biomarker validation methods; Functional biomarker validation; Clinical application: case studies Clinical application: summary and future technology development trends