Biomarker Validation: Technological, Clinical and Commercial Aspects

Built on a decade of experience with novel molecular diagnostics, this practice–oriented guide shows how to cope with validation issues during all stages of biomarker development, from the first clinical studies to the eventual commercialization of a new diagnostic test. INDICE: INTRODUCTION.History of Biomarkers.Biomarkers from the Discovery Phase to the Final Assay.Sample Types..IDENTIFICATION OF BIOMARKERS.Overview of Potential Biomarkers.Biomarker Discovery Tools.Academic vs. Industrial Research..CLINICAL STUDIES.Design of Clinical Trials.Guidelines in the US and Europe.Clinical Trials and their Impact on the Validation.Documentation.Ethical Considerations.Epidemiological Aspects..STATISTICS.Different Bioinformatics Approaches.Metadata Analysis and IT based Identification.Quantification: SV, ROC, Thresholds.Standardization..COMMERCIALIZATION.Transfer of Biomarkers between Different Platforms.Treatment of the Low Success Rate.Development of Multi–Parameter Analysis.Obstacles during Commercialization.Approval Procedures..FUTURE OPPURTUNITIES.Specific Biomarkers for Diseases.Platforms with Potentials for Commercialization.Hopes and Fallen Angels.Outlook.

• ISBN: 978-3-527-33719-4
• Editorial: Wiley VCH
• Encuadernacion: Cartoné
• Páginas: 272
• Fecha Publicación: 22/04/2015
• Nº Volúmenes: 1
• Idioma: Inglés