Translating Molecular Biomarkers into Clinical Assays

Foreword.- Fit-For-Purpose Validation.- Biomarkers in Drug Discovery and Development: Pre-Analytical and Analytical Considerations.- Biomarker Discovery.- Application of Quantitative Biomeasures in Early Drug Discovery.- Biomarkers in discovery and preclinical phase during drug development.- Incorporating clinical biomarkers into clinical trials.- Perspectives on Tissue Biobanking for Personalized Medicine.- The role of commercial biomarker assay kits in preclinical and clinical trials kits.- Quantification of protein biomarkers using liquid chromatography tandem mass spectrometry.- LC/MS methods for small Molecule biomarkers.- Cell-based Assays.- New Technologies for Cellular Analysis.- Flow cytometry methods for the Clinical Development of Immunomodulatory Biologics.- Key mass spectrometry techniques used in clinical biomarker research.- Clinical Genomic Biomarker Assay Development: Technologies and Issues.- Implementation of Immunohistochemistry assays for clinical trial sample analyses.- Strategic Approach to Outsourcing Clinical Biomarker Assays through CRO Relationships.- In situ hybridization (ISH) in Clinical Biomarker Development.

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Biomarker;pharmacokinetics;FDA;bioanalysis;target engagement