Translating Molecular Biomarkers into Clinical Assays : Techniques and Applications - Weiner, Russell; Kelley, Marian; SpringerLink (Online service) (Cham : Springer International Publishing : Imprint: Springer, 2016)
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. .
Keywords: Pharmaceutical technology; Pharmacy; Pharmaceutical Sciences/Technology.; Pharmacy