Translating Molecular Biomarkers into Clinical Assays

1. Fit-for-Purpose Validation
Chad Ray

2. Biomarkers in Drug Discovery and Development: Pre-analytical and Analytical Considerations
R. Aleks Davis, Andrew P. Mayer, Ronald R. Bowsher

3. Biomarker Discovery
Omar F. Laterza, Xuemei Zhao

4. Application of Quantitative Biomeasures in Early Drug Discovery
Scott T. Fountain, Paolo Vicini

5. Biomarkers in Discovery and Preclinical Phase During Drug Development
Jean W. Lee

6. Incorporating Clinical Biomarkers into Clinical Trials
Paul W. Rhyne

7. Perspectives on Tissue Biobanking for Personalized Medicine
Uma Prabhakar

8. The Role of Commercial Biomarker Assay Kits in Preclinical and Clinical Trials
William Nowatzke, Ronald R. Bowsher

9. Quantification of Protein Biomarkers Using Liquid Chromatography Tandem Mass Spectrometry
Hendrik Neubert

10. LC/MS Methods for Small Molecule Biomarkers
Michael P. Sullivan

11. Application of Cell-Based Assays in Clinical Trials
Manjula P. Reddy, Amy Kate Sasser

12. New Technologies for Cellular Analysis
Peter J. O’Brien, Tim Wyant, Virginia Litwin

13. Current Flow Cytometry Methods for the Clinical Development of Immunomodulatory Biologics
Richard Wnek, Michelle Tseng, Dianna Wu

14. Key Mass Spectrometry Techniques Used in Clinical Biomarker Research
Mingxiang Lin

15. Clinical Genomic Biomarker Assay Development: Technologies and Issues
Ken C N Chang, Matthew J. Marton

16. Implementation of Immunohistochemistry Assays for Clinical Trial Sample Analyses
Marisa Dolled-Filhart, Usha Singh, Dianna Wu, K. Emancipator

17. Managing Biomarker Outsourcing: CRO Evaluation, Streamline Outsource Process, and Quality Management
Jeffrey A. Tsou

18. In Situ Hybridization in Clinical Biomarker Development
Usha Singh, Marisa Dolled-Filhart, Dianna Wu

19. Erratum to: Translating Molecular Biomarkers into Clinical Assays
Russell Weiner, Marian Kelley

Keywords: Biomedicine, Pharmaceutical Sciences/Technology, Pharmacy