Biomarkers: In Medicine, Drug Discovery, and Environmental Health

Preface xxii

Contributors xxv

1 Biomarkers: An Evolutionary Perspective 1
Michael Ferguson and Vishal Vaidya

Section I: Tools for Biomarker Discovery 5

2 Genomics 7
Weida Tong and Donna L. Mendrick

3 Proteomics for Biomarker Discovery 25
Timothy D. Veenstra

4 Metabolic Profiling for Biomarker Discovery 47
Hector C. Keun

5 The Bittersweet Promise of Glycobiology 75
Padmaparna Chaudhuri, Rania Harfouche, and Shiladitya Sengupta

Section II: Biomarkers of Injury/Disease 89

6 Biomarkers of Alzheimer's and Parkinson's Disease 91 
Walter Maetzler and Daniela Berg

7 Biomarkers of Cardiac Injury 119
Anthony S. McLean and Stephen J. Huang

8 Lung Injury Biomarkers 157
Urmila P. Kodavanti

9 Translational Biomarkers of Acute Drug-Induced Liver Injury: The Current State, Gaps and Future Opportunities 203
Josef Ozer, William Reagan, Sheli Schomaker, Joe Palandra, Mike Baratta and Shashi Ramaiah

10 Biomarkers of Acute Kidney Injury 237
Frank Dieterle and Frank Sistare

11 In Search of Biomarkers for Drug-Induced Vascular Injury 281
James R. Turk

12 Biomarkers of Immunotoxicity 307
Rodney R. Dietert

13 Biomarkers in Obstetric Medicine 323
Manish Maski, Sarosh Rana and S. Ananth Karumanchi

14 Biomarkers in Cancer 355 
Roopali Roy, Christine M. Coticchia, Jiang Yang and Marsha A. Moses

15 Biomarkers of HIV 381
Lewis Kaufman and Michael J Ross

16 Biomarkers of in Vitro Drug-Induced Mitochondrial Dysfunction 401
James A. Dykens and Yvonne Will

Section III: Technology for Biomarker Detection 423

17 Immunoassay-Based Technologies for the Measurement of Biological Materials Used for Biomarkers Discovery and Translational Research 425
Vincent Ricchiuti

18 Nanoscale Techniques for Biomarker Quantification 457
Madhukar Varshney, and Harold G. Craighead

19 Immunodiagnostics with a Focus on Lateral Flow Point-of-Care Devices 495
Roy R. Mondesire, Glen M. Ford, Hannie F. Ford, and Stephen C. Mefferd

Section IV: Hot Topics In Biomarker Research 517

20 Biomarkers for Environmental Exposure 519
Jane E. Gallagher, Elaine A. Cohen Hubal and Stephen W. Edwards

21 Clinical Study Design in Biomarker Research 549
Orfeas Liangos and Bertrand L. Jaber

22 Statistical Issues in Biomarker Research 561
Daniel Holder and Matthew Schipper

23 Regulatory Perspective for Biomarker Qualification from U.S. FDA 581
Federico Goodsaid

24 The European Medicines Agency Approach 589
Marisa Papaluca Amati and Spiros Vamvakas

Index 595