Biomarkers in drug discovery and development : a handbook of practice, application, and strategy /: a handbook of practice, application, and strategy. (2019)

• Record Type: Book
• Further Information: Note: Edited by Ramin Rahbari, Jonathan Van Niewaal, Michael R. Bleavins.
• Editors: Rahbari, Ramin, 1965-; Van Niewaal, Jonathan, 1979-; Bleavins, Michael R
• Contents: List of Contributors vii Preface xiii Part I Biomarkers and Their Role in Drug Development 1 1 Biomarkers are Not New 3; Ian Dews 2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care 15; Gregory J. Downing 3 Enabling Go/No Go Decisions 31; J. Fred Pritchard and M. Lynn Pritchard 4 Developing a Clinical Biomarker Method with External Resources: A Case Study 43; Ross A. Fredenburg Part II Identifying New Biomarkers: Technology Approaches 51 5 Imaging as a Localized Biomarker: Opportunities and Challenges 53; Jonathan B. Moody, Philip S. Murphy, and Edward P. Ficaro 6 Imaging for Early Clinical Drug Development: Integrating Imaging Science with Drug Research 89; Philip S. Murphy, Mats Bergstrom, Jonathan B. Moody, and Edward P. Ficaro 7 Circulating MicroRNAs as Biomarkers in Cardiovascular and Pulmonary Vascular Disease: Promises and Challenges 113; Miranda K. Culley and Stephen Y. Chan Part III Characterization, Validation, and Utilization 139 8 Characterization and Validation of Biomarkers in Drug Development: Regulatory Perspective 141; Federico Goodsaid 9 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development 149; Jean W. Lee, Yuling Wu, and Jin Wang 10 Applying Statistics Appropriately for Your Biomarker Application 177; Mary Zacour Part IV Biomarkers in Discovery and Preclinical Safety 219 11 Qualification of Safety Biomarkers for Application to Early Drug Development 221; William B. Mattes and Frank D. Sistare 12 A Pathologist’s View of Drug and Biomarker Development 233; Robert W. Dunstan 13 Development of Serum Calcium and Phosphorus as Safety Biomarkers for Drug-Induced Systemic Mineralization: Case Study with the MEK Inhibitor PD0325901 255; Alan P. Brown 14 New Markers of Kidney Injury 281; Sven A. Beushausen Part V Translating from Preclinical to Clinical and Back 307 15 Biomarkers from Bench to Bedside and Back – Back-Translation of Clinical Studies to Preclinical Models 309; Damian O’Connell, Zaki Shaikhibrahim, Frank Kramer, and Matthias Ocker 16 Translational Medicine – A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers 333; Giora Z. Feuerstein, Salvatore Alesci, Frank L.Walsh, J. Lynn Rutkowski, and Robert R. Ruffolo Jr. 17 Clinical Validation and Biomarker Translation 347; Ji-Young V. Kim, Raymond T. Ng, Robert Balshaw, Paul Keown, Robert McMaster, Bruce McManus, Karen Lam, and Scott J. Tebbutt 18 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis 365; Christina Trollmo and Lars Klareskog 19 Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints 379; Calvert Louden and Ruth A. Roberts Part VI Biomarkers in Clinical Trials 389 20 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: A Case Study in Anticoagulant Development 391; Kay A. Criswell 21 Integrating Molecular Testing into Clinical Applications 409; Anthony A. Killeen Part VII Big Data, Data Mining, and Biomarkers 421 22 IT Supporting Biomarker-Enabled Drug Development 423; Michael Hehenberger 23 Identifying Biomarker Profiles Through the Epidemiologic Analysis of Big Health Care Data – Implications for Clinical Management and Clinical Trial Design: A Case Study in Anemia of Chronic Kidney Disease 447; Gregory P. Fusco 24 Computational Biology Approaches to Support Biomarker Discovery and Development 469; Bin Li, Hyunjin Shin, William L. Trepicchio, and Andrew Dorner Part VIII Lessons Learned: Practical Aspects of Biomarker Implementation 485 25 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork 487; Lena King, Mallé Jurima-Romet, and Nita Ichhpurani 26 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices 505; Bruce D. Car, Brian Gemzik, and William R. Foster Part IX Where are We Heading and What Do We Really Need? 515 27 Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection 517; Sara Assadian, Michael Burgess, Breanne Crouch, Karen Lam, and Bruce McManus 28 Anti-Unicorn Principle: Appropriate Biomarkers Don’t Need to Be Rare or Hard to Find 537; Michael R. Bleavins and Ramin Rahbari 29 Translational Biomarker Imaging: Applications, Trends, and Successes Today and Tomorrow 553; Patrick McConville and Deanne Lister Index 585
• Edition: 2nd edition
• Publisher Details: Hoboken, New Jersey : John Wiley & Sons, Inc
• Publication Date: 2019
• Extent: 1 online resource
• Subjects: 615.19; Biochemical markers; Drug development
• Languages: English
• ISBNs: 9781119187523
• Related ISBNs: 9781119187516
• Notes: Note: Description based on CIP data; resource not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.