.

0 (hodnocen0 x )

EB

ONLINE

Second edition

Hoboken, New Jersey : Wiley, 2020

1 online resource (611 pages)

ISBN 9781119187516 (e-book)

ISBN 9781119187509

Print version: Biomarkers in drug discovery and development : a handbook of practice, application, and strategy. Second edition. Hoboken, New Jersey : Wiley, 2020 611 pages ISBN 9781119187509

Preceded by Biomarkers in drug development : a handbook of practice, application, and strategy / edited by Michael R. Bleavins ... [et al.], 2010

Includes bibliographical references and index

Clinical Validation and Biomarker Translation / Ji-Young V. Kim, Raymond T. Ng, Robert Balshaw, Paul Keown, Robert McMaster, Bruce McManus, Karen Lam, and Scott J. Tebbutt -- Predicting and Assessing an Inflammatory Disease and Its Complications : Example from Rheumatoid Arthritis / Christina Trollmo and Lars Klareskog -- Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints / Calvert Louden and Ruth A. Roberts -- Opportunities and Pitfalls Associated with Early Utilization of Biomarkers : Case Study in Anticoagulant Development / Kay A. Criswell -- Integrating Molecular Testing into Clinical Applications / Anthony A. Killeen -- IT Supporting Biomarker Enabled Drug Development / Michael Hehenberger -- Identifying Biomarker Profiles Through the Epidemiologic Analysis of Big Healthcare Data Implications for Clinical Management and Clinical Trial Design : A Case Study in Anemia of Chronic Kidney Disease / Gregory P. Fusco -- Computational Biology Approaches to Support Biomarker Discovery and Development / Bin Li, Hyunjin Shin, William L. Trepiccho, and Andrew Dorner -- Biomarkers in Pharmaceutical Development : The Essential Role of Project Management and Teamwork / Lena King, Malle Jurima-Romet, and Nita Ichhpurani -- Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices / Bruce D. Car, Brian Gemzik, and William R. Foster -- Ethics of Biomarkers : The Borders of Investigative Research, Informed Consent, and Patient Protection / Sara Assadian, Michael Burgess, Breanne Crouch, Karen Lam, and Bruce McManus -- Anti-Unicorn Principle : Appropriate Biomarkers Don’t Need to Be Rare or Hard to Find / Michael R. Bleavins and Ramin Rahbari -- Translational Biomarker Imaging : Applications, Trends and Successes Today and Tomorrow / Patrick McConville and Deanne Lister --.

Biomarkers Are Not New / Ian Dews -- Biomarkers : Facing the Challenges at the Crossroads of Research and Health Care / Gregory J. Downing -- Enabling Go/No Go Decisions / J. Fred Pritchard and M. Lynn Pritchard -- Developing a Clinical Biomarker Method with External Resources : A Case Study / Ross A. Fredenburg -- Imaging as a Localized Biomarker : Opportunities and Challenges / Jonathan B. Moody, Philip S. Murphy, and Edward P. Ficaro -- Imaging for Early Clinical Drug Development : Integrating Imaging Science With Drug Research / Philip S. Murphy, Mats Bergstrom, Jonathan B. Moody, and Edward P. Ficaro -- Circulating microRNAs as Biomarkers in Cardiovascular and Pulmonary Vascular Disease : Promises and Challenges / Miranda K. Culley and Stephen Y. Chan -- Characterization and Validation Biomarkers in Drug Development : Regulatory Perspective / Federico Goodsaid -- Fit-for-Purpose Method Validation and Assays of Protein Biomarkers During Drug Development / Jean W. Lee, Yuling Wu, and Jin Wang -- Applying Statistics Appropriately for Your Biomarker Application / Mary Zacour -- Qualification of Safety Biomarkers for Application to Early Drug Development / William B. Mattes and Frank D. Sistare -- A Pathologist’s View of Drug and Biomarker Development / Robert W. Dunstan -- Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization : Case Study with a MEK Inhibitor / Alan P. Brown -- New Markers of Kidney Injury / Sven A. Beushausen -- Biomarkers from Bench to Bedside and Back -- Back Translation of Clinical Studies to Pre-clinical Models / Damian O’Connell, Zaki Shaikhibrahim, Frank Kramer, and Matthias Ocker -- Translational Medicine -- A Paradigm Shift in Modern Drug Discovery and Development : The Role of Biomarkers / Giora Z. Feuerstein, Salvatore Alesci, Frank L. Walsh, J. Lynn Rutkowski, and Robert R. Ruffolo, Jr. --.

001888353

full

(Au-PeEL)EBL6126007

(MiAaPQ)EBC6126007

(OCoLC)1143646514