Biomarkers in drug discovery and development : a handbook of practice, application, and strategy

Biomarkers in drug discovery and development : a handbook of practice, application, and strategy / edited by Ramin Rahbari, Jonathan Van Niewaal, Michael R. Bleavins.

"This book continues the legacy of a well-established reference within the pharmaceutical industry -- providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications t...

Full description

Saved in:
Bibliographic Details
Other Authors: Rahbari, Ramin, 1965- (Editor), Van Niewaal, Jonathan, 1979- (Editor), Bleavins, Michael R. (Editor)
Format: eBook
Language:English
Published: Hoboken, NJ : John Wiley & Sons, Inc., 2020.
Edition:Second edition.
Subjects:
Drug development.
Biochemical markers.
Drugs > Design.
Drugs > Design
Biochemical markers
Drug development
Online Access:Click for online access
Table of Contents:
  • 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, David Adler, 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.
  • 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

Similar Items