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Biomarkers in drug discovery and development : a handbook of practice, application, and strategy /
"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...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, NJ :
John Wiley & Sons, Inc.,
2020.
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| Edición: | Second edition. |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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