‏1,256.00 ₪

Biomarkers in Drug Discovery and Development: A Ha ndbook of Practice, Application, and Strategy, Se

‏1,256.00 ₪
ISBN13
9781119187509
יצא לאור ב
Hoboken
מהדורה
2nd Edition
זמן אספקה
21 ימי עסקים
עמודים
608
פורמט
Hardback
תאריך יציאה לאור
10 בינו׳ 2020
מחליף את פריט
14516927000
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 throughout drug discovery and development. - Explains where proper use of biomarkers can substantively impact drug development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine - Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory - Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring - Includes case studies of biomarkers that have helped and hindered decision making - Reviews of the first edition: "If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn't be, then this book is for you." (ISSX) and "...provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation." (ChemMedChem)
מידע נוסף
מהדורה 2nd Edition
עמודים 608
מחליף את פריט 14516927000
פורמט Hardback
ISBN10 1119187508
יצא לאור ב Hoboken
תאריך יציאה לאור 10 בינו׳ 2020
תוכן עניינים List of Contributors ix Preface Part I Biomarkers and Their Role in Drug Development x 1 Biomarkers Are Not New x Ian Dews 2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care x Gregory J. Downing 3 Enabling Go/No Go Decisions x J. Fred Pritchard and M. Lynn Pritchard 4 Developing a Clinical Biomarker Method with External Resources: A Case Study x Ross A. Fredenburg Part II Biomarker Technologies x 5 Imaging as a Localized Biomarker: Opportunities and Challenges x Jonathan B. Moody, Philip S. Murphy, and Edward P. Ficaro 6 Imaging for Early Clinical Drug Development: Integrating Imaging Science With Drug Research x 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 x Miranda K. Culley and Stephen Y. Chan Part III Characterization, Validation, and Utilization x 8 Characterization and Validation Biomarkers in Drug Development: Regulatory Perspective x Federico Goodsaid 9 Fit-for-Purpose Method Validation and Assays of Protein Biomarkers During Drug Development x Jean W. Lee, Yuling Wu, and Jin Wang 10 Applying Statistics Appropriately for Your Biomarker Application x Mary Zacour Part IV Biomarkers in Discovery and Preclinical Safety x 11 Qualification of Safety Biomarkers for Application to Early Drug Development x William B. Mattes and Frank D. Sistare 12 A Pathologist's View of Drug and Biomarker Development x Robert W. Dunstan 13 Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor x Alan P. Brown 14 New Markers of Kidney Injury x Sven A. Beushausen Part V Translating from Preclinical to Clinical and Back x 15 Biomarkers from Bench to Bedside and Back - Back Translation of Clinical Studies to Pre-clinical Models x 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 x Giora Z. Feuerstein, Salvatore Alesci, Frank L. Walsh, J. Lynn Rutkowski, and Robert R. Ruffolo, Jr. 17 Clinical Validation and Biomarker Translation x 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 x Christina Trollmo and Lars Klareskog 19 Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints x Calvert Louden and Ruth A. Roberts Part VI Biomarkers in Clinical Trials x 20 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: Case Study in Anticoagulant Development x Kay A. Criswell 21 Integrating Molecular Testing into Clinical Applications x Anthony A. Killeen Part VII Big Data, Data Mining and Biomarkers x 22 IT Supporting Biomarker Enabled Drug Development x Michael Hehenberger 23 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 x Gregory P. Fusco 24 Computational Biology Approaches to Support Biomarker Discovery and Development xq Bin Li, Hyunjin Shin, William L. Trepiccho, and Andrew Dorner Part VIII Lessons Learned: Practical Aspects of Biomarker Implementation X 25 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork x Lena King, Malle Jurima-Romet, and Nita Ichhpurani 26 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices x Bruce D. Car, Brian Gemzik, and William R. Foster Part IX Where Are We Heading and What Do We Really Need? x 27 Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection x 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 x Michael R. Bleavins and Ramin Rahbari 29 Translational Biomarker Imaging: Applications, Trends and Successes Today and Tomorrow x Patrick McConville and Deanne Lister Index x
זמן אספקה 21 ימי עסקים