{"product_id":"biomarkers-in-drug-discovery-and-development-9781119187509","title":"Biomarkers in Drug Discovery and Development","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eThis 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.\u003c\/p\u003e \u003cul\u003e \u003cli\u003eExplains 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\u003c\/li\u003e \u003cli\u003eHelps 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\u003c\/li\u003e \u003cli\u003eUpdates 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\u003c\/li\u003e \u003cli\u003eIncludes \u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eList of Contributors vii\u003c\/p\u003e \u003cp\u003ePreface xiii\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Biomarkers and Their Role in Drug Development \u003c\/b\u003e\u003cb\u003e1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1 Biomarkers are Not New 3\u003cbr\u003e\u003ci\u003eIan Dews\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care 15\u003cbr\u003e\u003ci\u003eGregory J. Downing\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Enabling Go\/No Go Decisions 31\u003cbr\u003e\u003ci\u003eJ. Fred Pritchard and M. Lynn Pritchard\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Developing a Clinical Biomarker Method with External Resources: A Case Study 43\u003cbr\u003e\u003ci\u003eRoss A. Fredenburg\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Identifying New Biomarkers: Technology Approaches \u003c\/b\u003e\u003cb\u003e51\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5 Imaging as a Localized Biomarker: Opportunities and Challenges 53\u003cbr\u003e\u003ci\u003eJonathan B. Moody, Philip S. Murphy, and Edward P. Ficaro\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Imaging for Early Clinical Drug Development: Integrating Imaging Science with Drug Research 89\u003cbr\u003e\u003ci\u003ePhilip S. Murphy, Mats Bergstrom, Jonathan B. Moody, and Edward P. Ficaro\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Circulating MicroRNAs as Biomarkers in Cardiovascular and Pulmonary Vascular Disease: Promises and Challenges 113\u003cbr\u003e\u003ci\u003eMiranda K. Culley and Stephen Y. Chan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Characterization, Validation, and Utilization \u003c\/b\u003e\u003cb\u003e139\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8 Characterization and Validation of Biomarkers in Drug Development: Regulatory Perspective 141\u003cbr\u003e\u003ci\u003eFederico Goodsaid\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development 149\u003cbr\u003e\u003ci\u003eJean W. Lee, Yuling Wu, and Jin Wang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Applying Statistics Appropriately for Your Biomarker Application 177\u003cbr\u003e\u003ci\u003eMary Zacour\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IV Biomarkers in Discovery and Preclinical Safety \u003c\/b\u003e\u003cb\u003e219\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11 Qualification of Safety Biomarkers for Application to Early Drug Development 221\u003cbr\u003e\u003ci\u003eWilliam B. Mattes and Frank D. Sistare\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 A Pathologist’s View of Drug and Biomarker Development 233\u003cbr\u003e\u003ci\u003eRobert W. Dunstan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Development of Serum Calcium and Phosphorus as Safety Biomarkers for Drug-Induced Systemic Mineralization: Case Study with the MEK Inhibitor PD0325901 255\u003cbr\u003e\u003ci\u003eAlan P. Brown\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 New Markers of Kidney Injury 281\u003cbr\u003e\u003ci\u003eSven A. Beushausen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart V Translating from Preclinical to Clinical and Back 307\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15 Biomarkers from Bench to Bedside and Back – Back-Translation of Clinical Studies to Preclinical Models 309\u003cbr\u003e\u003ci\u003eDamian O'Connell, David Adler, Frank Kramer, and Matthias Ocker\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16 Translational Medicine – A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers 333\u003cbr\u003e\u003ci\u003eGiora Z. Feuerstein, Salvatore Alesci, Frank L.Walsh, J. Lynn Rutkowski, and Robert R. Ruffolo Jr.\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17 Clinical Validation and Biomarker Translation 347\u003cbr\u003e\u003ci\u003eJi-Young V. Kim, Raymond T. Ng, Robert Balshaw, Paul Keown, Robert McMaster, Bruce McManus, Karen Lam, and Scott J. Tebbutt\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis 365\u003cbr\u003e\u003ci\u003eChristina Trollmo and Lars Klareskog\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19 Validating \u003ci\u003eIn Vitro \u003c\/i\u003eToxicity Biomarkers Against Clinical Endpoints 379\u003cbr\u003e\u003ci\u003eCalvert Louden and Ruth A. Roberts\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart VI Biomarkers in Clinical Trials 389\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e20 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: A Case Study in Anticoagulant Development 391\u003cbr\u003e\u003ci\u003eKay A. Criswell\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21 Integrating Molecular Testing into Clinical Applications 409\u003cbr\u003e\u003ci\u003eAnthony A. Killeen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart VII Big Data, Data Mining, and Biomarkers 421\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e22 IT Supporting Biomarker-Enabled Drug Development 423\u003cbr\u003e\u003ci\u003eMichael Hehenberger\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23 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\u003cbr\u003e\u003ci\u003eGregory P. Fusco\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24 Computational Biology Approaches to Support Biomarker Discovery and Development 469\u003cbr\u003e\u003ci\u003eBin Li, Hyunjin Shin, William L. Trepicchio, and Andrew Dorner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart VIII Lessons Learned: Practical Aspects of Biomarker Implementation 485\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e25 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork 487\u003cbr\u003e\u003ci\u003eLena King, Mallé Jurima-Romet, and Nita Ichhpurani\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices 505\u003cbr\u003e\u003ci\u003eBruce D. Car, Brian Gemzik, and William R. Foster\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IX Where are We Heading and What Do We Really Need? 515\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e27 Ethics of Biomarkers: The Borders of Investigative Research, Informed Consent, and Patient Protection 517\u003cbr\u003e\u003ci\u003eSara Assadian, Michael Burgess, Breanne Crouch, Karen Lam, and Bruce \u003c\/i\u003e\u003ci\u003eMcManus\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e28 Anti-Unicorn Principle: Appropriate Biomarkers Don't Need to Be Rare or Hard to Find 537\u003cbr\u003e\u003ci\u003eMichael R. Bleavins and Ramin Rahbari\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e29 Translational Biomarker Imaging: Applications, Trends, and Successes Today and Tomorrow 553\u003cbr\u003e\u003ci\u003ePatrick McConville and Deanne Lister\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 585\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":51769056788823,"sku":"9781119187509","price":170.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781119187509.jpg?v=1758719484","url":"https:\/\/bookcurl.com\/products\/biomarkers-in-drug-discovery-and-development-9781119187509","provider":"Book Curl","version":"1.0","type":"link"}