Biomarkers in drug development: a handbook of practice, application, and strategy
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
Hoboken, N.J.
Wiley
2010
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | XVII, 744 S. Ill., graph. Darst. 25 cm |
| ISBN: | 9780470169278 0470169273 |
Staff View
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| 245 | 1 | 0 | |a Biomarkers in drug development |b a handbook of practice, application, and strategy |c ed. by Michael R. Bleavins ... |
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| 650 | 4 | |a Biomarkers, Pharmacological | |
| 650 | 4 | |a Drug Design | |
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Record in the Search Index
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| adam_text | Titel: Biomarkers in drug development
Autor: Bleavins, Michael R.
Jahr: 2010
CONTENTS
CONTRIBUTORS ix
PREFACE xv
PART I BIOMARKERS AND THEIR ROLE IN DRUG
DEVELOPMENT 1
1 Biomarkers Are Not New 3
Ian Dews
2 Biomarkers: Facing the Challenges at the Crossroads of
Research and Health Care 15
Gregory J. Downing
3 Enabling Go/No Go Decisions 31
J. Fred Pritchard and Matte Jurima-Romet
PART II IDENTIFYING NEW BIOMARKERS:
TECHNOLOGY APPROACHES 41
4 Imaging as a Localized Biomarker: Opportunities and Challenges 43
Jonathan B. Moody, Philip S. Murphy, and Edward P. Ficaro
5 Protein Biomarker Discovery Using Mass Spectrometry-
Based Proteomics 101
Joanna M. Hunter and Daniel Chelsky
6 Quantitative Multiplexed Patterning of Immune-
Related Biomarkers 121
Dominic Eisinger, Ralph McDade, and Thomas Joos
vi CONTENTS
7 Gene Expression Profiles as Preclinical and Clinical Cancer
Biomarkers of Prognosis, Drug Response, and Drug Toxicity 135
Jason A. Sprowl and Amadeo M. Parissenti
8 Use of High-Throughput Proteomic Arrays for the Discovery
of Disease-Associated Molecules 155
Douglas M. Molina, W. John W. Morrow, and Xiaowu Liang
PART III CHARACTERIZATION AND VALIDATION 177
9 Characterization and Validation Biomarkers in Drug
Development: Regulatory Perspective 179
Federico Goodsaid
10 Fit-for-Purpose Method Validation and Assays for Biomarker
Characterization to Support Drug Development 187
Jean W. Lee, Yuling Wu, and Jin Wang
11 Molecular Biomarkers from a Diagnostic Perspective 215
Klaus Lindpaintner
12 Strategies for the Co-Development of Drugs and Diagnostics:
FDA Perspective on Diagnostics Regulation 231
Francis Kalush and Steven Gutman
13 Importance of Statistics in the Qualification and Application
of Biomarkers 247
Mary Zacour
PART IV BIOMARKERS IN DISCOVERY AND
PRECLINICAL SAFETY 287
14 Qualification of Safety Biomarkers for Application to
Early Drug Development 289
William B. Mattes and Frank D. Sistare
15 Development of Serum Calcium and Phosphorus as Clinical
Biomarkers for Drug-Induced Systemic Mineralization:
Case Study with a MEK Inhibitor 301
Alan P. Brown
16 Biomarkers for the Immunogenicity of Therapeutic Proteins
and Its Clinical Consequences 323
Claire Cornips and Huub Schellekens
17 New Markers of Kidney Injury 335
Sven A. Beushausen
CONTENTS Vll
PART V TRANSLATING FROM PRECLINICAL RESULTS
TO CLINICAL AND BACK 359
18 Translational Medicine?A Paradigm Shift in Modern Drug
Discovery and Development: The Role of Biomarkers 361
Giora Z. Feuerstein, Salvatore Alesci, Frank L. Walsh,
J. Lynn Rutkowski, and Robert R. Ruffolo, Jr.
19 Clinical Validation and Biomarker Translation 375
David Lin, Andreas Scherer, Raymond Ng, Robert Balshaw,
Shawna Flynn, Paul Keown, Robert McMaster, and Bruce McManus
20 Predicting and Assessing an Inflammatory Disease and Its
Complications: Example from Rheumatoid Arthritis 399
Christina Trollmo and Lars Klareskog
21 Pharmacokinetic and Pharmacodynamic Biomarker Correlations 413
J.F. Marier and Keith Gallicano
22 Validating In Vitro Toxicity Biomarkers Against
Clinical Endpoints 433
Calvert Louden and Ruth A. Roberts
PART VI BIOMARKERS IN CLINICAL TRIALS 443
23 Opportunities and Pitfalls Associated with Early Utilization of
Biomarkers: Case Study in Anticoagulant Development 445
Kay A. Criswell
24 Integrating Molecular Testing Into Clinical Applications 463
Anthony A. Killeen
25 Biomarkers for Lysosomal Storage Disorders 475
Ari Zimran, Candida Fratazzi, and Deborah Elstein
26 Value Chain in the Development of Biomarkers for
Disease Targets 485
Charles W. Richard, III, Arthur O. Tzianabos, and Whaijen Soo
PART Vn LESSONS LEARNED: PRACTICAL ASPECTS
OF BIOMARKER IMPLEMENTATION 493
27 Biomarkers in Pharmaceutical Development: The Essential
Role of Project Management and Teamwork 495
Lena King, Malle Jurima-Romet, and Nita Ichhpurani
viii CONTENTS
28 Integrating Academic Laboratories Into Pharmaceutical
Development 515
Peter A. Ward and Kent J. Johnson
29 Funding Biomarker Research and Development Through
the Small Business Innovative Research Program 527
James Varani
30 Novel and Traditional Nonclinical Biomarker Utilization
in the Estimation of Pharmaceutical Therapeutic Indices 541
Bruce D. Car, Brian Gemzik, and William R. Foster
31 Anti-Unicorn Principle: Appropriate Biomarkers Don t
Need to Be Rare or Hard to Find 551
Michael R. Bleavins and Ramin Rahbari
32 Biomarker Patent Strategies: Opportunities and Risks 565
Cynthia M. Bott and Eric J. Baude
PART VIII WHERE ARE WE HEADING AND WHAT DO
WE REALLY NEED? 575
33 IT Supporting Biomarker-Enabled Drug Development 577
Michael Hehenberger
34 Redefining Disease and Pharmaceutical Targets Through
Molecular Definitions and Personalized Medicine 593
Craig P. Webb, John F. Thompson, and Bruce H. Liftman
35 Ethics of Biomarkers: The Borders of Investigative Research,
Informed Consent, and Patient Protection 625
Heather Walmsley, Michael Burgess, Jacquelyn Brinkman,
Richard Hegele, Janet Wilson-McManus, and Bruce McManus
36 Pathodynamics: Improving Biomarker Selection by Getting
More Information from Changes Over Time 643
Donald C. Trost
37 Optimizing the Use of Biomarkers for Drug Development:
A Clinician s Perspective 693
Alberto Gimona
38 Nanotechnology-Based Biomarker Detection 709
Joshua Reineke
INDEX 731
|
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| dewey-raw | 615/.10724 |
| dewey-search | 615/.10724 |
| dewey-sort | 3615 510724 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie Medizin |
| format | Book |
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| spellingShingle | Biomarkers in drug development a handbook of practice, application, and strategy Biochemical markers Drug development Biomarkers, Pharmacological Drug Design Drug Discovery Arzneimitteldesign (DE-588)4278218-1 gnd Arzneimittelentwicklung (DE-588)4143176-5 gnd Biomarker (DE-588)4425928-1 gnd |
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| title | Biomarkers in drug development a handbook of practice, application, and strategy |
| title_auth | Biomarkers in drug development a handbook of practice, application, and strategy |
| title_exact_search | Biomarkers in drug development a handbook of practice, application, and strategy |
| title_full | Biomarkers in drug development a handbook of practice, application, and strategy ed. by Michael R. Bleavins ... |
| title_fullStr | Biomarkers in drug development a handbook of practice, application, and strategy ed. by Michael R. Bleavins ... |
| title_full_unstemmed | Biomarkers in drug development a handbook of practice, application, and strategy ed. by Michael R. Bleavins ... |
| title_short | Biomarkers in drug development |
| title_sort | biomarkers in drug development a handbook of practice application and strategy |
| title_sub | a handbook of practice, application, and strategy |
| topic | Biochemical markers Drug development Biomarkers, Pharmacological Drug Design Drug Discovery Arzneimitteldesign (DE-588)4278218-1 gnd Arzneimittelentwicklung (DE-588)4143176-5 gnd Biomarker (DE-588)4425928-1 gnd |
| topic_facet | Biochemical markers Drug development Biomarkers, Pharmacological Drug Design Drug Discovery Arzneimitteldesign Arzneimittelentwicklung Biomarker Aufsatzsammlung |
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