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推薦指數：
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- 內容介紹
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Biomarkers in Clinical Drug Development
Edited by: John Bloom 1
Richard A. Dean 2
1 Lilly Research Laboratories, Indianapolis, Indiana, U.S.A.
2 Lilly Research Laboratories, Indianapolis, Indiana, U.S.A., and Indiana University School of Medicine, Indianapolis, U.S.A.
Book | Print Published: 05/20/2003
Hard Cover
304 pages | Illustrated
Print ISBN: 0-8247-4026-2
Description
Presenting recent applications in clinical development, pharmacokinetic/ pharmacodynamic modeling, and clinical trial simulation, this in-depth reference studies the role of biomarkers in successful drug formulation and development—utilizing the latest discoveries in biomarker science to determine the safety and efficacy of emerging drug compounds.
Table of Contents
Biomarkers in clinical Drug Development: Definitions and Disciplines
John C. Bloom
The Clinical Laboratory and Collection of Biomarker Data
Gordon F. Kapke and Robert A. Dean
Using Imaging Biomarkers to Demonstrate Efficacy in Clinical Trials: trends and Challenges
Charles G. Peterfy and Barbara Maley
Markers for Cardiac Repolarization and Risk Assessment
William J. Groh and Gregory D. Sides
Development and Application of Interspecies Biomarkers in Nonclinical Safety Evaluations
Frank D. Sistare
Validation of Assays for the Bioanalysis of Novel Biomarkers: Practical Recommendations for Clinical Investigation of New Drug Entities
Jean W. Lee, Gerald D. Norblom, Wendell C. Smith, and Ronald R. Bowsher
Validation of Biomarkers as Surrogates for Clinical Endpoints
Marc Buyse, Tony Vangeneugden, Luc Bijnens, Didier Renard, Tomasz Burzykowski, Helena Geys, and Geert Molenberghs
Biomarkers in Pharmacokinetic/Pharmacodynamic Modeling and Clinical Trial Simulation
Wayne Colburn
Pharmacogenomic Biomarkers
Richard Hockett and Sandra Kirkwood
Quality Assurace and Regulatory Compliance
Linda Knoob, Angela Berns, and Jacqueline Hevy
Biomarkers Strategies in Drug Development: Striking a Balance Between Opportunities and Liabilities
Robert A. Dean
Partnerships on Biomarker Research
Gregory Downing
Clinical Operations: Business Principles for Biomarker Applications
John C. Bloom
Index.
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