臨床医薬品開発におけるバイオマーカー<br>Biomarkers in Clinical Drug Development (Drugs and the Pharmaceutical Sciences)

臨床医薬品開発におけるバイオマーカー
Biomarkers in Clinical Drug Development (Drugs and the Pharmaceutical Sciences)

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  • 製本 Hardcover:ハードカバー版/ページ数 304 p.
  • 言語 ENG,ENG
  • 商品コード 9780824740269
  • DDC分類 615

基本説明

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.

Full Description


Presenting applications in clinical development, pharmacokinetic/ pharmacodynamic modelling and clinical trial simulation, this reference studies the role of biomarkers in successful drug formulation and development.

Table of Contents

Preface                                            iii
Contributors vii
Biomarkers in Clinical Drug Development: 1 (10)
Definitions and Disciplines
John C. Bloom
The Clinical Laboratory and Collection of 11 (20)
Biomarker Data
Gordon F. Kapke
Robert A. Dean
Using Imaging Biomarkers to Demonstrate 31 (42)
Efficacy in Clinical Trials: Trends and
Challenges
Charles G. Peterfy
Barbara Maley
Markers for Cardiac Repolarization and Risk 73 (24)
Assessment
William J. Groh
Gregory D. Sides
Development and Application of Interspecies 97 (22)
Biomarkers in Nonclinical Safety Evaluations
Frank D. Sistare
Validation of Assays for the Bioanalysis of 119(30)
Novel Biomarkers: Practical Recommendations
for Clinical Investigation of New Drug
Entities
Jean W. Lee
Wendell C. Smith
Gerald D. Nordblom
Ronald R. Bowsher
Validation of Biomarkers as Surrogates for 149(20)
Clinical Endpoints
Marc Buyse
Tony Vangeneugden
Luc Bijnens
Didier Renard
Tomasz Burzykowski
Helena Geys
Geert Molenberghs
Biomarkers for 169(20)
Pharmacokinetic/Pharmacodynamic Modeling
and Clinical Trial Simulations
Wayne A. Colburn
Pharmacogenomic Biomarkers 189(22)
Richard D. Hockett
Sandra C. Kirkwood
Quality Assurance and Regulatory Compliance 211(24)
Linda F. Knoob
Angela Berns
Jacqueline Hevy
Biomarker Strategies in Drug Development: 235(12)
Striking a Balance Between Opportunities
and Liabilities
Robert A. Dean
Partnerships in Biomarker Research 247(24)
Gregory J. Downing
Clinical Operations: Business Principles 271(10)
for Biomarker Applications
John C. Bloom
Index 281