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 316 p.
  • 言語 ENG
  • 商品コード 9780824740269
  • DDC分類 615.19

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.

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 modelling and clinical trial simulation, Wayne Colburn; pharmacogenomic biomarkers, Richard Hockett and Sandra Kirkwood; quality assurance 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.