Biomarkers in clinical drug development
著者
書誌事項
Biomarkers in clinical drug development
（Drugs and the pharmaceutical sciences, v. 132）
Marcel Dekker, c2003
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注記
HTTP:URL=http://www.loc.gov/catdir/toc/fy045/2004270241.html Information=Table of contents
Includes bibliographies and index
内容説明・目次
内容説明
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.
目次
- 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.
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