Biomarkers in Clinical Drug Development

Biomarkers in Clinical Drug Development

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Taylor & Francis

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Biomarkers in Clinical Drug Development

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.

Product Details

ISBN-13: 9780824740269
Publisher: Taylor & Francis
Publication date: 05/20/2003
Series: Drugs and the Pharmaceutical Sciences Series , #132
Edition description: New Edition
Pages: 304
Product dimensions: 6.25(w) x 9.25(h) x 1.25(d)

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 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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