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Biomarkers in clinical drug development

Author: John C Bloom; Robert Allen Dean
Publisher: New York : Marcel Dekker, ©2003.
Series: Drugs and the pharmaceutical sciences, v. 132.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:

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

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Genre/Form: Aufsatzsammlung
Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: John C Bloom; Robert Allen Dean
ISBN: 9780824740269 0824740262
OCLC Number: 52362556
Description: viii, 295 pages : illustrations ; 24 cm.
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.
Series Title: Drugs and the pharmaceutical sciences, v. 132.
Responsibility: edited by John C. Bloom and Robert A. Dean.
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."the book has been written in an extremely functional style. This straightforward book is warmly and proudly recommended and cannot fail to be of great value to everyone concerned with acquiring a Read more...

 
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