Biomarkers in Clinical Drug Development
1st Edition
Published on 20. May 2003
Book
Hardback
316 pages
978-0-8247-4026-9 (ISBN)
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.
Reviews / Votes
"....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 proper knowledge of the utility of biomarkers."-Current Engineering Practice
More details
Series
Language
English
Place of publication
Bosa Roca
United States
Publishing group
Taylor & Francis Inc
Target group
Professional and scholarly
Academic, Professional, and Professional Practice & Development
Dimensions
Height: 229 mm
Width: 152 mm
Weight
589 gr
ISBN-13
978-0-8247-4026-9 (9780824740269)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
John Bloom | Richard A. Dean
Biomarkers in Clinical Drug Development
E-Book
05/2003
CRC Press
€251.99
Available for download
Persons
John Bloom, Richard A. Dean
Content
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.