Biomarkers in Clinical Drug Development

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Overview

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.
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Editorial Reviews

From The Critics
Reviewer: Aryeh Hurwitz, M.D.(University of Kansas School of Medicine)
Description: This book discusses the practicalities of implementing studies of clinical biomarkers in the process of drug development. Several chapters are devoted to validation, statistical, and regulatory concerns.
Purpose: Its purpose is to discuss the application of biomarkers to drug development, especially to provide "informed perspectives and advice on the unique challenges" involved in applying biomarkers to "development, registration, and commercialization of pharmaceuticals in today's environment." While such a book is clearly of use, the authors have not been entirely successful in achieving their goals. Several of the chapters are redundant. They provide practical guidance in collection, processing,and transport of clinical specimens and in handling of data. This information is readily available in standard texts of clinical pathology and chemistry.
Audience: The book is obviously targeted to people working in the pharmaceutical industry, who gather data for New Drug Applications and have to contend with regulatory agencies.
Features: Some of the chapters are excellent. Those on imaging biomarkers and on cardiac repolarization are standouts. The chapter on quality assurance and regulatory compliance has a valuable glossary of terms and abbreviations for the uninitiated. Many of the other chapters are too short and superficial to be self sufficient. The bibliographies of most chapters are reasonably current, although some cite no references past the year 2000. What is lacking is any meaningful coverage of biomarkers for common clinical conditions, such as cardiovascular, neurodegenerative, malignant, rheumatologic, psychiatric, and other diseases. In such conditions, which commonly take decades to develop, it would be useful to present and evaluate availability and validity of biomarkers for identifying susceptible patients and for following courses of their diseases and responses to drug therapy.
Assessment: This is an uneven book. Some chapters are well written, complete, current, and comprehensive enough to stand alone. Others are superficial, trivial, and laden with jargon. At a rather high price it is not a particularly good buy. Other recent books, such as Biomarkers of Disease: An Evidence-Based Approach, edited by Trull et al. (Cambridge University Press, 2002), and Biomarkers and Surrogate Endpoints: Clinical Research and Applications, edited by Downing (Elsevier, 2000), are better.

2 Stars from Doody
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Product Details

  • ISBN-13: 9780824740269
  • Publisher: Taylor & Francis
  • Publication date: 5/20/2003
  • 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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