Description - Biomarkers in Drug Development by Michael R. Bleavins
Discover how biomarkers can boost the success rate of drug
development efforts
As pharmaceutical companies struggle to improve the success rate
and cost-effectiveness of the drug development process, biomarkers
have emerged as a valuable tool. This book synthesizes and reviews
the latest efforts to identify, develop, and integrate biomarkers
as a key strategy in translational medicine and the drug
development process. Filled with case studies, the book
demonstrates how biomarkers can improve drug development timelines,
lower costs, facilitate better compound selection, reduce
late-stage attrition, and open the door to personalized
medicine.
Biomarkers in Drug Development is divided into eight
parts:
Part One offers an overview of biomarkers and their role in drug
development.
Part Two highlights important technologies to help researchers
identify new biomarkers.
Part Three examines the characterization and validation process
for both drugs and diagnostics, and provides practical advice on
appropriate statistical methods to ensure that biomarkers fulfill
their intended purpose.
Parts Four through Six examine the application of biomarkers in
discovery, preclinical safety assessment, clinical trials, and
translational medicine.
Part Seven focuses on lessons learned and the practical aspects
of implementing biomarkers in drug development programs.
Part Eight explores future trends and issues, including data
integration, personalized medicine, and ethical concerns.
Each of the thirty-eight chapters was contributed by one or more
leading experts, including scientists from biotechnology and
pharmaceutical firms, academia, and the U.S. Food and Drug
Administration. Their contributions offer pharmaceutical and
clinical researchers the most up-to-date understanding of the
strategies used for and applications of biomarkers in drug
development.
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Biomarkers in Drug Discovery and Development: A Handbook of Practice, Application, and Strategy
