Biomarkers in Clinical Drug Development de John Bloom

Biomarkers in Clinical Drug Development: Drugs and the Pharmaceutical Sciences

John Bloom

Richard A. Dean

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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Cuprins

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.

Descriere

While the scientific literature covers the use of novel and routine biomarkers for health maintenance and disease intervention, informed perspectives and advice on the unique challenges drug hunters face in the application of these increasingly sophisticated tools to the development, registration, and commercialization of pharmaceuticals is sorely lacking. Biomarkers in Clinical Drug Development fills this void. The book approaches the subject from three perspectives: (1) biomarker applied science, (2) strategic applications, and (3) clinical operations. The contributors highlight the principles, challenges, and technical approaches that will endure in an environment of rapid change.