Biomarkers in Clinical Drug Development

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.