Leading investigators synthesize the entire laboratory and clinical process of developing anticancer drugs to create a single indispensable reference that covers all the steps from the identification of cancer-specific targets to phase III clinical trials. These expert authors provide their best guidance on a wide variety of issues, including clinical trial design, preclinical screening, and the development and validation of bioanalytic methods. The chapters on identifying agents to test in phase III trials and on trial design for the approval of new anticancer agents offer a unique roadmap for moving an agent to NDA submission.weiterlesen