There are many steps on the road from discovery of an anticancer drug to securing its final approval by the U. S. Food and Drug Administration (FDA). In Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, leading investigators synthesize an invaluable overview of the experimental and clinical processes that lead to anticancer drugs, creating 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. They detail each step in the process, ranging from compound design and synthesis, screening techniques using in vitro models, and SAR analysis for lead optimization, to in vivo experiments, formulation, preclinical pharmacokinetics, formal toxicology, and phase I, II, and III trials. 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 road map for moving an agent to NDA submission.
Comprehensive and highly practical, Handbook of Anticancer Pharmacokinetics and Pharmacodynamics provides in one volume a detailed step-by-step guide to the successful design and approval of anticancer drugs.

Klappentext

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.

Inhalt

Molecular Targets Udai Banerji, Ian Judson, and Paul Workman Preclinical Screening for New Anticancer Agents Angelika M. Burger and Heinz-Herbert Fiebig Mouse Models in Cancer Drug Discovery and Development Edward A. Sausville and Melinda Hollingshead Defining the Starting Dose: Should It Be Based on mg/kg, mg/m2, or Fixed? Howard Gurney Phase I Trials in Oncology: Design and Endpoints James Cassidy Analytical Methods: Development, Validation, and Clinical Applicability Hans Ehrsson, Staffan Eksborg, and Jonas Bergh Validation and Control of Bioanalytical Methods in Clinical Drug Development H. Thomas Karnes Clinical Pharmacology Overview Andrew P. Beelen and Lionel D. Lewis Pharmacokinetic Modeling Sharyn D. Baker and Michelle A. Rudek Pharmacodynamic Modeling Kenneth S. Bauer and William P. Petros Pharmacometric Knowledge-Based Oncology Drug Development Paul J. Williams, James A. Uchizono, and Ene I. Ette Protein Binding of Anticancer Drugs Alex Sparreboom and Walter J. Loos Metabolism (Non-CYP Enzymes) Sally A. Coulthard and Alan V. Boddy Cytochrome P450 and Anticancer Drugs Yuichi Ando Polymorphisms in Genes of Drug Targets and Metabolism and in DNA Repair Jan Stoehlmacher, Syma Iqbal, and Heinz-Josef Lenz Drug Interactions, Laurent P. Rivory ABC Transporters: Involvement in Multidrug Resistance and Drug Disposition Susan E. Bates and Tito Fojo Intrathecal Chemotherapy Jeff Stone and Susan M. Blaney Use of Microdialysis in Preclinical and Clinical Development of Anticancer Agents William C. Zamboni Regional Therapy of Cancer Using Continuous Hyperthermic Peritoneal Perfusion or Vascular Isolation and Perfusion Techniques H. Richard Alexander, Maihgan A. Kavanagh,Steven K. Libutti, and James F. Pingpank Isolated Lung Perfusion for the Treatment of Inoperable Pulmonary Malignancies David S. Schrump Pharmacokinetics of Isolated Lung Perfusion with Antitumor Agents Suoping Zhai Central Nervous System Malignancy and Clinical Pharmacology Steve Y. Cho and Howard A. Fine Pharmacokinetics of Anticancer Drugs in Children Lisa C. Iacono, P. Kellie Turner, and Clinton F. Stewart Clinical Pharmacokinetics in the Elderly Patricia W. Slattum and Jürgen Venitz The Combination of Angiogenesis Inhibitors and Radiotherapy for the Treatment of Primary Tumors Kevin Camphausen and Cynthia Ménard Gene Therapy for the Treatment of Cancer H. Trent Spencer and Jacques Galipeau Vaccines for the Treatment of Cancer Philip M. Arlen, James Gulley, Lauretta Odogwu, and John L. Marshall Pharmacokinetics of Antibodies and Immunotoxins in Mice and Humans Victor Ghetie, E. Sally Ward, and Ellen S. Vitetta Pharmacokinetics of Biologicals Håkan Mellstedt, Jan-Erik Frödin, and Anders Österborg Exposure-Response Relationship of Anticancer Agents: A Clinical Pharmacology and Biopharmaceutics Regulatory Perspective Atiqur Rahman Identifying Agents to Test in Phase III Trials Thomas G. Roberts Jr., Thomas J. Lynch Jr., and Bruce A. Chabner Clinical Trial Designs for Approval of New Anticancer Agents: A Clinical Science Daniel D. Von Hoff Pharmacogenetic Counseling Jill M. Kolesar Index