Figg (National Cancer Institute) and McLeod (Washington University School of Medicine) supply an overview of experimental and clinical processes that lead to anticancer drugs, creating a reference that covers all steps of the drug development process, from the identification of cancer-specific targets to phase III clinical trials. Leading investigators furnish guidance on clinical trial design, preclinical screening, and the development and validation of bioanalytic methods, and describe techniques such as in vitro modeling and SAR analysis. The book sketches a roadmap to anticancer drug development from discovery to NDA submission, and will be of interest to pharmacologists, basic scientists, and medicinal chemists. Annotation ©2004 Book News, Inc., Portland, OR (booknews.com)
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.
Recenzijas
"...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." - Tumori
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 Jurgen Venitz The Combination of Angiogenesis Inhibitors and
Radiotherapy for the Treatment of Primary Tumors Kevin Camphausen and
Cynthia Menard 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 Hakan Mellstedt, Jan-Erik Frodin, and Anders Osterborg
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
