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TitleHandbook of Anticancer Pharmacokinetics and Pharmacodynamics [electronic resource] / edited by William D. Figg, Howard L. McLeod
ImprintTotowa, NJ : Humana Press : Imprint: Humana Press, 2004
Connect tohttp://dx.doi.org/10.1007/978-1-59259-734-5
Descript XV, 623 p. online resource

SUMMARY

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


CONTENT

1 Molecular Targets -- 2 Preclinical Screening for New Anticancer Agents -- 3 Mouse Models in Cancer Drug Discovery and Development -- 4 Defining the Starting Dose: Should It Be Based on mg/kg, mg/m2or Fixed? -- 5 Phase I Trials in Oncology: Design and Endpoints -- 6 Analytical Methods: Development, Validation, and Clinical Applicability -- 7 Validation and Control of Bioanalytical Methods in Clinical Drug Development -- 8 Clinical Pharmacology Overview -- 9 Pharmacokinetic Modeling -- 10 Pharmacodynamic Modeling -- 11 Pharmacometric Knowledge-Based Oncology Drug Development -- 12 Protein Binding of Anticancer Drugs -- 13 Metabolism (Non-CYP Enzymes) -- 14 Cytochrome P450 and Anticancer Drugs -- 15 Polymorphisms in Genes of Drug Targets and Metabolism and in DNA Repair -- 16 Drug Interactions -- 17 ABC Transporters: Involvement in Multidrug Resistance and Drug Disposition -- 18 Intrathecal Chemotherapy -- 19 Use of Microdialysis in Preclinical and Clinical Development of Anticancer Agents -- 20 Regional Therapy of Cancer Using Continuous Hyperthermic Peritoneal Perfusion or Vascular Isolation and Perfusion Techniques -- 21 Isolated Lung Perfusion for the Treatment of Inoperable Pulmonary Malignancies -- 22 Pharmacokinetics of Isolated Lung Perfusion with Antitumor Agents -- 23 Central Nervous System Malignancy and Clinical Pharmacology -- 24 Pharmacokinetics of Anticancer Drugs in Children -- 25 Clinical Pharmacokinetics in the Elderly -- 26 The Combination of Angiogenesis Inhibitors and Radiotherapy for the Treatment of Primary Tumors -- 27 Gene Therapy for the Treatment of Cancer -- 28 Vaccines for the Treatment of Cancer -- 29 Pharmacokinetics of Antibodies and Immunotoxins in Mice and Humans -- 30 Pharmacokinetics of Biologicals -- 31 Exposureโ{128}{148}Response Relationship of Anticancer Agents: A Clinical Pharmacology and Biopharmaceutics Regulatory Perspective -- 32 Identifying Agents to Test in Phase III Trials -- 33 Clinical Trial Designs for Approval of New Anticancer Agents: A Clinical Science -- 34 Pharmacogenetic Counseling


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