Rudek, M.A., Chau, C.H., Figg, W., McLeod, H.L. (Eds.)
Originally published by Humana Press, Totowa, 2004
2nd ed. 2014, IX, 836 p. 145 illus., 46 illus. in color.
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Provides a detailed step-by-step guide to the successful design and approval of anticancer drugs
Features updated research from 1st Edition and new, additional chapters
Explores a wide variety of issues, including clinical trial design, preclinical screening, and the development and validation of bioanalytic methods
There are many steps on the road from discovery of an anticancer drug to securing its final approval by the Food and Drug Administration. In this thoroughly updated and expanded second edition of the Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, leading investigators synthesize an invaluable overview of the experimental and clinical processes of anticancer drug development, creating a single indispensable reference that covers all the steps from the identification of cancer-specific molecular targets to screening techniques and the development and validation of bioanalytical methods to clinical trial design and all phases of clinical trials. The authors have included new material on phase 0 trials in oncology, organ dysfunction trials, drug formulations and their impact on anticancer drug PK/PD including strategies to improve drug delivery, pharmacogenomics and cancer therapy, high throughput platforms in drug metabolism and transport pharmacogenetics, imaging in drug development and nanotechnology in cancer.
Authoritative and up-to-date, Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, 2nd Edition provides in one comprehensive and highly practical volume a detailed step-by-step guide to the successful design and approval of anticancer drugs.
Road map to anticancer drug development from discovery to NDA submission
Discussion of molecular targets and preclinical screening
Development and validation of bioanalytical methods
Chapters on clinical trial design and phase 0, I, II, III clinical trials
Pharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agents
Review of the drug development process from both laboratory and clinical perspectives
New technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development