© 2014

Handbook of Anticancer Pharmacokinetics and Pharmacodynamics

  • Michelle A. Rudek
  • Cindy H. Chau
  • William D. Figg
  • Howard L. McLeod

Part of the Cancer Drug Discovery and Development book series (CDD&D)

Table of contents

  1. Front Matter
    Pages i-ix
  2. Christina M. Annunziata, Phillip A. Dennis
    Pages 1-21
  3. Angelika M. Burger, Heinz-Herbert Fiebig
    Pages 23-38
  4. Tawnya C. McKee, Albert W. W. Van Wyk, Emily L. Whitson
    Pages 39-67
  5. Bo Gao, Heinz-Josef Klumpen, Howard Gurney
    Pages 69-87
  6. Shivaani Kummar, James H. Doroshow
    Pages 89-97
  7. Hilary Glen, Jim Cassidy
    Pages 99-105
  8. H. Thomas Karnes, Kumar A. Shah
    Pages 117-139
  9. Uday B. Dandamudi, Andrew Beelen, Lionel D. Lewis
    Pages 141-157
  10. Jing Li, Michelle A. Rudek
    Pages 159-171
  11. Satjit S. Brar, Joga Gobburu
    Pages 173-192
  12. Kenneth S. Bauer, Fatemeh Tavakkoli
    Pages 193-208
  13. Alex Sparreboom, Walter J. Loos
    Pages 209-227
  14. David Jamieson, Sally A. Coulthard, Alan V. Boddy
    Pages 229-254
  15. Yuichi Ando
    Pages 273-288
  16. Pierre Bohanes, Heinz-Josef Lenz
    Pages 289-332
  17. Eddie Reed, Teri L. Larkins, Cindy H. Chau, William D. Figg
    Pages 333-349
  18. Laurent P. Rivory
    Pages 351-371

About this book


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


Cancer Pharmacodynamics Pharmacogenetics Pharmacokinetics Pharmacology

Editors and affiliations

  • Michelle A. Rudek
    • 1
  • Cindy H. Chau
    • 2
  • William D. Figg
    • 3
  • Howard L. McLeod
    • 4
  1. 1.Sidney Kimmel Comprehensive Cancer CenteBaltimoreUSA
  2. 2.Center for Cancer Research, National Cancer InstituteBethesdaUSA
  3. 3.Center for Cancer Research, National Cancer InstituteBethesdaUSA
  4. 4.Moffitt Cancer CenterTampaUSA

About the editors

Dr. Michelle Rudek received her BS in Pharmacy from the University of Pittsburgh and her dual Pharm.D., Ph.D. from Virginia Commonwealth University in a joint clinical pharmacology/oncology program with the National Cancer Institute.  Dr. Rudek joined Johns Hopkins University in 2001 and is currently an Associate Professor of Oncology and Director of the Analytical Pharmacology Core Laboratory.  Her research program is focused on clinical pharmacology with a focus on early phase drug development and special populations including AIDS malignancy and organ dysfunction.

Dr. Cindy H. Chau received her BS in Molecular, Cell, and Developmental Biology from UCLA and her Pharm.D. and Ph.D. (in Molecular Pharmacology and Toxicology) dual degrees from the University of Southern California School of Pharmacy as a National Institutes of Health (NIH) predoctoral fellow.  She was the recipient of the NIH National Research Service Award.  Dr. Chau completed a postdoctoral fellowship at the NIH, joining the National Cancer Institute in 2004 and is currently a research scientist within the Medical Oncology Branch, Center for Cancer Research.

Dr. William Douglas Figg received his B.S. (Hon) from Georgetown College, his B.S. in Pharmacy from Samford University and his Pharm.D. from Auburn University.  He completed his clinical pharmacy internship at the University of Alabama at Birmingham Hospital and his fellowship in drug development at the University of North Carolina-Chapel Hill.  Dr. Figg also received an M.B.A. degree from a combined program at Columbia University and London Business School.  He joined the Medical Oncology Branch, National Cancer Institute, National Institutes of Health in 1992. He has patented more than 80 new anticancer agents and four pharmacogenetic tests.

Dr. Howard McLeod is Fred Eshelman Distinguished Professor and Director, UNC Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill.  Dr. McLeod holds appointments in the UNC Schools of Pharmacy and Medicine, the Carolina Center for Genome Sciences, and the Lineberger Comprehensive Cancer Center.  Dr McLeod is chair of the NHGRI eMERGE network external scientific panel and is a member of the FDA committee on Clinical Pharmacology.  He is a member of the NIH NHGRI Advisory Council.  Since 2002, Dr. McLeod has been vice chair for Pharmacogenomics for the NCI clinical trials cooperative group CALGB/ALLIANCE, overseeing the largest oncology pharmacogenomics portfolio in the world.

Bibliographic information

  • Book Title Handbook of Anticancer Pharmacokinetics and Pharmacodynamics
  • Editors Michelle A. Rudek
    Cindy H. Chau
    William D. Figg
    Howard L. McLeod
  • Series Title Cancer Drug Discovery and Development
  • Series Abbreviated Title Cancer Drug Discovery,Development
  • DOI
  • Copyright Information Springer Science+Business Media New York 2014
  • Publisher Name Springer, New York, NY
  • eBook Packages Medicine Medicine (R0)
  • Hardcover ISBN 978-1-4614-9134-7
  • Softcover ISBN 978-1-4939-3898-8
  • eBook ISBN 978-1-4614-9135-4
  • Series ISSN 2196-9906
  • Series E-ISSN 2196-9914
  • Edition Number 2
  • Number of Pages IX, 836
  • Number of Illustrations 99 b/w illustrations, 46 illustrations in colour
  • Additional Information Originally published by Humana Press, Totowa, 2004
  • Topics Pharmacy
  • Buy this book on publisher's site


" 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