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Pharmacokinetics in Drug Development

Problems and Challenges in Oncology, Volume 4

Editors: Bonate, Peter L., Howard, Danny R. (Eds.)

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  • Provides practical guidance on the application of pharmacokinetics as a drug development science  
  • Discusses the difficulties and challenges in clinical pharmacology and pharmacokinetic assessment in oncology patients  
  • Reviews design of TQT studies in oncology  
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eBook $169.00
price for USA in USD (gross)
  • ISBN 978-3-319-39053-6
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $219.99
price for USA in USD
  • ISBN 978-3-319-39051-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $219.99
price for USA in USD
  • ISBN 978-3-319-81805-4
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies.  This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely – to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamic concepts for tyrosine kinases, the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals,  clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist’s point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented.        

About the authors

Peter Bonate has acquired over 22 years of industrial experience: 19 years as a clinical pharmacologist/pharmacokineticist and three years in drug metabolism and bioanalysis.  He is currently Executive Director of Pharmacokinetics, Modeling, and Simulation at Astellas.  He received his PhD from Indiana University in Medical Neurobiology with an emphasis on the pharmacokinetics of drugs of abuse.  He also received an MS in statistics from the University of Idaho and an MS in Pharmacology from Washington State University.  He is a Fellow of the American College of Clinical Pharmacology and American Association of Pharmaceutical Scientists (AAPS).  Within AAPS he was a founder of the Pharmacometrics focus group, was chair of the Clinical Pharmacology and Translational Research Section, and was AAPS Fellows Committee Chair.  Dr. Bonate is a recipient of the AAPS Research Achievement Award in Clinical Pharmacology and Translational Research. He is currently an Associate Editor of the Journal of Pharmacokinetics and Pharmacodynamics.  He has served or currently serves on the editorial boards for the Journal of Clinical Pharmacology, Pharmaceutical Research, and the AAPS Journal.  He has more than 60 peer-reviewed publications and is author of the books Pharmacokinetic-Pharmacodynamic Modeling and Simulation, 2nd edition and Be a Model Communicator (and sell your models to anyone).  
Danny R. Howard received his Bachelor of Science degree in Pharmacy, and PhD from the University of Missouri in Kansas City. He joined Novartis as the Head of Global Pharmacokinetics and Pharmacodynamics, and is currently the Vice President of Oncology Clinical Pharmacology for the Novartis Oncology Business Unit. He began working in the pharmaceutical industry first as a biopharmaceutics consultant and then as pharmaceutical scientist for Marion Merrell Dow, Hoechst Marion Roussel, Aventis, and Quintiles. His career has included responsibilities in both clinical and nonclinical pharmacokinetics and pharmacodynamics, bioanalytics, pharmaceutical business operations and drug metabolism and pharmacokinetics. He has worked with numerous worldwide new drug submissions supporting both large and small molecules, within and outside the area of oncology. He was a charter member of the Missouri Biotech Association and served as its first Board Chairman. He is a member of American Association of Pharmaceutical Scientists (AAPS), American Society for Clinical Pharmacology and Therapeutics (ASCPT) and American Society of Clinical Oncology (ASCO). He is an accomplished author or coauthor of over 50 scientific publications and presentations in the area of clinical pharmacology and pharmaceutical sciences.

Reviews

“Part of the series Pharmacokinetics in Drug Development, this book focuses on the unique aspects in the development of oncology drugs. … the authors present the material at a level accessible to those already involved in PK/PD and drug development. … Overall, this is a good effort to provide insights into the complexities of oncology drug development for preclinical and clinical pharmacologists and clinicians.” (Gregory Reed, Doody's Book Reviews, February, 2017)


Table of contents (14 chapters)

Table of contents (14 chapters)

Buy this book

eBook $169.00
price for USA in USD (gross)
  • ISBN 978-3-319-39053-6
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $219.99
price for USA in USD
  • ISBN 978-3-319-39051-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $219.99
price for USA in USD
  • ISBN 978-3-319-81805-4
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Pharmacokinetics in Drug Development
Book Subtitle
Problems and Challenges in Oncology, Volume 4
Editors
  • Peter L. Bonate
  • Danny R. Howard
Copyright
2016
Publisher
Springer International Publishing
Copyright Holder
Springer International Publishing Switzerland
eBook ISBN
978-3-319-39053-6
DOI
10.1007/978-3-319-39053-6
Hardcover ISBN
978-3-319-39051-2
Softcover ISBN
978-3-319-81805-4
Edition Number
1
Number of Pages
XII, 330
Number of Illustrations
9 b/w illustrations, 23 illustrations in colour
Topics