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AAPS Advances in the Pharmaceutical Sciences Series

Clinical Trial Simulations

Applications and Trends

Editors: Kimko, Holly H. C., Peck, Carl C. (Eds.)

  • Presents updates, new uses and issues concerning CTS, along with case studies on how clinical trial simulations are being applied in various therapeutic and application areas
  • Expands on the utility of CTS for informing decisions during drug development and regulatory review
  • Presents the fundamental concepts and background necessary for practical applications of simulation for clinical trial design and analysis
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Buy this book

eBook $229.00
price for USA (gross)
  • ISBN 978-1-4419-7415-0
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $289.00
price for USA
valid through October 16, 2017
  • ISBN 978-1-4419-7414-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $289.00
price for USA
  • ISBN 978-1-4614-2784-1
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

This edition presents a review of the principles and progress surrounding clinical trial simulations (CTS), along with case studies illustrating CTS in various therapeutic and application areas.  In addition, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter has been written by esteemed authors who have demonstrated expertise in state-of-the-art application of CTS. 

The target audience for the volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, regulatory review or guidance of clinical trials, and academic researchers and others working in drug development (e.g., clinicians, senior managers, project planning and regulatory affairs professionals). The focus is on the effective utilization  of CTS in decision mechanisms. Readers will gain broad knowledge on how CTS can improve the efficiency, informativeness, speed and economy of model-based drug development and regulation.

Holly H.C. Kimko, PhD is a senior pharmacometrics leader (Research Fellow) at the Department of Advanced Modeling & Simulation in Johnson & Johnson Pharmaceutical Research & Development, LLC, New Jersey, and Adjunct Professor in the faculty of the Pharmacy School of Rutgers University, New Jersey.  She was previously Assistant Professor in the Center for Drug Development Science in Georgetown University Medical School, Washington DC. Trained in biochemistry and pharmacy, Dr. Kimko earned her Ph.D. degree in Pharmaceutical Science from the State University of New York, Buffalo.  She has published key papers on indirect response modeling and applications of CTS, and co-edited Simulation for Designing Clinical Trials.

Carl C. Peck, MD is Adjunct Professor, Center for Drug Development Science in the Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco, California.  He was previously Director of the FDA Center for Drug Evaluation and Research, Assistant U.S. Surgeon General, and President of the American Society for Clinical Pharmacology and Therapeutics.  Dr. Peck has also held professorial appointments in the faculties of UCSF, USUHS, and Georgetown University.  He is an author of more than 150 original research papers, chapters and books concerning advanced concepts and techniques of quantitative pharmacology, trial designs, and pharmaco-statistical modeling and simulation.

About the authors

Holly H.C. Kimko, PhD is a senior pharmacometrics leader (Research Fellow) at the Department of Advanced Modeling & Simulation in Johnson & Johnson Pharmaceutical Research & Development, LLC, New Jersey, and Adjunct Professor in the faculty of the Pharmacy School of Rutgers University, New Jersey.  She was previously Assistant Professor in the Center for Drug Development Science in Georgetown University Medical School, Washington DC. Trained in biochemistry and pharmacy, Dr. Kimko earned her Ph.D. degree in Pharmaceutical Science from the State University of New York, Buffalo.  She has published key papers on indirect response modeling and applications of CTS, and co-edited Simulation for Designing Clinical Trials.

Carl C. Peck, MD is Adjunct Professor, Center for Drug Development Science in the Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco, California.  He was previously Director of the FDA Center for Drug Evaluation and Research, Assistant U.S. Surgeon General, and President of the American Society for Clinical Pharmacology and Therapeutics.  Dr. Peck has also held professorial appointments in the faculties of UCSF, USUHS, and Georgetown University.  He is an author of more than 150 original research papers, chapters and books concerning advanced concepts and techniques of quantitative pharmacology, trial designs, and pharmaco-statistical modeling and simulation.

Reviews

From the reviews:

“‘Clinical Trial Simulations: Applications and Trends’ covers the evolving use of mathematical simulation models to supplement and sometimes even replace clinical trials. The book is primarily intended for clinical trialists and drug development and regulatory scientists.” (Norman M. Goldfarb, Journal of Clinical Research Best Practice, Vol. 8 (7), July, 2012)


Table of contents (22 chapters)

  • Clinical Trial Simulation and Quantitative Pharmacology

    Peck, Carl C. (et al.)

    Pages 1-11

  • Contribution of Modeling and Simulation Studies in the Regulatory Review: A European Regulatory Perspective

    Jönsson, Siv (et al.)

    Pages 15-36

  • Contribution of Modeling and Simulation in the Regulatory Review and Decision-Making: U.S. FDA Perspective

    Garnett, Christine E. (et al.)

    Pages 37-57

  • Decision-Making in Drug Development: Application of a Model Based Framework for Assessing Trial Performance

    Smith, Mike K. (et al.)

    Pages 61-83

  • Decision-Making in Drug Development: Application of a Clinical Utility IndexSM

    Carrothers, Timothy J. (et al.)

    Pages 85-107

Buy this book

eBook $229.00
price for USA (gross)
  • ISBN 978-1-4419-7415-0
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $289.00
price for USA
valid through October 16, 2017
  • ISBN 978-1-4419-7414-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $289.00
price for USA
  • ISBN 978-1-4614-2784-1
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Clinical Trial Simulations
Book Subtitle
Applications and Trends
Editors
  • Holly H. C. Kimko
  • Carl C. Peck
Series Title
AAPS Advances in the Pharmaceutical Sciences Series
Series Volume
1
Copyright
2011
Publisher
Springer-Verlag New York
Copyright Holder
American Association of Pharmaceutical Scientists
eBook ISBN
978-1-4419-7415-0
DOI
10.1007/978-1-4419-7415-0
Hardcover ISBN
978-1-4419-7414-3
Softcover ISBN
978-1-4614-2784-1
Series ISSN
2210-7371
Edition Number
1
Number of Pages
XVI, 540
Topics