Overview
- Includes 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 An information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis
- Includes supplementary material: sn.pub/extras
Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 1)
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Table of contents (22 chapters)
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Front Matter
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Application of M&S in Regulatory Decisions
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Front Matter
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Clinical Trial Simulation and Quantitative Pharmacology
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Application of M&S in Regulatory Decisions
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Front Matter
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Strategic Applications of M&S in Drug Development
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Front Matter
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Application of M&S in Selected Therapeutic Areas
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Front Matter
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Keywords
About this book
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)
Editors and Affiliations
About the editors
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.
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
DOI: https://doi.org/10.1007/978-1-4419-7415-0
Publisher: Springer New York, NY
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: American Association of Pharmaceutical Scientists 2011
Hardcover ISBN: 978-1-4419-7414-3Published: 10 December 2010
Softcover ISBN: 978-1-4614-2784-1Published: 28 January 2013
eBook ISBN: 978-1-4419-7415-0Published: 09 December 2010
Series ISSN: 2210-7371
Series E-ISSN: 2210-738X
Edition Number: 1
Number of Pages: XVI, 540
Topics: Biomedicine general, Pharmacology/Toxicology, Biochemistry, general
Industry Sectors: Biotechnology, Chemical Manufacturing, Consumer Packaged Goods, Health & Hospitals, Pharma
