Clinical Trial Simulations

1. Front Matter

   Pages i-xvi

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2. Application of M&S in Regulatory Decisions

   1. Front Matter

      Pages 13-13

      PDF

3. Clinical Trial Simulation and Quantitative Pharmacology

   1. Clinical Trial Simulation and Quantitative Pharmacology

      • Carl C. Peck, Holly H. C. Kimko

      Pages 1-11

4. Application of M&S in Regulatory Decisions

   1. Front Matter

      Pages 13-13

      PDF

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

      • Siv Jönsson, Anja Henningsson, Monica Edholm, Tomas Salmonson

      Pages 15-36

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

      • Christine E. Garnett, Joo Yeon Lee, Jogarao V. S. Gobburu

      Pages 37-57

5. Strategic Applications of M&S in Drug Development

   1. Front Matter

      Pages 59-59

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

      • Mike K. Smith, Jonathan L. French, Kenneth G. Kowalski, Matthew M. Hutmacher, Wayne Ewy

      Pages 61-83

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

      • Timothy J. Carrothers, F. Lee Hodge, Robert J. Korsan, William B. Poland, Kevin H. Dykstra

      Pages 85-107

   4. Adaptive Trial Designs

      • José C. Pinheiro, Frank Bretz, Chyi-Hung Hsu

      Pages 109-130

   5. Keys of Collaboration to Enhance Efficiency and Impact of Modeling and Simulation

      • Anthe S. Zandvliet, Rik de Greef, Anton F. J. de Haan, Pieta C. IJzerman-Boon, Maya Z. Marintcheva-Petrova, Bernadette M. J. L. Mannaerts et al.

      Pages 131-148

   6. Leveraging Pharmacometrics in Early Phase Anti-inflamatory Drug Development

      • Ene I. Ette, Christopher J. Godfrey

      Pages 149-172

6. Application of M&S in Selected Therapeutic Areas

   1. Front Matter

      Pages 173-173

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   2. The Application of Drug-Disease Models in the Development of Anti-Hyperglycemic Agents

      • Jenny Y. Chien, Vikram P. Sinha

      Pages 175-198

   3. Modeling and Simulation in the Development of Cardiovascular Agents

      • Diane R. Mould, Bill Frame, Timothy Taylor

      Pages 199-226

   4. Viral Dynamic Modeling and Simulations in HIV and Hepatitis C

      • Philippe Jacqmin, Eric Snoeck

      Pages 227-250

   5. A Model-Based PK/PD Antimicrobial Chemotherapy Drug Development Platform to Simultaneously Combat Infectious Diseases and Drug Resistance

      • N. L’ntshotsholé “Shasha” Jumbe, George L. Drusano

      Pages 251-279

   6. PKPD and Disease Modeling: Concepts and Applications to Oncology

      • Oscar E. Della Pasqua

      Pages 281-306

   7. Application of Pharmacokinetic–Pharmacodynamic Modeling and Simulation for Erythropoietic Stimulating Agents

      • Juan José Pérez-Ruixo, Sameer Doshi, Andrew Chow

      Pages 307-323

   8. Model Based Development of an Agent for the Treatment of Generalized Anxiety Disorder

      • Peter A. Lockwood, Jaap W. Mandema

      Pages 325-340

This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is 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. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.

• Application
• Clinical
• Kimko
• Peck
• Simulation
• Trend
• Trial

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)

• Department of Advanced Modeling & Simula, Janssen Research & Development, LLC, Raritan, USA

  Holly H. C. Kimko

• Dept. Biopharmaceutical Sciences, University of California, San Francisco, San Francisco, USA

  Carl C. Peck

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.

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