Clinical Trial Simulations

1.Clinical Trial Simulation and Quantitative Pharmacology Carl C. Peck and Holly H.C. Kimko Application of M&S in Regulatory Decisions 2.Contribution of Modeling and Simulation Studies in the Regulatory Review: A European Regulatory Perspective Siv Jönsson, Anja Henningsson, Monica Edholm, and Tomas Salmonson 3.Contribution of Modeling and Simulation in the Regulatory Review and Decision-Making: U.S FDA Perspective Christine E. Garnett, Joo-Yeon Lee, and Jogarao V.S. Gobburu Strategic Applications of M&S in Drug Development 4.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, and Wayne Ewy 5.Decision-Making in Drug Development: Application of a Clinical Utility Index Timothy J. Carrothers, F. Lee Hodge, Robert J. Korsan, William B. Poland, and Kevin H. Dykstra 6.Adaptive Trial Designs José C. Pinheiro, Frank Bretz, and Chyi-Hung Hsu 7.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, and Thomas Kerbusch 8.Leveraging Pharmacometrics in Early Phase Anti-Inflamatory Dug Development Ene Ette and Christopher J. Godfrey Application of M&S in Selected Therapeutic Areas 9.The Application of Drug-Disease Models in the Development of Anti-Hyperglycemic Agents Jenny Y. Chien and Vikram P. Sinha 10.Modeling and Simulation in the Development of Cardiovascular Agents Diane R. Mould, Bill Frame, and Timothy Taylor 11.Viral Dynamic Modeling and Simulations in HIV and Hepatitis C Philippe Jacqmin and Eric Snoeck 12.A Model-Based PK/PD Antimicrobial Chemotherapy Drug Development Platform to Simultaneously Combat Infectious Diseases and Drug Resistance N. L'ntshotsholé "Shasha" Jumbe and George L. Drusano 13.PKPD and Disease Modeling: Concepts and Applications to Oncology

Holly H.C. Kimko is Senior Pharmacometrics Leader at the Department of Advanced Modeling & Simulation in Janssen Pharmaceutical Companies of Johnson & Johnson, Raritan, New Jersey, and Adjunct Professor in the faculty of the Pharmacy School of Rutgers University, New Jersey. During seven years prior to assuming her current position, she was 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 (1995) in Pharmaceutical Science from the State University of New York, Buffalo. She has published key papers on indirect response modeling and applications of clinical trial simulation and edited Simulation for Designing Clinical Trials together with Dr. Stephen B. Duffull. Dr. Kimko employs modeling and simulation tools in all clinical drug development and post-approval phases.

Carl C. Peck 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. Past positions include 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 focused his entire career on researching and optimizing methods to achieve greater informativeness, efficiency, speed and economy of drug development and regulation. Trained in mathematics and Medicine (University of Kansas 1963 and 1968), he was awarded an honorary doctorate degree Medicine by Sweden's University of Uppsala in 2002 in recognition of "outstanding contributions to the science of drug development". Dr. Peck has 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

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)

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)