Clinical Trial Simulations: Applications and Trends

ISBN-13: 9781461427841 / Angielski / Miękka / 2013 / 540 str.

Holly H. C. Kimko; Carl C. Peck

Opis

There have been tremendous advancements in application of modeling and simulation (M&S) in drug development during the last decade. The pharmaceutical companies started to pay more attention to implement simulation exercises in drug development in order to achieve cost effectiveness. The Food and Drug Administration (FDA) published a white paper titled, Critical Path Initiatives, in March 2004. This puts forward model based drug development that calls for use of quantitative M&S to facilitate informed decisions. The European Medicines Agency (EMEA) also encourages use of simulations in guiding drug development. With this much interest, Clinical Trial Simulations will serve as a reference to understand how clinical trial simulations are being used in drug development. Clinical Trial Simulations compiles the topics of recent interest and the case studies of how clinical trial simulations were used in various therapeutic areas. It is divided into parts that describe subjects that have gained interest recently; application of M&S in regulatory decisions; application of M&S in various therapeutic areas; and special use of M&S.

Recenzje

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)

Spis treści

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 Oscar E. Della Pasqua 14.Application of Pharmacokinetic-Pharmacodynamic Modeling and Simulation for Erythropoietic Stimulating Agents Juan José Pérez Ruixo, Sameer Doshi, and Andrew Chow 15.Model Based Development of an Agent for the Treatment of Generalized Anxiety Disorder Peter A. Lockwood and Jaap W. Mandema 16.Balancing Efficacy and Safety in the Clinical Development of an Atypical Antipsychotic, Paliperidone Extended-Release Filip De Ridder and An Vermeulen Expanded Applications of M&S 17.Application of Modeling and Simulation in the Development of Protein Drugs Lorin K. Roskos, Song Ren, and Gabriel Robbie 18.Modeling and Simulation in Pediatric Research and Development Jeffrey S. Barrett Evolving Methodologies in M&S 19.Disease Progression Analysis: Towards Mechanism-Based Models Stephan Schmidt, Teun M. Post, Massoud A. Boroujerdi, Charlotte Van Kesteren, Bart A. Ploeger, Oscar E. Della Pasqua, and Meindert Danhof 20.Using a Systems Biology Approach to Explore Hypotheses Underlying Clinical Diversity of the Renin Angiotensin System and the Response to Antihypertensive Therapies Arthur Lo, Jennifer Beh, Hector De Leon, Melissa K. Hallow, Ramprasad Ramakrishna, Manoj Rodrigo, Anamika Sarkar, Ramesh Sarangapani, and Anna Georgieva 21.Recent Developments in Physiologically Based Pharmacokinetic Modeling Vikash Sinha and Holly H.C. Kimko 22.Covariate Distribution Models in Simulation Peter L. Bonate

O autorze

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.

Blurb

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.