Main description:

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.

Contents:

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 Joensson, 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
Jose 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'ntshotshole "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 Jose Perez 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