Clinical trial simulations: applications and trends

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 theutility of CTS for informing decisions during drug development and regulatoryreview. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volumeincludes 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. 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 andregulatory 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 INDICE: Clinical Trial Simulation and Quantitative Pharmacology.- Contribution of Modeling and Simulation Studies in the Regulatory Review: A European Regulatory Perspective.- Contribution of Modeling and Simulation in the Regulatory Review and Decision-Making: U.S FDA Perspective.- Decision-Making in Drug Development: Application of a Model Based Framework for Assessing Trial Performance.- Decision-Making in Drug Development: Application of a Clinical UtilityIndex.- Adaptive Trial Designs.- Keys of Collaboration to Enhance Efficiency and Impact of Modeling and Simulation.- Leveraging Pharmacometrics in Early Phase Anti-Inflamatory Dug Development.- The Application of Drug-Disease Models in the Development of Anti-Hyperglycemic Agents.- Modeling and Simulation in the Development of Cardiovascular Agents.- Viral Dynamic Modeling and Simulations in HIV and Hepatitis C.- A Model-Based PK/PD Antimicrobial Chemotherapy Drug Development Platform to Simultaneously Combat Infectious Diseases and Drug Resistance.- PKPD and Disease Modeling: Concepts and Applications to Oncology.-Application of Pharmacokinetic-Pharmacodynamic Modeling and Simulation for Erythropoietic Stimulating Agents.- Model Based Development of an Agent for the Treatment of Generalized Anxiety Disorder.- Balancing Efficacy and Safety in the Clinical Development of an Atypical Antipsychotic, Paliperidone Extended-Release.- Application of Modeling and Simulation in the Development of Protein Drugs.- Modeling and Simulation in Pediatric Research and Development.- DiseaseProgression Analysis: Towards Mechanism-Based Models.- Using a Systems Biology Approach to Explore Hypotheses Underlying Clinical Diversity of the Renin Angiotensin System and the Response to Antihypertensive Therapies.- Recent Developments in Physiologically Based Pharmacokinetic Modeling.- Covariate Distribution Models in Simulation

• ISBN: 978-1-4419-7414-3
• Editorial: Springer
• Encuadernacion: Cartoné
• Páginas: 456
• Fecha Publicación: 29/11/2010
• Nº Volúmenes: 1
• Idioma: Inglés