Book publication announcement: Clinical Trial Simulations

Dear all, I have hesitated to send this email for a while in this wide e-network, but I came to the conclusion that this IS a way to express my sincere wish that you find this book useful in your Modeling & Simulation endeavors, and to appreciate all the authors who have contributed to the book. The best experience in editing this book was that I found, unlike the first book on this topic in 2002, we have lots of good application cases to demonstrate utility of clinical trial simulations. Let's keep up the good work! J Best wishes, Holly Kimko Johnson & Johnson Pharmaceutical R&D, LLC ~~~~~~~~~~~~~ AAPS and Springer are delighted to announce the publication of the first volume in the AAPS Advances in the Pharmaceutical Sciences Series, "Clinical Trial Simulations" by Holly Kimko and Carl Peck. This book 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, it 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. Table of contents: 1. Clinical Trial Simulation and Quantitative Pharmacology Carl C. Peck and Holly H.C. Kimko Part 1: 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 Part 2: 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 I.Ette and Christopher J. Godfrey Part 3: Applications 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 T. 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 Part 4: 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 Part 5: 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 Further information can be found at http://www.springer.com/biomed/book/978-1-4419-7414-3?changeHeader=true . AAPS members can purchase the book at a 25% discount. -end-