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-