Kimko, Holly H. C.

Clinical Trial Simulations

Kimko, Holly H. C. - Clinical Trial Simulations, ebook


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ISBN: 9781441974150
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Table of contents

1. Clinical Trial Simulation and Quantitative Pharmacology
Carl C. Peck, Holly H. C. Kimko

2. Contribution of Modeling and Simulation Studies in the Regulatory Review: A European Regulatory Perspective
Siv Jönsson, Anja Henningsson, Monica Edholm, 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, Jogarao V. S. Gobburu

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, Wayne Ewy

5. Decision-Making in Drug Development: Application of a Clinical Utility IndexSM

Timothy J. Carrothers, F. Lee Hodge, Robert J. Korsan, William B. Poland, Kevin H. Dykstra

6. Adaptive Trial Designs
José C. Pinheiro, Frank Bretz, Chyi-Hung Hsu

7. Keys of Collaboration to Enhance Efficiency and Impact of Modeling and Simulation
Anthe S. Zandvliet, Rik Greef, Anton F. J. Haan, Pieta C. IJzerman-Boon, Maya Z. Marintcheva-Petrova, Bernadette M. J. L. Mannaerts, Thomas Kerbusch

8. Leveraging Pharmacometrics in Early Phase Anti-inflamatory Drug Development
Ene I. Ette, Christopher J. Godfrey

9. The Application of Drug-Disease Models in the Development of Anti-Hyperglycemic Agents
Jenny Y. Chien, Vikram P. Sinha

10. Modeling and Simulation in the Development of Cardiovascular Agents
Diane R. Mould, Bill Frame, Timothy Taylor

11. Viral Dynamic Modeling and Simulations in HIV and Hepatitis C
Philippe Jacqmin, 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, 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, Andrew Chow

15. Model Based Development of an Agent for the Treatment of Generalized Anxiety Disorder
Peter A. Lockwood, Jaap W. Mandema

16. Balancing Efficacy and Safety in the Clinical Development of an Atypical Antipsychotic, Paliperidone Extended-Release
Filip Ridder, An Vermeulen

17. Application of Modeling and Simulation in the Development of Protein Drugs
Lorin K. Roskos, Song Ren, Gabriel Robbie

18. Modeling and Simulation in Pediatric Research and Development
Jeffrey S. Barrett

19. Disease Progression Analysis: Towards Mechanism-Based Models
Stephan Schmidt, Teun M. Post, Massoud A. Boroujerdi, Charlotte Kesteren, Bart A. Ploeger, Oscar E. Della Pasqua, 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 Leon, Melissa K. Hallow, Ramprasad Ramakrishna, Manoj Rodrigo, Anamika Sarkar, Ramesh Sarangapani, Anna Georgieva

21. Recent Developments in Physiologically Based Pharmacokinetic Modeling
Vikash Sinha, Holly H. C. Kimko

22. Covariate Distribution Models in Simulation
Peter L. Bonate

Keywords: Biomedicine, Biomedicine general, Pharmacology/Toxicology, Biochemistry, general

Publication year
AAPS Advances in the Pharmaceutical Sciences Series
Page amount
16 pages
Medicine, Health Care, Mode

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