Clinical Trial Simulations Applications and Trends

Clinical Trial Simulations Applications and Trends / edited by Holly H. C. Kimko, Carl C. Peck.

This edition 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, the book expands on the utility of CTS for informing decisions during drug development and...

Full description

Saved in:
Bibliographic Details
Corporate Author: SpringerLink (Online service)
Other Authors: Kimko, Holly H. C. (Editor), Peck, Carl C. (Editor)
Format: eBook
Language:English
Published: New York, NY : Springer New York : Imprint: Springer, 2011.
Edition:1st ed. 2011.
Series:AAPS Advances in the Pharmaceutical Sciences Series, 1
Springer eBook Collection.
Subjects:
Medicine.
Pharmacology.
Biochemistry.
Electronic resources (E-books)
Online Access:Click to view e-book
Holy Cross Note:Loaded electronically.
Electronic access restricted to members of the Holy Cross Community.
Table of Contents:
  • 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 Utility Index
  • 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
  • Disease Progression 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.

Similar Items