Clinical Trial Simulations : Applications and Trends /

Detalles Bibliográficos
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Kimko, Holly H. C. (Editor ), Peck, Carl C. (Editor )
Formato: eBook
Lenguaje:English
Publicado: New York, NY : Springer New York : Imprint: Springer, 2011.
Edición:1st ed. 2011.
Colección:AAPS Advances in the Pharmaceutical Sciences Series, 1
Materias:
Tabla de Contenidos:
  • 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.