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Examples of Our Work with CNS Therapies

Integrated Modeling and Simulation Approach to Support Competitive Assessment and Dose Selection in Alzheimer's Disease

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Decision-Focused Applications of Modeling and Simulation in CNS Drug Development:
Four Case Studies

  • Combining pre-clinical and clinical evidence to support an early Phase II go/no-go decision (generalized anxiety disorder)
  • Integrating dose-response modeling and decision analysis for late Phase II dose optimization (major depressive disorder)
  • Applying modeling and clinical trial simulation for proof-of-concept trial design and analysis (neurodegenerative disease)
  • Modeling, trial simulation and decision analysis in an adaptive trial design for proof of concept and dose finding (chronic psychiatric disorder)

Modeling and Simulation Applications in CNS Drug Development ®

Evaluating Safety and Efficacy Tradeoffs to Support Go/No-Go Decision for an Anti-Depressant in Early Development

Decision Analysis Clarifies a Difficult Go/No-Go Decision: The NK1 Antagonist Case

Label Expansion Case Study: Cephalon Modeling and Simulation Experience Developing Provigilâ„¢

The Collaborative and Strategic Benefits of Exploring Drug Models in Clinical Development

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Case Studies in Neuroscience Drug Development and Commercialization

Accelerating Profitable CNS Compound Development: Pre-clinical to Phase III, Bayesian Modeling, Adaptive Trial Design, Decision Analysis