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Modeling and Simulation in Support of the Critical Path Initiative: Infrastructure, Challenges, Opportunities
To support continuing development of "Critical Path" technical infrastructure for model-based drug development, FDA and industry are installing
clinical pharmacology data repositories to house the information needed to support high productivity modeling and simulation. Beyond investments in technical infrastructure, data standards, and tools required for PK/PD data management and analysis,
continued industry investments in interdisciplinary skill sets, organizational capabilities, and delivery practices will be required to realize the full potential of modeling and simulation.
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The Role of Literature Models to Support Strategic Decision-Making in Clinical Drug Development
The development of a new drug is a high risk and costly activity that involves multiple decisions and tradeoffs. Model-based approaches for combining proprietary data on a specific compound with literature data of its likely competitors offer powerful tools for managing risks concerning dose selection, efficient and effective trial design and key "go/no-go" decisions.
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