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The Business Case for Modeling and Simulation (M&S) - FDA’s Evolving View of the Role of M&S in Drug Development and Approval
FDA’s message on the importance of quantitative modeling and simulation, identified in its 2004 “Critical Path” whitepaper, underscores the need for a better product development toolkit. The move to increased reliance on model-based drug development at FDA is in fact several years old. The most recent FDA “Critical Path” initiatives in this area have begun to drive trial designs and involve sponsors in more intensive communication about model-based insights to support decision-making.
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Collaboration and Strategy Development -
Cephalon Uses Modeling and Simulation to Optimize its Flagship Product
When Cephalon first set out to expand the label of its flagship compound, it needed a factual basis to support a go/no-go decision for a previously unstudied indication. In response, Cephalon joined forces with scientists and decision analysts from Pharsight Corporation. Using the tools of modeling and simulation, the team explored the knowns and unknowns of the drug and indication, to design a trial based upon all available information.
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Technical Infrastructure Supporting a Model-Driven Future
How will industry manage the growing volume of PK/PD data as both sponsors and FDA take a more active role in the creation and evaluation of drug and disease models? When data are not readily available, the time needed to locate, clean, and prepare the data for analysis may cause delay in overall project execution and effective decision-making. Several important challenges must be met to move forward with deploying an integrated PK/PD data repository.
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