A recent FDA presentation (delivered as part of the AAPS eLearning Webinar Series) described the measurable impact that the interdisciplinary science of pharmacometrics, also called "model-based drug development," is having on drug approval and labeling decisions. This presentation also proposed how End of Phase IIa meetings with FDA, to review model-based results offer the potential for game-changing success to cut late-phase attrition.

The following short case study from Pharsight's consulting practice offers further evidence of the impact and value of pharmacometric analysis. Integrated modeling of Phase II and literature data for a sponsor's CNS compound, combined with simulation of Phase III trial designs, provided a compelling case to FDA to support registration, without running an additional pivotal Phase III trial - saving months of development effort, millions of dollars and offering the promise of making a beneficial treatment available to patients much sooner. FDA recently approved the drug candidate in the target indication.

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