Abstract:
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Over the years, modeling and simulation analyses have become important in supporting drug development decisions at all phases of drug development within pharmaceutical industry. Substantial work is performed by sponsors supporting decisions on dose selection, trial design, and dose individualization. However, when it comes time for interaction with the US FDA, there are often questions about how much materials should be provided, when should it be provided, and what materials are expected. This presentation will provide an overview on expectations from the FDA regarding the submission of modeling and simulation analyses to support regulatory decision making. Specifically, the talk will focus on format and content of pharmacometrics data sets for regulatory submission, communications prior to and during reviews, and expectations of documentations within pharmacometric reports.
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