FDA Publishes Draft Guidance for Submitting Pharmacokinetic Modeling Analyses

The FDA outlined the format for submitting physiologically based pharmacokinetic analysis data to support product applications.

In a draft guidance, the agency recommended organizing the study report into five sections: an executive summary containing the rationale for the analysis, and an overview of the simulation’s development; a high-level synopsis of the drug’s properties, efficacy and safety information and past regulatory history; an overview of the modeling strategy and software design; and the results of efforts to confirm the validity of the model, including sensitivity analyses.

The report should conclude with a discussion of how the overall analysis addresses specific scientific questions; the basis for any requested waivers for clinical studies; and the limitations of the sponsor’s modeling approach and its impact on study results.