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Presenter defines Maximum Daily Dose (MDD) as a regulatory standard for product safety review
Summary
A presenter explained that MDD is a numeric daily amount derived from labeled administration and used in impurity control, extractables/leachables evaluation, and consistent regulatory reviews; it is not clinical dosing guidance.
The Presenter laid out a working definition of the Maximum Daily Dose (MDD), saying the figure is a regulatory metric, not a clinical prescription. "For regulatory purposes, the MDD is a numeric value an amount per day, which is calculated based on the API reasonably administered within a day to most patients as described by labeling," the Presenter said.
The Presenter emphasized why the MDD matters to regulators: it is used to set impurity-control limits (including for nitrosamine impurities), establish analytical evaluation thresholds for extractables and leachables, and inform study design and reviews of new and generic drugs. The presentation stressed that MDD provides a multidisciplinary standard applied consistently across product life cycles rather than altering clinical practice.
