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Presenter explains clinical assumptions and calculation methods for MDD conversions
Summary
The presenter said default assumptions (60 kg, 1.62 m^2) are used when labeling lacks patient-weight data, MDD is calculated over a 24-hour period (e.g., six doses if administered every four hours), and ophthalmic/topical/injectable conversion methods rely on application-specific volume, drop size/density or infusion-rate sums.
The Presenter outlined concrete clinical assumptions and calculation rules the agency uses when converting labeled dosing to an MDD numeric value. "We consider 60 kilogram body weight and 1.62 meter square body surface area for adult patients if we need that variable to determine a numeric value for the MDD," he said, noting reviewers may diverge when clinical judgment dictates.
He added that reviewers determine MDD over a 24-hour period and gave a concrete example: "If a drug is administered every 4 hours, we derive the MDD by considering 6 doses." For ophthalmics and topicals the Presenter described stepwise conversions — API per dose unit, number of units per day, then conversion to mass using application-specific drop size and density. For anesthetics the Presenter said MDD uses the maximum infusion rate and a 10‑hour surgery duration when labeling omits duration.
