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Presenter details practical challenges converting labeling to mg/day for MDD
Summary
The presenter identified common sources of uncertainty in MDD calculation — mg/kg or mg/m2 dosing, vague topical descriptors like 'pea size', ophthalmic drop counts, and complex dosing scenarios — and emphasized the need for clinical judgment and standardized assumptions.
The Presenter outlined common sources of uncertainty that complicate conversion of labeling into an mg/day MDD. He pointed to labels that use mg/kg or mg/m2, or instructions such as "apply a pea size," and asked rhetorically, "What's a pea size? How much does that weigh?" — illustrating why numeric conversion often requires assumptions.
The talk singled out ophthalmic products as especially challenging because labeling rarely specifies whether one eye or both eyes are treated or how many drops are delivered per day, forcing reviewers to apply clinical judgment. The Presenter also listed complex scenarios — multiple indications, subpopulation regimens, and drugs dosed to effect — that require careful, standardized approaches to produce a representative MDD.
