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Panel: AUCinf considered case‑by‑case under M13A; Cmax remains a core metric
Summary
An online participant asked whether AUC infinity should be removed per M13A; the panel said M13A recommends AUCT and Cmax but AUCinf is evaluated case‑by‑case depending on product risk, and applicants should provide scientific justification.
An online attendee asked whether AUC infinity (AUCinf) should be removed as a target metric under ICH M13A guidance. Panelist Dr. Dan Damondi said M13A provides recommendations that include AUCT along with Cmax, but that AUCinf calculations are considered on a case‑by‑case basis depending on the drug product and its risk classification.
"We consider AUC infinity calculations depending upon the drug product and the risk calculation classification of that drug product," Damondi said. The panel emphasized applicants should present scientific rationale when proposing alternative metrics or waiving particular studies.
Why it matters: Bioequivalence metrics affect whether generics can rely on certain studies or must run additional testing; the agency’s case‑by‑case approach means developers should justify departures from standard metrics in submissions.
