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FDA says IVPT donor profiles overlapped across studies at one site; agency required repeat testing
Summary
In Case 3 the presenter described overlapping in vitro permeation test donor profiles across two studies at the same analytical site; FDA inspection led to OII classification and required repeating IVPT at a different CRO and BX reclassification for affected ANDAs.
The Agency official described Case 3 involving in vitro permeation testing (IVPT) in which donor profiles from two separate studies, when combined, showed overlapping profiles that were unlikely given IVPT variability. The presenter said OSID inspection classified the site OII and FDA required applicants to repeat the in vitro study at a different CRO.
The presenter noted that for some approved ANDAs the therapeutic-equivalence rating was changed to BX pending repeated, reliable data. The case underscored the agency's concern when cross-study overlapping profiles suggest potential data integrity problems rather than expected biological variability.
