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FDA presentation: analytical-data discrepancies caused an ANDA to fail bioequivalence analysis
Summary
In Case 1 the presenter said discrepancies between analytical raw data and SAS datasets changed concentration values; using the correct concentrations caused the study to fail bioequivalence criteria, underscoring CRO quality-control needs.
The Agency official described Case 1 as a fasting bioequivalence study in which the Office identified discrepancies between analytical raw data and the SAS dataset for subject A (0.25–1 hour). "When we use the correct concentration in the data analysis, the study failed to meet the bioequivalence criteria," the presenter said, demonstrating how reporting inconsistencies can change regulatory outcomes.
The presenter used the case to urge CROs to implement robust quality-management systems to detect and correct discrepancies before regulatory submission, noting that applicants may be asked to repeat studies if reliability cannot be assured.
