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Number of Failed BE Studies Reviewed at FDA’s OGD Since the “All Bioequivalence Studies” Rule Became Effective in July 2009
| Description | BE Studies | ANDAs | ||
|---|---|---|---|---|
| Number | Percent of total | Number | Percent of total | |
| Within-subject variability of AUC and C max ≥ 30% | 92 | 45 | 45 | 37 |
| Within-subject variability of AUC and C max < 30% | 113 | 55 | 76 | 63 |
| Totals | 205 | 100 | 121 | 100 |
