Table 4 Results from the pairwise comparison of test vs. comparator products and the predefined acceptance criteria for ‘sameness’
Pairwise comparison | ‘Sameness’ acceptance criteria | Results | ‘Sameness’ pass/fail |
|---|---|---|---|
Generic SA1 vs. SA Canesten® (R1) | 90% CI for the marketed generic 1% CLZ creams should lie within the limits of 75–133.33% according to the FDA’s SUPAC-SS guidance | LL: 36.87% UL: 40.18% | Fail |
Generic SA2 vs. SA Canesten® (R1) | LL: 36.26% UL: 43.15% | Fail | |
Generic SA3 vs. SA Canesten® (R1) | LL: 51.61% UL: 59.38% | Fail | |
Generic SA4 vs. SA Canesten® (R1) | LL: 37.52% UL: 43.08% | Fail | |
Generic SA5 vs. SA Canesten® (R1) | LL: 33.94% UL: 36.33% | Fail | |
SA Canesten® (R1) vs. itself (positive control) | LL: 84.03% UL: 102.86% | Pass |