Table 5 Results from the pairwise comparison of test vs. comparator products and the predefined acceptance criteria for ‘sameness’

SA Canesten® (R₁) vs. CA Canesten® (R₂)

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: 85.78%

UL: 101.99%

Pass

Generic CA₁ vs. CA Canesten® (R₂)

LL: 56.54%

UL: 70.18%

Fail

Cream T₁ vs. SA Canesten® (R₁)

LL: 36.28%

UL: 40.25%

Fail

Cream T₂ vs. SA Canesten® (R₁)

LL: 92.30%

UL: 102.40%

Pass