f2 similarity factor (dissolution)
The f2 similarity factor (FDA/CDER & EMA) compares two dissolution profiles point-by-point: f2 = 50·log{[1 + (1/n)Σ(Rt−Tt)²]^−0.5 × 100}. f2 ≥ 50 (i.e., average difference ≤10%) declares the profiles equivalent. For supplements with bioavailability claims or post-approval chan...
The f2 similarity factor (FDA/CDER & EMA) compares two dissolution profiles point-by-point: f2 = 50·log{[1 + (1/n)Σ(Rt−Tt)²]^−0.5 × 100}. f2 ≥ 50 (i.e., average difference ≤10%) declares the profiles equivalent. For supplements with bioavailability claims or post-approval changes (excipient swap, supplier change, scale-up), f2 is the pragmatic before/after equivalence test that avoids a clinical study.
- FDA SUPAC-IR
- EMA Bioequivalence Guideline
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