Dissolution Similarity — f2

Compare a test dissolution profile against a reference with the similarity factor f2 (and f1). Applies the regulator-fixed rules automatically — ≥3 comparison points, at most one point ≥85% dissolved, %CV limits — and tells you plainly when f2 is not applicable. f2 ≥ 50 ⇒ similar (FDA 1997 / EMA CHMP/QWP).

1 · Enter the two profiles

Time points

Reference — % dissolved

Test — % dissolved

One value per line (or comma-separated), same number of points in each column. t=0 rows are ignored. Optional per-unit data for the %CV check can be sent via the API.

2 · Result

Applicability checks

Comparison window (points used for f2)

3 · Bootstrap f2 — confidence interval (optional)

The rigor route (Shah 1998) for when the classical f2 %CV limits are not met, or the estimate is borderline. Provide per-unit dissolution data (one dosage unit per line, values comma-separated matching the time points above). Profiles are declared similar when the lower 90% CI bound of f2 ≥ 50. The CI is reproducible (fixed seed).

Time points

Reference units — one per line

Test units — one per line

Computational dissolution-profile comparison. Not medical or regulatory advice; the biowaiver decision (BCS class, 85%/15min, solubility / permeability) is the responsibility of the user's regulatory team.