Reference Product

Test Product

Governing Equations

Weibull Dissolution Model:
  Q(t) = Qmax · (1 - exp(-(t/α)^β))

f2 Similarity Factor:
  f2 = 50 · log10(1 + (1/n)·Σ(Ri - Ti)²)^(-0.5) · 100

Simplified:
  f2 = 50 · log10(100 / sqrt(1 + (Σd²)/n))

Biowaiver Eligibility:
  f2 ≥ 50  →  Similar (biowaiver possible)
  f2 < 50  →  Not similar

f1 Difference Factor:
  f1 = (Σ|Ri - Ti| / ΣRi) · 100
  f1 ≤ 15 (supporting)

USP Apparatus: II (Paddle) at 50/75 rpm