f2 Similarity Calculator
Dissolution Profile Comparison | FDA/EMA Regulatory Compliance | ANDA Submission
f2 > 50 = Similar (Pass) | f2 < 50 = Different (Fail)
Test Product (Generic)
Dissolution Profile (% dissolved)
✓ Pass Example
✗ Fail Example
⚖ Borderline
Time Points (minutes)
5, 10, 15, 20, 30, 45, 60
Reference Product (Innovator)
Dissolution Profile (% dissolved)
✓ Pass Example
✗ Fail Example
⚖ Borderline
Calculate f2 Similarity
f2 Similarity Results
Regulatory Guidance
FDA Guidance:
f2 ≥ 50 indicates similar profiles
EMA Guidance:
Same criteria (f2 ≥ 50)
WHO:
f2 ≥ 50 for multisource products
ICH Q1E:
Requires 12 units per time point