Similarity Factor Results
| Parameter | Value | Criterion | Status |
|---|---|---|---|
| f1 (Difference Factor) | 12.34 | 0 – 15 (acceptable range) | PASS |
| f2 (Similarity Factor) | 57.87 | ≥ 50 (acceptable range) | PASS |
| Timepoints used (n) | 6 | ≥ 3 recommended | OK |
f2 >= 50 supports similarity between the reference and test profiles.
Dissolution Profile Data
| Time (min) | reference Mean (%) | test Mean (%) | Difference (%) |
|---|---|---|---|
| 5.0 | 15.00 | 12.07 | -2.93 |
| 10.0 | 30.00 | 24.03 | -5.97 |
| 15.0 | 48.00 | 40.00 | -8.00 |
| 20.0 | 62.03 | 54.97 | -7.07 |
| 30.0 | 78.00 | 70.07 | -7.93 |
| 45.0 | 90.03 | 82.07 | -7.97 |
Disclaimer
Regulatory Notice
This report was generated using OpenPKFlow (open-source). Final regulatory interpretation should be reviewed by qualified formulation, pharmacokinetic, and regulatory experts.