OpenPKFlow 2.0.0

Bioequivalence Report

ParameterAUCinf
Subjects24
Acceptance Limits0.80 -- 1.25
Generated2026-05-22 17:01
BIOEQUIVALENT
GMR = 1.0553  |  90% CI [0.9865, 1.1289]

Summary

GMR (T/R)
1.0553
90% CI Lower
0.9865
90% CI Upper
1.1289
CV Intra (%)
19.4%
90% Confidence Interval vs. Acceptance Window
0.69 0.80 (lower limit) GMR 1.055 1.25 (upper limit) 1.36

Per-Subject Data

subject sequence reference test ratio log_diff
1 RT 78.0922 93.5413 1.1978 0.1805
2 RT 91.2154 91.2485 1.0004 0.0004
3 RT 137.9859 183.6608 1.3310 0.2859
4 RT 104.9689 134.0253 1.2768 0.2444
5 RT 125.8673 140.2338 1.1141 0.1081
6 RT 115.5203 119.1077 1.0311 0.0306
7 RT 85.2897 81.7168 0.9581 -0.0428
8 RT 114.5096 92.2194 0.8053 -0.2165
9 RT 92.3902 121.6108 1.3163 0.2748
10 RT 92.2565 61.5422 0.6671 -0.4048
11 RT 102.4589 98.0023 0.9565 -0.0445
12 RT 68.2848 72.6841 1.0644 0.0624
13 TR 134.7218 164.8023 1.2233 0.2015
14 TR 84.5546 123.8770 1.4651 0.3819
15 TR 128.4112 161.3315 1.2564 0.2282
16 TR 103.4668 100.5349 0.9717 -0.0287
17 TR 146.6690 174.7511 1.1915 0.1752
18 TR 84.7900 67.8580 0.8003 -0.2228
19 TR 92.5012 126.8199 1.3710 0.3155
20 TR 108.8110 108.6222 0.9983 -0.0017
21 TR 57.5873 51.8373 0.9002 -0.1052
22 TR 122.9958 111.4858 0.9064 -0.0983
23 TR 147.0213 149.5849 1.0174 0.0173
24 TR 132.5383 126.2007 0.9522 -0.0490
This report was generated using OpenPKFlow -- an open-source Python workflow for pharmacometric analysis. Final regulatory interpretation should be reviewed by qualified formulation, pharmacokinetic, and regulatory experts.