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Table 2 Potency estimate and parameters derived from linear regression with their statistical comparison of generics versus innovator by Curve Fitting Analysis

From: Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics

Product

r2

Intercept [95% CI]

P-value

Slope [95% CI]

P-value

Potency Estimate (%)

AMK-BMS

0.99

9.006 [8.646 to 9.366]

0.8799

3.884 [3.619 to 4.148]

0.6559

100.00

AMK-Carlon

0.99

9.082 [8.651 to 9.514]

 

3.789 [3.472 to 4.105]

 

99.83

AMK-Gencol

0.99

9.238 [8.738 to 9.737]

 

3.731 [3.365 to 4.098]

 

100.51

AMK-Pisa

0.99

9.244 [8.860 to 9.629]

 

3.698 [3.416 to 3.980]

 

100.31

AMK-Scalpi

0.99

8.920 [8.552 to 9.287]

 

3.935 [3.665 to 4.204]

 

99.77

AMK-Sigma

0.99

8.945 [8.575 to 9.315]

 

3.926 [3.655 to 4.198]

 

99.89

GNT-SP

0.99

10.44 [10.16 to 10.720]

0.9472

3.881 [3.594 to 4.167]

0.9984

100.00

GNT-Abbott

0.98

10.00 [9.557 to 10.440]

 

4.150 [3.695 to 4.605]

 

99.72

GNT-Az pharma

0.98

10.02 [9.576 to 10.460]

 

4.021 [3.570 to 4.473]

 

99.68

GNT-Biochemie

0.98

10.08 [9.668 to 10.500]

 

4.038 [3.613 to 4.463]

 

99.75

GNT-Biogenta

0.98

10.13 [9.736 to 10.510]

 

3.925 [3.526 to 4.324]

 

99.74

GNT-Colmed

0.98

10.13 [9.701 to 10.550]

 

3.918 [3.483 to 4.354]

 

99.74

GNT-Genfar

0.99

10.04 [9.697 to 10.380]

 

4.091 [3.738 to 4.443]

 

99.73

GNT-Lab America

0.99

10.09 [9.708 to 10.470]

 

4.143 [3.754 to 4.532]

 

99.79

GNT-Labinco

0.99

10.11 [9.749 to 10.470]

 

3.994 [3.623 to 4.366]

 

99.76

GNT-La Sante

0.98

10.11 [9.668 to 10.550]

 

4.106 [3.655 to 4.558]

 

99.80

GNT-Memphis

0.98

10.15 [9.694 to 10.610]

 

3.935 [3.465 to 4.406]

 

99.77

GNT-MK

0.98

10.09 [9.672 to 10.510]

 

4.146 [3.715 to 4.577]

 

99.68

GNT-Ophalac

0.98

10.02 [9.571 to 10.460]

 

4.006 [3.549 to 4.463]

 

99.68

GNT-Pentacoop

0.98

10.13 [9.690 to 10.560]

 

3.962 [3.514 to 4.409]

 

99.76

GNT-Recipe

0.98

10.10 [9.700 to 10.510]

 

3.926 [3.512 to 4.340]

 

99.72

GNT-Scalpi

0.98

10.13 [9.720 to 10.540]

 

3.919 [3.501 to 4.337]

 

99.74

GNT-Sigma

0.98

10.36 [9.889 to 10.830]

 

4.109 [3.629 to 4.590]

 

100.02

VAN-Lilly

0.99

6.320 [5.715 to 6.924]

0.0201

5.562 [5.082 to 6.042]

0.8594

100.00

VAN-Abbott

0.99

5.782 [5.248 to 6.316]

 

5.558 [5.134 to 5.982]

 

98.51

VAN-APP

0.99

6.281 [5.734 to 6.828]

 

5.359 [4.925 to 5.793]

 

99.30

VAN-Proclin

0.99

6.388 [5.721 to 7.054]

 

5.462 [4.933 to 5.991]

 

99.90