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Table 6 Major pharmacokinetic parameters for BK0023 and Neupogen ® administered to normal and cyclophosphamide neutropenic rats following a single subcutaneous administration of 10, 30 and 100 μg/kg

From: Preclinical and clinical phase I studies of a new recombinant Filgrastim (BK0023) in comparison with Neupogen®

  

Normal rats

Product

Nominal dose μg/kg

Cmax ng/ml

Tmax hour

AUC ng · h/ml

t½ hour

BK0023

10

51

2

179

1.5

30

64

2

377

2.6

100

377

2

1582

2.6

Neupogen ®

10

14

1

65

1.8

30

68

2

369

2.4

100

272

1

1121

2.2

  

Neutropenic rats

BK0023

10

27

2

134

1.9

30

84

2

410

1.7

100

444

2

1558

1.8

Neupogen ®

10

31

2

132

2.0

30

87

2

485

2.5

100

309

2

1620

2.4

  1. Abbreviations: AUC Area under the serum concentration-time curve from time zero to infinity, C max Maximum observed serum concentration, T max time to Cmax, t (1/2) Elimination half-life associated with terminal shape (λ2) of a semilogarithmic concentration-time curve.
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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