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Table 3 In vivo pharmacodynamic parameters of nine generics and the innovator product of amikacin

From: Pharmacodynamics of nine generic products of amikacin compared with the innovator in the neutropenic mouse thigh infection model

Amikacin

AdjR2

Sy|x

E max

SE

ED 50

SE

N

SE

BD

SE

1LKD

SE

2LKD

SE

P value

(CFA)

BMS (innovator)

0.97

0.37

6.58

0.40

272

44.6

1.02

0.12

144

12.7

266

19.9

490

40.8

NA 

Carlon

0.93

0.65

5.58

0.33

160

27.0

2.01

0.49

132

17.3

190

28.6

288

55.8

0.055

FormasG

0.98

0.36

5.65

0.19

216

19.6

2.01

0.27

169

16.7

242

17.7

357

23.9

0.013

Gencol

0.99

0.24

5.10

0.14

122

11.0

2.26

0.43

110

8.30

157

15.5

248

37.1

0.001

Genven

1.00

0.17

5.36

0.07

209

13.2

3.35

0.31

185

11.9

232

13.6

301

17.8

<0.0001

Pisa

0.98

0.38

5.45

0.22

96

14.1

1.36

0.22

77

9.70

133

16.5

257

40.2

0.001

Quimicol

0.98

0.41

5.53

0.22

241

30.4

2.61

0.56

208

27.9

275

30.1

380

43.2

0.004

Scalpi

0.98

0.38

5.65

0.36

324

48.8

1.35

0.24

228

26.4

384

36.6

684

78.3

0.004

Serpharma

0.99

0.22

5.58

0.17

343

23.6

1.76

0.20

261

17.4

395

21.0

624

39.0

<0.0001

Zokumey

0.95

0.51

5.25

0.24

145

25.7

1.57

0.35

117

18.7

191

30.1

347

68.5

0.044

  1. AdjR 2 adjusted coefficient of determination, S y|x standard error of the estimate, CFA curve fitting analysis, E max maximum effect, SE standard error, ED 50 effective dose to kill 50 % of E max , N slope, BD bacteriostatic dose, 1LKD and 2LKD 1- and 2-log kill dose, respectively