Table 4 The Rpred/obs ratios for PK parameters of Nicardipine in healthy and diseased populations.

From: A PBPK modeling approach for personalized dose optimization of nicardipine in renal and hepatic dysfunction

Dose

Cmax (ng/mL)

AUC0–∞ (ng/mL.hr)

CL (L/h)

References

O.V.

P.V.

R Ratio

O.V.

P.V.

R Ratio

O.V.

P.V.

R Ratio

IV administration in healthy individuals

 210 ug/kg for 30 min

230.14

226.37

0.984

220.4

227.17

1.031

66.7

64.45

0.966

38

 0.16 mg/kg

424.69

511.05

1.203

217.84

203.58

0.934

51.41

55.01

1.07

33

 5 mg/hr for 3 h

123.3

105.44

0.855

447.32

360.76

0.806

33.53

41.58

1.24

34

 0.885 mg

8.69

6.65

0.765

12.62

11.27

0.893

70.13

78.56

1.12

35

 1.05 mg

34.65

29.25

0.844

21.08

21.58

1.023

49.8

48.66

0.977

36

 5 mg

194.79

140.65

0.722

109.96

112.26

1.021

45.47

44.54

0.979

37

Oral administration in healthy individuals

 30 mg

78.09

60.52

0.775

116.98

142.16

1.215

256.46

211.03

0.823

34

 40 mg

27.65

34.73

1.256

179.38

131.32

0.732

222.99

304.6

1.366

36

 30 mg

33.27

36.26

1.089

83.06

85.95

1.035

361.17

349.74

0.968

39

 30 mg

22.14

38.13

1.722

66.11

87.85

1.329

453.79

341.45

0.752

40

 20 mg

20.63

24.35

1.18

52.92

62.99

1.19

393.88

317.47

0.806

41

 30 mg

31.48

37.95

1.206

101.03

97.53

0.965

296.95

307.6

1.036

41

 20 mg

25.82

24.29

0.941

52.03

60.4

1.161

384.35

331.1

0.861

42

Oral administration in CKD population

 20 mg

33.04

27.25

0.825

86.09

75.19

0.872

232.22

266

1.15

41

 30 mg

55.02

31.86

0.579

152.02

103.50

0.680

194.45

290.44

1.494

41

Oral administration in LC population

 30 mg

67.12

74.45

1.109

307.21

173

0.563

97.65

173.41

1.775

39

  1. Cmax maximal plasma concentration, AUC0–∞ area underneath the curve from time zero to infinity, CL clearance, CKD chronic kidney disease, LC liver cirrhosis, IV intravenous, O.V. the observed parameter value, P.V. the predicted parameter value, R Ratio P.V./O.V.