From:  A simple quantitative model for the prediction of exposure of renally excreted drugs in pregnant women: a comparison with whole body PBPK model

 Predicted and observed Cmax and AUC by SQM and whole body PBPK

ParametersObservedPredictedRatios
PregnancySQMPBPKSQMPBPK
Metformin (3rd trimester) [16]
Cmax (ng/mL)1,1351,0601,0680.930.94
AUC (ng·hr/mL)6,9376,4506,5630.930.95
Digoxin (3rd trimester) [16]
Cmax (ng/mL)0.80.70.840.881.05
AUC (ng·hr/mL)7.36.38.00.861.10
Emtricitabine (3rd trimester) [16]
Cmax (ng/mL)1.40.90.940.660.67
AUC (ng·hr/mL)8.06.48.00.801.0
Ceftazidime; 26.3–33.6 and 37–42 weeks for Caucasian and Japanese, respectively (only AUC values in mg·hr/L [17])
Caucasian 110143950.861.30
Japanese1201431040.871.19
Cefuroxime; 29 weeks (only AUC values in mg·hr/L [17])
Caucasian4258401.380.95
Aztreonam; 25–30 weeks, from Chinese healthy (only AUC values in mg·hr/L [17])
Japanese971211281.251.32
Japanese1181211421.031.20
Ceftriaxone; 29 weeks (only AUC values in mg·hr/L [17])
Caucasian1,5881,1951,8680.751.18
Imipenem; 30-32 weeks, from Chinese healthy (only AUC values in mg·hr/L [17])
Japanese2722320.821.19
Japanese1322321.702.46
Fluconazole; 7.5 weeks (5–10), Chinese healthy (only AUC values in mg·hr/L [17])
Chinese1211701301.401.07
Acyclovir Cmax (mg/L); 36 weeks for the first dose (1st) and 38 weeks for the rest [18]
400 mg PO, first dose0.700.560.620.800.89
400 mg PO TIDss0.900.560.720.620.80
400 mg PO TIDss0.740.560.700.760.95
200 mg PO TIDss0.430.370.340.860.79
Acyclovir, AUC (mg·hr/L) [18]
400 mg PO, first dose2.62.93.71.131.42
400 mg PO TIDss3.72.93.70.791.00
Emtricitabine [18]
Valade et al.; AUC (mg·hr/L), dose = 200 mg QD
15–28 weeks8.47.87.50.930.89
28–40 weeks8.26.77.40.820.90
39 weeks8.36.77.70.810.93
Colbers et al.; dose = 200 mg QD, 28–38 weeks
Cmax (mg/L)1.81.41.50.760.83
AUC (mg·hr/L)9.68.97.60.930.79
Stek et al.; 31–38 weeks
Cmax (mg/L)1.41.01.50.781.07
AUC (mg·hr/L)8.06.67.50.850.94
Lamivudine; dose = 300 mg PO steady state, 36–40 weeks
AUC (mg·hr/L)12.59.110.50.730.84
Metformin [18]
Eyal et al.; dose = 500 mg PO BID, Cmax (mg/L)
10–14 weeks1.221.451.271.191.04
22–26 weeks1.061.281.201.211.13
34–38 weeks1.141.101.230.961.08
Eyal et al.; dose = 500 mg PO BID, AUC (mg·hr/L)
10–14 weeks6.59.38.21.371.26
22–26 weeks6.17.87.71.291.26
34–38 weeks6.96.78.10.971.17
Liao et al.; dose = 500 mg PO BID; 26–38 weeks
AUC (mg·hr/L)7.76.77.90.881.03
Liao et al.; dose = 1,000 mg PO BID; 26–38 weeks
AUC (mg·hr/L)11.96.716.50.571.39
Cefazolin; 500 mg IV, 19–33 weeks [19]
AUC (mg·hr/mL)7683671.100.89
Cefuroxime; 750 mg IV, AUC (mg·hr/mL) [19]
13 weeks (11–35 week)4248431.151.02
42 weeks4746460.990.99
Cefradine; 500 mg IV, AUC (mg·hr/mL) [19]
15 weeks (10–29)2427261.121.05
Cefradine; 500 mg oral, 20 weeks (13–33) [19]
Cmax (mg/L)6.17.96.21.301.02
AUC (mg·hr/mL)25.321.415.70.850.62
Oseltamivir Carboxylate, Cmax (ng/mL) [20, 21]
First trimester1503782972.521.98
Second trimester1533182702.081.76
Third trimester1982722831.371.43
Oseltamivir Carboxylate, AUC (ng·hr/mL) [20, 21]
First trimester1,8283,3402,4691.831.35
Second trimester2,3252,8062,2261.210.96
Third trimester2,3672,4022,3811.011.01
Amoxicillin, AUC (μg·hr/mL)
Second trimester15.216.624.41.071.61
Third trimester14.914.024.00.941.61
Tenofovir, third trimester [22]
Cmax (mg/L)0.280.230.270.810.96
AUC (mg·hr/L)2.52.31.70.910.68
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SQM: simple quantitative model; ss: steady state; TID: three times daily