Table 3 Population acceptance criteria and predicted versus observed results for lamotrigine in healthy adult and special population after IV infusion and PO administration.

From: A repository of protein abundance data of drug metabolizing enzymes and transporters for applications in physiologically based pharmacokinetic (PBPK) modelling and simulation

Study ID	Dose	Parameter	Mean observed (O)	Observed acceptance range	Mean predicted (P)	Predicted range	P/O ratio
IV infusion (healthy adult)
A1	67.8 mg	C_max	0.88	NA	1.76	1.74–1.77	2.00
A1	67.8 mg	AUC	31.33	NA	34.90	22.58–50.9	1.11
PO solution (healthy adult)
A2	100 mg	C_max	1.7	NA	1.54	1.51–1.56	0.91
A2	100 mg	AUC	66.5	NA	50.44	32.24–74.09	0.76
PO tablet (healthy adult)
A3	200 mg	C_max	2.46	1.99–3.04	3.05	2.98–3.09	1.24
A3	200 mg	AUC	94.6	70.82–126.37	101.17	64.73–148.48	1.07
A4	100 mg	C_max	1.8	1.4–2.3	1.54	1.51–1.56	0.86
A4	100 mg	AUC	59.9	40.9–87.7	50.44	32.24–74.09	0.84
PO capsule (healthy adult)
A5	25 mg	C_max	0.29	0.22–0.39	0.38	0.37–0.39	1.32
A5	25 mg	AUC	11.73	7.24–19	12.58	8.03–18.49	1.07
A6	30 mg	C_max	0.4	0.33–0.48	0.46	0.45–0.47	1.15
A6	30 mg	AUC	16.32	10.95–24.33	15.10	9.64–22.19	0.93
A7	60 mg	C_max	0.8	0.73–0.88	0.92	0.9–0.93	1.15
A7	60 mg	AUC	33.96	27.40–42.09	30.23	19.31–44.42	0.89
A8	120 mg	C_max	1.6	1.23–2.08	1.85	1.81–1.88	1.16
A8	120 mg	AUC	66	56.91–76.54	60.57	38.71–88.95	0.92
A9	240 mg	C_max	3.16	2.26–4.42	3.63	3.54–3.68	1.15
A9	240 mg	AUC	152.2	120.24–192.65	121.54	77.92–178.36	0.80
PO solution (HI adult, alcoholic cirrhosis liver)
A10	100 mg	C_max	1.56	NA	1.29	1.28–1.29	0.83
A10	100 mg	AUC	197	NA	226.74	209.00–240.92	1.15
PO solution (HI adult, hepatitis C cirrhosis liver)
A10	100 mg	C_max	1.56	NA	1.29	1.28–1.29	0.83
A10	100 mg	AUC	197	NA	168.11	153.31–182.04	0.85
PO tablet (early childhood)
P1	2 mg/kg	C_max	1.1	0.55–2.21	1.83	1.82–1.84	1.66
P1	2 mg/kg	AUC	42.2	21.10–84.38	76.51	69.60–83.97	1.81
PO tablet (middle childhood)
P2	2 mg/kg	C_max	1.67	1.28–2.18	1.71	1.70–1.72	1.02
P2	2 mg/kg	AUC	70.4	31.25–158.60	90.10	80.43–99.29	1.28
PO tablet (children)
P3	2 mg/kg	C_max	1.48	1.05–2.08	1.75	4.54–4.55	1.18
P3	2 mg/kg	AUC	61	31.04–119.86	77.45	92.31–109.55	1.27

Observed and predicted maximum plasma concentration (C_max, μg/mL) and area under the plasma concentration-time profile (AUC, μg٠h/mL) are shown for the IV and PO routes of administration. Acceptance criteria were derived based on observed clinical C_max and AUC data. NA means not applicable (situation where %CV for C_max and AUC data were not available). Study ID: A1⁶⁹, A2⁴⁸, A3⁷⁰, A4⁷¹, A5⁷², A6-A9⁷³, A10⁴⁸, P1-P3⁴⁷.

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Table 3 Population acceptance criteria and predicted versus observed results for lamotrigine in healthy adult and special population after IV infusion and PO administration.

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