. 2021 Jul 2;10(8):878–889. doi: 10.1002/psp4.12662

TABLE 1.

Predicted versus observed PK parameters of acetaminophen, alprazolam, and caffeine in plasma and milk during lactation

Model parameter	Plasma					Milk
	Observed		Predicted		Ratio	Observed		Predicted		Ratio
	Mean	SD	Mean	SD	Ratio	Mean	SD	Mean	SD	Ratio
Acetaminophen²⁰
Half‐life (h)	2.74	0.28	2.49	0.74	0.91	2.64	0.63	2.48	0.74	0.94
AUC_INF (mg/L/h)	23.02	6.67	21.68	8.7	0.94	17.38	4.43	17.90	7.19	1.03
fu	0.802	0.0056	0.86	0.01	1.07	0.9745	0.0035	0.99	0.0	1.02
M/P ratio						0.76	0.04	0.83	0.01	1.09
Alprazolam²¹
C_max (ng/ml)	8.88	2.69	10.33	3.15	1.16	3.7	1.59	4.68	1.48	1.26
T_max (h)*	0.6	(0.45–2.65)	1.00	(0.75–1.30)	1.67	1.1	(0.45 – 3.83)	1.00	(0.75–1.30)	0.91
Half‐life (h)	12.52	3.53	11.27	5.27	0.90	14.46	6.27	11.27	5.27	0.78
CLpo (ml/min/kg)	1.15	0.32	1.04	0.36	0.90
M/P ratio						0.36	0.11	0.45	0.05	1.26
Caffeine
Oo et al., 1995²³
Half‐life (h)	5.6	1.8	5.81	5.29	1.0
CL_po (ml/min/Kg)	1.0	0.2	1.7	1.3	1.7
M/P ratio						0.70	0.06	0.69	0.03	1.0
Stavchansky et al., 1988²²
C_max (mg/L)	4.4	1.0	2.5	0.7	0.6	2.8	0.6	1.7	0.5	0.6
T_max (h)	0.8	0.2	1.4	0.5	1.8	1.1	0.5	1.5	0.5	1.3
Half‐life (h)	7.3	3.6	5.8	5.3	0.8	7.2	3.4	5.8	5.3	0.8
AUCt (mg/L.hr)	33.8	18.6	25.3	20.1	0.7	26.6	11.3	17.4	13.4	0.7
M/P ratio						0.82	0.05	0.70	0.04	0.9
Calvaresi et al., 2016²⁵, ^a
AUCt (mg/L.hr)						10.28		13.93	3.08	1.4
C_max (mg/L)						2.06		1.40	0.43	0.7
Half‐life (h)						4		5.84	5.27	1.5

Half‐life = elimination half‐life; AUC_INF, extrapolated area under the curve to infinity; AUC_t, AUC to last time of measurement; fu = fraction unbound; C_max = maximum concentration; T_max = time to reach C_max; CL_po = apparent total body clearance; M/P ratio = milk‐to‐plasma ratio; PK, pharmacokinetic; *median (range)

^{^a}

Individual value.