TABLE 2

Clinically observed and Simcyp-predicted pharmacokinetic parameter estimates of crizotinib in humans after a single or 28-day repeated oral administration of crizotinib

	Single Dose (250 mg)		Repeated Doses (250 mg bid)
	C_max	AUC_0-∞	C_max	AUC_0-_τ
	ng/mL	ng⋅h/mL	ng/mL	ng⋅h/mL
Observed	87 (34)	1817 (33)	328 (25)	3054 (32)
Predicted
HLM^{^a}	89 (43)	3901 (57)	543 (41)	6494 (41)
P/O ratio^{^b}	1.0	2.1	1.7	2.1
HSP^{^a}	42 (52)	1745 (72)	273 (64)	3258 (65)
P/O ratio^{^b}	0.48	0.96	0.83	1.1

Data are expressed as geometric mean (% coefficient of variation) for single dose (n = 8 patients) and 28-day repeated doses (n = 5 patients).
↵^a Simcyp simulation was performed using TDI parameters from either HLM or HSP.
↵^b Calculated mean ratio of predicted to observed pharmacokinetic parameters.