Table 4.

Results of the pharmacokinetic–pharmacodynamic evaluation of moxifloxacin in Japanese and Caucasian populations

Model parameters
Parameter		Estimate		Standard error	P value
Intercept		1.71		1.29	0.1876
Moxifloxacin plasma concentration		2.58		0.62	<0.0001
Country		2.58		1.82	0.1606
Concentration-by-country interaction		−0.24		0.89	0.7853
Estimates of prediction lines by ethnicity
Japan		USA		Japan/USA
Intercept	Slope vs. plasma concentration	Intercept	Slope vs. plasma concentration	Ratio of slopes	90% CI
1.71	2.58	4.29	2.34	1.10	(0.63, 1.82)***
Predicted ΔΔQTcF (ms) at the geometric mean of 3.07 ng ml–1
Country		Predicted ΔΔQTcF *	Standard error of predicted ΔΔQTcF	90% CI	P value
Japan		9.63	1.15		<0.0001
USA		11.46	1.19		<0.0001
Difference USA-Japan **		1.83	1.65	(−0.92, 4.58)	0.2722

CI confidence intervals;

^*The model is ΔΔQT_cF as a function of plasma concentration, country and the interaction of plasma concentration and country. The alpha level is 0.10.

^**Equivalence margins are set at –5 ms to +5 ms.

^***Equivalence margins are set at 0.50 to 2.00 with Caucasians as the reference group